U.S. patent application number 12/140157 was filed with the patent office on 2008-10-09 for communication station and software for interfacing with an infusion pump, analyte monitor, analyte meter, or the like.
This patent application is currently assigned to MINIMED INC.. Invention is credited to J. Jeffrey Barlow, Paul S. Cheney, Mike Dobbles, Mark C. Estes, Todd M. Gross, Clifford W. Hague, Luis J. Malave, Deborah Ruppert, John Shin, Kevin C. Wells, Jay Yonemoto.
Application Number | 20080249470 12/140157 |
Document ID | / |
Family ID | 46279275 |
Filed Date | 2008-10-09 |
United States Patent
Application |
20080249470 |
Kind Code |
A1 |
Malave; Luis J. ; et
al. |
October 9, 2008 |
Communication Station and Software for Interfacing with an Infusion
Pump, Analyte Monitor, Analyte Meter, or the Like
Abstract
A communication station is for use with a medical device (such
as an infusion pump) and a processing device (such as a computer).
The communication station includes a housing, a medical device
interface coupled to the housing, a processing device interface
coupled to the housing and a processor coupled to the housing. The
device interface interfaces with the medical device, and the
processing device interface interfaces with the processing device.
The processor provides a communication path between the medical
device and the processing device such that programming and
instructions may be communicated from the processing device to the
medical device and data may be transferred from the medical device
to the processing device. The communication station may be combined
with a system that is capable of generating reports either locally
or remotely. In addition, the medical device interface may be a
cradle that is configurable to attach to different shaped medical
devices.
Inventors: |
Malave; Luis J.; (Valencia,
CA) ; Estes; Mark C.; (Simi Valley, CA) ;
Yonemoto; Jay; (Diamond Bar, CA) ; Barlow; J.
Jeffrey; (Valencia, CA) ; Gross; Todd M.;
(Saugus, CA) ; Shin; John; (Glendale, CA) ;
Cheney; Paul S.; (Winnetka, CA) ; Dobbles; Mike;
(Burbank, CA) ; Hague; Clifford W.; (Sherman Oaks,
CA) ; Ruppert; Deborah; (Los Angeles, CA) ;
Wells; Kevin C.; (Santa Monica, CA) |
Correspondence
Address: |
Paul H. Kovelman, Esq.;MEDTRONIC MINIMED, INC.
18000 Devonshire Street
Northridge
CA
91325-1219
US
|
Assignee: |
MINIMED INC.
|
Family ID: |
46279275 |
Appl. No.: |
12/140157 |
Filed: |
June 16, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10180732 |
Jun 26, 2002 |
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12140157 |
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09409014 |
Sep 29, 1999 |
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10180732 |
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29087251 |
Apr 29, 1998 |
D434142 |
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09409014 |
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60102469 |
Sep 30, 1998 |
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60121565 |
Feb 25, 1999 |
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60134981 |
May 20, 1999 |
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Current U.S.
Class: |
604/151 |
Current CPC
Class: |
A61M 5/14244 20130101;
A61M 2205/3569 20130101; G16H 40/63 20180101; G16H 10/60 20180101;
A61M 2205/3561 20130101; G16H 20/17 20180101; G16H 40/67 20180101;
A61M 5/172 20130101; G16H 15/00 20180101; A61M 5/1723 20130101;
A61M 2209/086 20130101 |
Class at
Publication: |
604/151 |
International
Class: |
A61M 1/00 20060101
A61M001/00 |
Claims
1.-28. (canceled)
29. A communication system for use in monitoring medical treatment
of a patient, the system comprising: a plurality of medical devices
comprising at least an infusion device and a continuous glucose
monitor; a processing device including at least one embedded
computer program that is capable of causing the processing device
to perform: downloading data from the plurality of medical devices
used to treat a medical condition for a patient; recording the
downloaded data in a patient data file; integrating the data from
the infusion device with data previously or later downloaded from
the continuous glucose monitor and presenting the integrated data
in a user chosen report format; and a communication station
comprising: a housing; a medical device interface coupled to the
housing which interfaces with the plurality of medical devices; a
processing device interface coupled to the housing that interfaces
with the processing device; and a processor coupled to the housing,
the medical device interface and the processing device interface to
provide a communication path between the plurality of medical
devices and the processing device such that programming and
instructions may be communicated from the processing device to the
medical device and data may be transferred from the medical device
to the processing device.
30. The communication system in accordance with claim 29, wherein
the processing device is a computer.
31. The communication system in accordance with claim 29, wherein
the plurality of medical devices includes a glucose meter.
32. The communication system in accordance with claim 31, wherein
the user chosen report format displays glucose meter history with
the infusion pump history and the continuous glucose monitor
history to provide contemporaneous information showing the
relationship between the infusion pump, the glucose monitor and the
glucose meter.
33. The communication system in accordance with claim 29, wherein
the user chosen report format displays infusion pump history with
the continuous glucose monitor history to provide contemporaneous
information showing the relationship between the infusion pump and
the glucose monitor.
34. The communication system in accordance with claim 29, wherein
the processing device interface includes a communication circuit
for communicating with the processing device, and wherein the
processing device is a remotely located computer.
35. The communication system in accordance with claim 29, wherein
the remotely controlled computer runs software for a network data
management service that utilizes the data transferred from the
plurality of medical devices.
36. The communication system in accordance with claim 29, wherein
the communication station is used to program or change settings of
at least one of the plurality of medical devices.
37. The communication system in accordance with claim 29, wherein
the communication station is used to acquire the data from at least
one of the plurality of medical devices in real time.
38. The communication system in accordance with claim 29, wherein
the communication station is used to trouble shoot operation of at
least one of the plurality of medical devices.
39. The communication system in accordance with claim 29, wherein
user chosen report format is a member of a set of user chosen
report formats comprising a patient information/medical device
settings report, a log book report, a daily summary report screen,
a daily detail report screen, a weekly summary report, a weekly
details report, a two week modal day report, and a medical device
details report.
40. The communication system in accordance with claim 29, wherein
the user chosen report format temporally displays insulin
administration compared to blood glucose levels.
41. The communication system in accordance with claim 29, wherein
the user chosen report format displays ranges of blood glucose
levels over a period of time.
42. The communication system in accordance with claim 29, wherein
the user chosen report format displays percentages of blood glucose
levels above and below glucose goals.
43. The communication system in accordance with claim 29, wherein
the user chosen report format are chosen by using a corresponding
icon.
44. The communication system in accordance with claim 29, wherein
the user chosen report format contains information for both bolus
and basal insulin administered to the patient.
45. The communication system in accordance with claim 29, wherein
the user chosen report format contains alerts.
46. The communication system in accordance with claim 29, wherein
the step of presenting the integrated data further comprises
calculating a percentage of total insulin delivery in the form of a
bolus injection over a period of time.
47. The communication system in accordance with claim 29, wherein
the step of presenting the integrated data further comprises
calculating an average blood glucose level over a period of
time.
48. The communication system in accordance with claim 47, wherein
the step of presenting the integrated data further comprises
calculating a standard deviation.
49. The communication system in accordance with claim 29, wherein
the step of presenting the integrated data further comprises
transforming the data into graphical waveform data, wherein the
graphical waveform data represents the time at which the data
occurs.
50. The communication system in accordance with claim 33, further
displaying blood glucose levels from multiple predefined time
periods on the same scale of a single one of the multiple
predefined time periods within the user chosen report format, with
the blood glucose levels from the multiple predefined time periods
shown in an overlaid fashion relative to each other over the single
one of the predefined time periods.
51. The communication system in accordance with claim 50, wherein
each predefined time period is the time period of a single day or a
single week.
52. The communication system in accordance with claim 34, further
displaying blood glucose levels from multiple predefined time
periods on the same scale of a single one of the multiple
predefined time periods within the user chosen report format, with
the blood glucose levels from the multiple predefined time periods
shown in an overlaid fashion relative to each other over the single
one of the predefined time periods.
53. The communication system in accordance with claim 52, wherein
each predefined time period is the time period of a single day or a
single week.
Description
RELATED APPLICATIONS
[0001] This application claims priority on U.S. Provisional
application Ser. No. 60/102,469, filed Sep. 30, 1998 and entitled
"Communication Station For Interfacing With An Infusion Pump", U.S.
Provisional application Ser. No. 60/121,565, filed Feb. 25, 1999
and entitled "Glucose Monitor Communication System", and U.S.
Provisional application Ser. No. 60/143,981, filed May 20, 1999 and
entitled "Diabetes Integrated Management System", and is also a
Continuation-In-Part of U.S. patent application Ser. No.
29/087,251, filed Apr. 29, 1998 and entitled "Communication Station
for an Infusion Pump", all of which are specifically incorporated
by reference herein.
FIELD OF THE INVENTION
[0002] This invention relates to communication stations for medical
devices and, in particular embodiments, to a communication station
for use with infusion pumps, analyte monitors/meters such as
glucose monitors, glucose meters, or the like.
BACKGROUND OF THE INVENTION
[0003] Traditionally, many modern programmable infusion pumps
include internal memory for generating and storing data
representing actual pump operation over a period of time. The
stored data may be reviewed on a periodic basis by medical
personnel, so that the patient's condition and treatment regimen
can be closely monitored, and the pump reprogrammed as needed.
Unfortunately, data retrieval from the infusion pump and/or
physician-dictated modification of the basic infusion pump program
have required regular patient visits to a medical treatment
facility.
[0004] To overcome this drawback, raw data has been transferred
from an infusion pump to another data storage and/or processing
device. An example of a data transfer system for an infusion pump
is disclosed in U.S. Pat. No. 5,376,070 issued Dec. 27, 1994 to
Purvis et al. and is entitled "Data Transfer System for an Infusion
Pump," which is herein incorporated by reference. This device
relates to a relatively simple and effective data transfer system
that is designed for retrieving data from, and sending program data
to, a medication infusion pump. The data transfer system is
particularly suited for remote data transfer and/or reprogramming
of the infusion pump.
[0005] Over the years, bodily characteristics have been determined
by obtaining a sample of bodily fluid. For example, diabetics often
test for blood glucose levels. Traditional blood glucose
determinations have utilized a painful finger prick using a lancet
to withdraw a small blood sample. In addition, all of these systems
are designed to provide data at discrete points and do not provide
continuous data to show the variations in the characteristic
between testing times. The data representing the results of the
test are often stored in a memory of a glucose meter. The data is
then downloaded into a computer for later review. However, none of
these systems coordinate infusion pump data with the glucose meter
data. Also, these systems generally only download raw data and do
not provide for analysis and presentation of the data in a useful
format.
SUMMARY OF THE DISCLOSURE
[0006] It is an object of an embodiment of the present invention to
provide an improved communication station for medical devices,
which obviates for practical purposes, the above mentioned
limitations.
[0007] According to an embodiment of the invention, a communication
station is for use with a medical device and a processing device.
The communication station includes a housing, a medical device
interface coupled to the housing, a processing device interface
coupled to the housing and a processor coupled to the housing. The
medical device interface interfaces with the medical device, and
the processing device interface interfaces with the processing
device. The processor provides a communication path between the
medical device and the processing device such that programming and
instructions may be communicated from the processing device to the
medical device and data may be transferred from the medical device
to the processing device. In preferred embodiments, the medical
device is an infusion pump, analyte monitor, continuous glucose
monitor, glucose meter, or the like, and the processing device is a
computer. Also, in some embodiments, the medical device interface
is a cradle that is configurable to attach to different shaped
diabetes related medical devices.
[0008] According to an embodiment of the invention, a communication
system includes at least one diabetes related medical device, a
processing device, and a communication station. The communication
station includes a housing, a medical device interface, a
processing device interface and a processor. The medical device
interface is coupled to the housing and interfaces with the at
least one diabetes related medical device. The processing device
interface is coupled to the housing and interfaces with the
processing device. The processor is coupled to the housing, the
medical device interface and the processing device interface to
provide a communication path between the at least one diabetes
related medical device and the processing device so that
programming and instructions may be communicated from the
processing device to the at least one diabetes related medical
device and data may be transferred from the at least one diabetes
medical device to the processing device. In preferred embodiments,
the at least one diabetes related medical device is an infusion
pump, analyte monitor, continuous glucose monitor, glucose meter,
or the like, and the processing device is a computer. Also, in some
embodiments, the medical device interface is a cradle that is
configurable to attach to different shaped diabetes related medical
devices.
[0009] In particular embodiments, the processing device uses the
data transferred from the at least one diabetes related medical
device to generate at least one report based on the transferred
data. The at least one report includes infusion pump history and
settings, glucose meter history and settings, or both. In further
embodiments, the at least one report further includes glucose meter
with infusion pump history and glucose monitor history. The at
least one report can include tabular and graphical data, as well as
statistical analysis, exception reporting, and clinical
recommendations based on expert system analysis.
[0010] In other embodiments, the processing device interface
includes a communication circuit for communicating with the
processing device, and the processing device is a remotely located
computer. In some embodiments, the remotely controlled computer
runs software for a network data management service that utilizes
the data transferred from the at least one diabetes related medical
device.
[0011] Other features and advantages of the invention will become
apparent from the following detailed description, taken in
conjunction with the accompanying drawings which illustrate, by way
of example, various features of embodiments of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] A detailed description of embodiments of the invention will
be made with reference to the accompanying drawings, wherein like
numerals designate corresponding parts in the several figures.
[0013] FIG. 1 is a front perspective view of a communication
station in accordance with an embodiment of the present
invention.
[0014] FIG. 2 is a rear perspective view of the communication
station shown in FIG. 1.
[0015] FIG. 3 is a simplified block diagram of a communication
station for use with an infusion device, glucose monitor, glucose
meter and a personal computer in accordance with an embodiment of
the present invention.
[0016] FIG. 4 is a simplified block diagram illustrating a basic
software flow structure used by an embodiment of the present
invention.
[0017] FIG. 5 is a perspective view of an infusion pump mounted in
the cradle of the communication station shown in FIG. 1.
[0018] FIG. 6 is a perspective view of a glucose monitor mounted in
the cradle of the communication station shown in FIG. 1.
[0019] FIG. 7 is a view of a General User Preferences display
screen used by software in accordance with an embodiment of the
present invention.
[0020] FIG. 8 is a view of a Report User Preferences display screen
of used by software in accordance with an embodiment of the present
invention.
[0021] FIG. 9 is a view of a Clinic Info User Preferences display
screen of used by software in accordance with an embodiment of the
present invention.
[0022] FIG. 10 is a view of a Sensor Labels User Preferences
display screen of used by software in accordance with an embodiment
of the present invention.
[0023] FIGS. 11(a)-11(d) show views of various menus used by
software in accordance with an embodiment of the present
invention.
[0024] FIGS. 11(e)-11(s) show views of icons used as an alternative
to the menus shown in FIGS. 11(a)-11(d).
[0025] FIG. 12 is a view of a Patient Selection display screen used
by software in accordance with an embodiment of the present
invention.
[0026] FIG. 13 is a view of a Patient Entry and Edit display screen
of used by software in accordance with an embodiment of the present
invention.
[0027] FIG. 14 is a view of a Report display screen used by
software in accordance with an embodiment of the present
invention.
[0028] FIG. 15 is a view of a Current Pump Setup display screen
used by software in accordance with an embodiment of the present
invention.
[0029] FIG. 16 is a view of a Log Book display screen used by
software in accordance with an embodiment of the present
invention.
[0030] FIG. 17 is a view of a Daily Summary display screen used by
software in accordance with an embodiment of the present
invention.
[0031] FIGS. 18(a)-(c) are views of a Daily Detail display screen
used by software in accordance with an embodiment of the present
invention.
[0032] FIGS. 19(a)-(d) are views of a Weekly Summary display screen
used by software in accordance with an embodiment of the present
invention.
[0033] FIGS. 20(a)-(b) are views of a Weekly Detail display screen
used by software in accordance with an embodiment of the present
invention.
[0034] FIGS. 21(a)-(b) are views of a 2 Week Modal Day display
screen used by software in accordance with an embodiment of the
present invention.
[0035] FIGS. 22(a)-(b) are views of a Sensor Details display screen
used by software in accordance with an embodiment of the present
invention.
[0036] FIGS. 23(a)-(f) are views of legends and symbols used in the
reports generated by software in accordance with an embodiment of
the present invention.
[0037] FIG. 24 is a view of a Data Summary display screen used by
software in accordance with an embodiment of the present
invention.
[0038] FIG. 25 is a view of a Current Settings display screen used
by software in accordance with an embodiment of the present
invention.
[0039] FIG. 26 is a view of an Event Log I display screen used by
software in accordance with an embodiment of the present
invention.
[0040] FIG. 27 is a view of a Daily Log Book display screen used by
software in accordance with an embodiment of the present
invention.
[0041] FIG. 28 is a view of an Event Log II display screen used by
software in accordance with an embodiment of the present
invention.
[0042] FIG. 29 is a view of an Event Log III display screen used by
software in accordance with an embodiment of the present
invention.
[0043] FIG. 30 is a is a perspective view illustrating a
subcutaneous glucose sensor insertion set and glucose monitor
device embodying the novel features of the invention;
[0044] FIG. 31 is an enlarged longitudinal vertical section taken
generally on the line 2-2 of FIG. 30.
[0045] FIG. 32 is a simplified block diagram of a communication
station for use with an infusion device, glucose monitor, glucose
meter and a personal computer in accordance with another embodiment
of the present invention.
[0046] FIG. 33 is a simplified circuit schematic of a communication
station in accordance with yet another embodiment of the present
invention.
[0047] FIG. 34 is a generic view of an LCD for use with the
embodiment of the communication station shown in FIG. 33.
[0048] FIG. 35 is a menu screen view of an LCD for use with the
embodiment of the communication station shown in FIG. 33.
[0049] FIG. 36 is a alphanumeric screen view of an LCD for use with
the embodiment of the communication station shown in FIG. 33.
[0050] FIG. 37 is a softkey screen view of an LCD for use with the
embodiment of the communication station shown in FIG. 33.
[0051] FIG. 38 is a check screen view of an LCD for use with the
embodiment of the communication station shown in FIG. 33.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0052] As shown in the drawings for purposes of illustration, the
invention is embodied in a communication station for use with an
infusion device for infusion of a liquid, such as medication,
chemicals, enzymes, antigens, hormones, vitamins or the like, into
a body of a user; and a computer, such as a personal computer (PC),
laptop, computer, processing device, remote computer, other medical
device or the like. In preferred embodiments of the present
invention, the infusion device is an external infusion pump;
however, it will be recognized that further embodiments of the
invention may be used with programmer or data transfer devices for
use with external infusion pumps, implantable administration
devices, implantable infusion pumps, or the like, or systems that
use a combination of implantable and external components.
Particular embodiments are directed towards the use in humans;
however, in alternative embodiments, the infusion devices may be
used in animals. The invention is also embodied in a communication
station for use with a glucose monitor system that is coupled to a
sensor set to provide continuous, near continuous, or intermittent
data recording of the sensor readings for a period of time. In
preferred embodiments of the present invention, a glucose sensor
and a glucose monitor are used for determining glucose levels in
the blood and/or bodily fluids of the user. However, it will be
recognized that further embodiments of the invention may be used to
determine the levels of other analytes or agents, characteristics
or compositions, such as hormones, cholesterol, medications
concentrations, viral loads (e.g., HIV), or the like. In other
embodiments, the glucose monitor may also include the capability to
be programmed to take data at specified time intervals or
calibrated using an initial data input received from an external
device. The glucose monitor and glucose sensor are primarily
adapted for use in subcutaneous human tissue. However, still
further embodiments may be placed in other types tissue, such as
peritoneal, inter-peritoneal, intraperitoneal, dermal, sub-dermal,
subdural, intrathecal, intraventricular, muscle, lymph, organ
tissue, veins, arteries or the like, and used in animal tissue.
Embodiments may record sensor readings on an intermittent or
continuous basis.
[0053] As illustrated in FIGS. 1-3 and 32, a communication station
10 is used with an infusion pump 12 to transfer data and
information to and from a personal computer (PC) 14. In preferred
embodiments, the communication station 10 is connected to the PC 14
through a wired connection to a communication port 16. However, in
alternative embodiments, the personal computer may be connected by
a wireless connection, a computer network, by modern, or the like.
In addition, the PC 14 may be a laptop computer, another medical
device with processing capabilities, or the like. In addition, the
communication station 10 may work with devices other than an
infusion pump 12, such as sensor devices (e.g., a glucose monitor
18), glucose meter 24 or other electronic medical devices. In
addition, the communication station may be able to work with
different infusion pumps 12 and/or multiple devices at the same
time using one or more of the other ports or additional ports.
[0054] In preferred embodiments, the infusion pump 12 is connected
to the communication station 10 through a cradle holder 20 on the
communication station 10 that maintains the position and
orientation of the infusion pump 12. This permits the infusion pump
12 to interface with the communication station 10 using an optical
communication connection having optical elements 22. In alternative
embodiments, the infusion pump 12 may be connected using other
methods, such as wired connections, radio connection, contact
connections, or the like. In further embodiments, the portion of
the communication station 10 that includes the cradle 20 may be
replaceable to permit the cradle 20 to be reconfigured to work with
other medical devices, such as a glucose meter, RF programmer or
data transfer device. In still further alternative embodiments, the
optical elements may also be reconfiguarble to work with different
devices.
[0055] As shown in FIGS. 1-3, preferred embodiments of the
communication station 10 are designed to work with the MiniMed.RTM.
model 507, 507C, 508 infusion pumps and future generation infusion
pumps by allowing communication between the infusion pumps 12 and a
PC 14, laptop, remote computer, data processor, or the like. The
software, provided on diskettes or CDs with the communication
station 10, will retrieve stored infusion data from the infusion
pumps 12 and provide several reports. The reports include text,
graphics and key statistics useful for data analysis and
interpretation. The user can also download glucose measurement and
event data from the MiniMed continuous glucose monitor 18 model
MMT-7101 and 7102, and glucose meters 24 such as the Lifescan: One
Touch Profile and One Touch II, and the Roche Diagnostics:
Accu-chek complete, Accu-chek advantage, and Accu-chek easy.
However, in alternative embodiments, the communication station 10
may be used with other infusion pumps, such as those produced or
proposed by Disetronic, Animas, or the like, continuous glucose
monitors proposed by Therasense, SpectRX, or the like, and glucose
meters, such as those made or proposed by Bayer Corporation (such
as Glucometer DEX, Glucometer Elite, or the like), Abbot Medisense
(such as the Precision QID, or the like), Mercury Diagnostics, or
the like. The communication station 10 allows access to the
internal memories of the devices specified above. In preferred
embodiments, the communication station 10 and software communicates
with only one device at a time. However, in alternative
embodiments, the communication station 10 and software may
communicate with more than one device at a time.
[0056] As shown in FIGS. 3 and 32, to communicate with the infusion
pump 12 (or glucose monitor 18 or meter 24), the communication
station and software uses a combination of RS-232 and infrared
links. An RS-232 cable through port 16 connects the PC 14 to the
communication station 10 and the communication station 10 uses an
infrared communication link 22 to the infusion pump 12 (or glucose
monitor 18). The device (infusion pump 12, or glucose monitor 18)
must be placed on the communication station 10 in order for the
software to communicate with the device. To communicate with most
glucose meters 24, the communication station 10 and software uses
two RS-232 links 16 and 26. The glucose meter 24 is connected to an
additional RS-232 port 26 on the communication station 10 and the
communication station 10 merely functions as a `pass through`
connection between the PC 14 and glucose meter 24. A manually
operated switch on the communication station makes this connection.
In alternative embodiments, the switch may be automatically
activated, such as by detection of a connection with an appropriate
device or by a command generated in the PC software. The
communication station 10 will enhance communication between a
patient and a doctor by allowing the doctor to retrieve glucose
monitor data and data regarding the patient's infusion pump
usage.
[0057] As shown in FIGS. 1-3 and 32, the communication station 10
includes the following components (see FIGS. 1 and 2). an On/Off
Switch 30--The switch is marked by two symbols ".largecircle."
indicating the device is OFF and "|" indicating the device is ON. A
green light 34 illuminates when the communication station is ON. An
infusion pump "Cradle" 20--A depression in the communication
station where the infusion pump 12 (and/or glucose monitor 18) is
placed to download data stored in its memory. The cradle 20
contains infrared (IR) ports 22, which provide a communication link
between the infusion pump 12 or glucose monitor 18 and a PC 14 and
allow a data download to occur An AC Adapter Port 32--provides the
power supply connection to the communication station. Communication
Ports (Com Ports) A and B 16 and 26--using a computer cable,
provide a data link between the communication station 10 and a PC
14 (Port A--16) or a memory glucose meter 24 (Port B--26). A Device
Selector Switch 28--selects a data download from either a MiniMed
infusion pump 12 or a memory glucose meter 24 (B). A push-button or
rocker selector 28 switch will select between IR communication 22
(COM Port A connected to IR) and COM Port B 26 (COM Port A
connected COM Port B). Preferably, the PC software will not control
the selection of using either the IR port 22 or second RS-232 port
26. However, alternative embodiments may include a remote setting
switch that allows for remote selection of whether the IR port 22
or the second RS-232 port 26.
[0058] The communication station 10 shall be designed to ensure
that the IR ports 22 are insensitive to ambient light so that the
presence of ambient light will not cause a device malfunction by
interference with the IR communication transceivers 22. When
infusion pump 12 is placed in the communication station 10 cradle
20, two (2) infrared (IR) ports (not shown) on the back side of the
infusion pump 12 align with two (2) ports on the communication
station 10. Data is then transferred from the infusion pump 12
using these IR ports 22. Preferably, the communication station 10
uses at least two Infra-Red (IR) communication transceiver sets 22
on each communication station 10. One IR transceiver set 22 is
positioned to communicate with the infusion pumps 12 described
above, and the other one IR transceiver set 22 is positioned to
communicate with the glucose monitor 18.
[0059] The communication station 10 will also have two RS-232
compatible serial communication ports 16 and 26; one female DB9 (To
PC) 16, which is identified as COM Port A, and one female DB9
(pass-through) 26, which is identified as COM Port B. In preferred
embodiments, a serial cable to connect the communication station to
the PC 14 will be provided with the communication station 10. The
cable will have a female DB9 end to connect to the PC 14 and a male
DB9 end to connect to the communication station 10 (COM Port
A--16). In alternative embodiments, the male and female connectors
of the communication station and the cable may be interchanged.
[0060] The communication station 10 will use a microcontroller 34
to support the communication between the infusion pump 12 or
glucose monitor 18 and the PC 14. Preferred embodiments of the
communication station 10 software will include circuitry, modems or
the like, that supports communication at baud rates from 1024, 1200
up to 19200 Baud. However, in alternative embodiments, lower rates
to 100 Baud and higher rates to several MegaBaud may be used, with
the selection being dependent on the type, the amount of data, and
the location that the data is downloaded to.
[0061] There will be firmware (embedded software) used in the
communication station 10. This firmware will contain the means to
support communications with the infusion pump 12 or glucose monitor
18 and of translating to serial information. In preferred
embodiments, communication protocols necessary to communicate with
the infusion pump 12 or glucose monitor 18 will be contained in the
communication station 10 firmware. However, in alternative
embodiments, the communication protocols may be loaded into a RAM,
other suitable memory device, a CD, or the like.
[0062] Preferably, the communications link with the infusion pump
12 or glucose monitor 18 will not be initiated by the communication
station 10 firmware until communications with the PC software has
been established and the appropriate command has been received.
Preferably, the software to communicate to the communication
station 10 will reside in the host PC 10. However, in alternative
embodiments, the software may reside in the communication station
10, infusion pump 12, glucose monitor 18 and/or glucose meter 24.
The PC software will establish the communication link with the
communication station 10. The PC software will send the commands to
initiate the downloading of the appropriate data to a text file
which will be stored on the PC 14. It will also create reports and
graphs. In alternative embodiments, a remote computer may be
utilized to establish a communication link and may request user
confirmation at the communication station to confirm the
establishment of the communication link. The PC software will be
Windows 95-compatible. However, alternative embodiments may be
compatible with future versions of Windows, UNIX, LINUX, DOS, Mac
OS, OS2, or the like.
[0063] Preferably, the communication station shall not require any
calibration. In addition, other than periodic cleaning of the
device, no maintenance shall be required particularly in the area
of the infra-red components. It is critical to the operation of the
communication station 10 that the infra-red clear lenses protecting
the receiving and transmitting elements 22 be maintained in an
optically clear condition. The communication station 10 shall be
designed to allow cleaning with a soft cloth or paper towel and
commonly used household and clinical cleansing agents. Cleaning
requirements and chemical resistance will conform to AAMI TIR No.
12-1994 Annex A.
[0064] As shown in FIGS. 3 and 32, to use the communication station
10, connect the communication interface cable, which is supplied
with the communication station 10, into either the "COM 1" or "COM
2" connector of the PC 14. Connect the other end of the
Communication Interface Cable to the "COM A" port 16 of the
communication station 10. Connect the power cable with AC Adapter
36 into to the communication station 10 and connect the other end
to a power source. Depress the power switch 30 so that it points to
"|". A green light 34 on this switch 30 will glow when the
communication station 10 is receiving power and is turned ON. With
the connections established and power supplied, the communication
station 10 is now ready to download the data stored in the infusion
pump 12 or glucose monitor 18. Alternative embodiments may utilize
other PC communication architectures including, but not limited to,
SCSI, network, IR links, or the like.
[0065] Press the Device Selector Switch 28 on the communication
station 10 to indicate that a cradle 20 loadable device will be
used. Place the infusion pump 12 face up (so that you are looking
at the infusion pump display) into the communication station 10
cradle 20 (see FIG. 5). Make sure that the infusion pump 12 is
lying flat and snugly in the cradle 20. This will line up the IR
communication ports of the infusion pump 12 and the IR
communication ports 22 of the communication station 10. If a
glucose monitor 18 is to be used, the glucose monitor 18 is seated
in the cradle 20 (see FIG. 6). The infusion pump (or glucose
monitor 18) can now be accessed by the PC software on the PC
14.
[0066] FIG. 4 illustrates the basic system flow for the PC software
used to control the communication station 10. The software starts
with a splash screen 52 to inform the user of the software title
and version. Next the user selects either an existing patient data
file 54 or creates a new patient data file 56. After selection of
the appropriate data file, the user selects whether to download new
information 58 or to generate reports 60 based on previously
downloaded data. The following sections will discuss the various
software functions, screens and reports.
[0067] As discussed above, the software on the PC 14 will display a
Splash Screen 52 after opening the application. The Splash Screen
52 will include the following characteristics: logo, such as the
MiniMed logo, or the like; title, such as "Communications and Data
Analysis Software Version x.x", or the like; subtitle, such as "For
Use with MiniMed 507, 507C, and 508 Insulin Pumps, MiniMed Glucose
Monitor 7101 and 7102, and Glucose Meters (Accuchek, OneTouch)", or
the like; additional subtitles such as "Copyright YYYY/MiniMed
Inc./All Rights Reserved", or the like; and a button such as "OK",
or the like, to indicate an understanding of the window. In
alternative embodiments, more or less information and/or buttons
may be added to the splash screen 52.
[0068] When the user initiates the software for the first time, or
needs to reconfigure the software to reflect changes in the medical
device, patient information, or the like, the user accesses the
User Preferences Screen, as shown in FIGS. 7-10, through a menu
such as shown in FIG. 11(a). This User Preferences Screen allows
the user to setup various parameters and data for the facility and
parameters that are common to all patients. The User Preferences
screen consists of four parts, or sub-screens: General (FIG. 7),
Reports (FIG. 8), Clinic Info (FIG. 9), and Sensor Labels (FIG.
10). Additional preferences and screens may be used, with the
selection being dependent on the software requirements, the user's
needs and the type of data analysis to be performed.
[0069] As shown in FIG. 7, the General screen allows the input of:
Com Port selection (i.e. Com1, 2, 3, or 4) to use with the
communication station 10, Language Selection (American English,
Int. English, Dutch, French, German, Italian, Spanish, and Swedish)
to use for communicating with the user of the software, selection
of `Mandatory Patient ID` to identify each patient, selection of
the Patient ID Length to use with the software, and specification
of whether Patient ID is to be the patient's SSN (i.e., social
security number).
[0070] As shown in FIG. 8, the Reports screen allows the input of:
enabling of specific Quick Reports (including Current Settings,
Pump History, Daily Summary, Daily Detail, Weekly Summary, Weekly
Detail, Modal Day, & Sensor Details), specification of
Hyperglycemic and Hypoglycemic limits, and selection of the units
to be used for the meter measurements.
[0071] As shown in FIG. 9, the Clinic Info screen allows the input
of clinical information including: Clinic Name (or name of the
medical office, hospital, or the like), the Address, the physician
(or internist, endocrinologist, clinician, or the like), and the
Phone Number.
[0072] As shown in FIG. 10, the Sensor Labels screen allow the
specification of names of Sensor Labels associated with and
representative of various glucose monitor events inputted by the
user.
[0073] To use the communication PC software requires the selection
of a patient under which to download data and/or analyze data. To
select a patient, the user will click on the appropriate patient
name that is listed in a Patient Selection window, such as shown in
FIG. 12. If there is no patient, or if another patient record is
required, the user will need to create a new patient record to
associate downloaded data with that patient (or another patient
selected before downloading). FIG. 11(b) shows an example of a menu
that is used to access a Patient Entry and Edit screen.
[0074] Alternatively, the user may click on the icon in FIG. 11(e)
for a new patient or the icon of FIG. 11(f) for editing an existing
patient. FIG. 13 shows the Patient Entry & Edit screen used to
create a new patient record or edit existing information in a
patient record. The Patient Entry & Edit screen allows entry
and editing of patient name, patient ID (such as a unique number,
social security number or the like) and infusion pump type (e.g.,
brand and model number). As shown in FIG. 13, the screen also
allows entry and editing of individual patient hyperglycemic and
hypoglycemic levels, and permits the user to select glucose levels
to be displayed in either Mg/dL or mmol/L, without the necessity of
the user going to the User Preferences window. In alternative
embodiments, the Patient Entry & Edit screen may also be used
for the input of additional information, such as glucose monitor
information, glucose meter information, additional patient specific
information, or the like. Some information is inputted by typing in
the information, some by selecting from a list. In alternative
embodiments, the information may be inputted by other methods, such
as checking off selected parameters or by toggling a softkey on the
screen. If a duplicate Patient ID is entered, the PC software will
detect this and require the user to enter another ID.
Alternatively, software may determine duplication on the patient's
name, or the like.
[0075] As shown in FIG. 11(b), the software shall also allow the
user to delete individual patients and all data associated with
those patients. This is accomplished by selecting the patient from
the list shown in FIG. 12, and then selecting delete on the menu in
FIG. 11(b). Preferably, the software shall require the user to
confirm the deletion of the patient record and associated data.
Following a successful delete data operation, the specified patient
name (i.e. the patient selected on the Patient Selection screen)
will no longer appear on the Patient Selection screen. In
alternative embodiments, the information for that patient will be
maintained for possible later recall, or sent to a long term data
storage area. In that situation, to actually delete specific
information may require the use of a special screen or additional
program. In alternative embodiments, the use may select the icon
11(g) instead of the menu 11(b)
[0076] Once a patient record has been created, the Patient
Selection screen, as shown in FIG. 12, is used to specify a patient
for subsequent operations. Before a new device data can be
downloaded or before any report can be viewed, the user must first
select a patient. To select a patient from a list, the patient name
portion of the selected patient is highlighted. In addition,
subsequent edit patient, delete patient, download and report
display operations shall be for this selected patient until another
patient is selected. Preferred embodiments of the Patient Selection
screen format include the following displayed information for each
patient such as Patient name, Patient ID, Pump Type, and Date of
most recent download. The list of patients on the Patient Selection
screen is preferably sortable by any of the displayed information
such as Patient name, Patient ID, Pump Type, or Date. In
alternative embodiments, the Patient Selection screen may include
other information such as glucose monitor type, glucose meter type,
doctor, facility, or the like, and may be sortable by this
additional information. If a patient uses more than one type of
infusion pump, glucose monitor, glucose meter, or the like, so that
a patient has a history of downloads from at least two different
devices, such as both 507 and 507C infusion pumps, only the most
recently device (e.g., a 507C infusion pump) downloaded shall be
displayed on the screen.
[0077] The download operation consists of transferring data to the
PC 14 (or other data storage and/or processing device) from the
following medical devices such as infusion pumps 12, monitors 18,
and meters 24. To download data from a medical device, the user can
select the appropriate menu under the download heading shown in
FIGS. 11(a)-(d), or use the infusion pump download icon (shown in
FIG. 11(i)) to download the infusion pump 12, the glucose monitor
download icon (shown in FIG. 11(j)) to download the glucose monitor
18, or the glucose meter download icon (shown in FIG. 11(k)) to
download the glucose meter 24. The downloaded data will be saved in
the currently selected patient's record in the data base. In
alternative embodiments, the user may be able to direct the data to
be saved to a different patient record or storage area. The user
shall be notified of any download errors encountered. If possible,
the download operation will provide an error recovery capability,
which is particularly useful in conjunction with a lengthy download
operation. Preferably, during the download operation, a download
screen will be displayed with the patient name, device type and
model number. In addition, a progress bar indicator will be
displayed to indicate the status of the download. In alternative
embodiments, more or less information may be displayed. Generally,
following a successful download operation, the message "Download
completed successfully. Save data?" shall be displayed. The user is
then prompted Yes/No." The download screen will permit the user to
cancel the download operation, either during the download operation
or prior to the final saving of the data.
[0078] Downloading for infusion pumps includes the process of
transferring appropriate data from the infusion pump 12 to the PC
14. Typical stored information, which is downloaded from an
infusion pump 12 are current pump settings, daily totals and
boluses, events, and alarms. The downloaded infusion pump data is
integrated in the reports with glucose monitor 18 and glucose meter
24 data that has been previously or later downloaded (see
discussion below). The infusion pump download operation will be
initiated by either the Pump Download icon (see FIG. 11(i)) or via
the menu bar (see FIGS. 11(a)-(d)). Preferably, the infusion pump
download operation automatically determines the infusion pump model
number (e.g. 507, 507C or 508, or the like) and uses the
appropriate communication protocol for the particular infusion
pump. Generally, the transfer time runs from several seconds to 20
minutes, with the time being dependent on the type of infusion
pump, and the amount and the type of data stored in the infusion
pump. In preferred embodiments, the user will be prompted to verify
infusion pump settings following completion of the download.
Specifically, the AutoOff duration should be reset and Suspend of
the infusion pump should be canceled. In addition, after
successfully completing the download operation, the downloaded
infusion pump data will be integrated with any previously
downloaded data for the specified patient. In alternative
embodiments, the user may be given the option to replace or discard
the previous data with the newly downloaded data, or the ability to
only integrate portions of the data based on dates, times, type of
data, or the like.
[0079] The communication station PC software checks for several
differences during the download operation. For instance, the
software checks for a Time/Date difference during the download
operation by comparing the time and date in the infusion pump 12
with the time and is date in the PC 14. If a difference of >5
minutes exists, the user will be notified with a message indicating
the existence of the mismatch and the time and date for each
device. The user then will be asked to select which time and date
should be used and given the option to reset the time and date on
the infusion pump. In alternative embodiments, different time
differences may be used to prompt the user. The PC software also
checks for an infusion pump serial number difference between the
previous download, and then if noted, the software will alert the
user and offer the options of either CANCEL or PROCEED. In
addition, the software will check for a time overlap, such as by a
clock change, and then if it is noted, the program shall offer the
following options: CANCEL download, PROCEED (and discard older
overlapping data), PROCEED (and discard newer overlapping data),
Alternative embodiments may check for other differences or changes
during the download operation.
[0080] Downloading for glucose monitors 18 includes the process of
transferring appropriate data from the glucose monitor 18 to the PC
14. The glucose monitor download will be initiated from either the
Menu bar (see FIGS. 11(a)-(d)) or via the glucose monitor download
icon (see FIG. 11(j)). Typical stored information, which is
downloaded from a glucose monitor 18, includes sensor readings,
event markers, and manually entered glucose readings (e.g., for
reference and calibration). In alternative embodiments, more or
less data and information may be transferred. Generally, the
transfer time runs from several seconds to 20 minutes, with the
time being dependent on the type of glucose monitor 18, the amount
and the type of data stored in the glucose monitor 18. The glucose
monitor download operation will include an ERROR RECOVERY (the
infusion pump operation may also include this feature) which allows
the communication station software to retry the download operation
if an error is detected. In addition, after successfully completing
the download operation, the downloaded glucose monitor data will be
integrated with any previously downloaded data for the specified
patient. In alternative embodiments, the user may be given the
option to replace and/or discard the previous data with the newly
downloaded data, or the ability to only integrate portions of the
data based on dates, times, type of data, or the like.
[0081] Downloading for glucose meters 24 includes the process of
transferring appropriate data from the glucose meter 24 to the PC
14. The glucose meter download will be initiated from either the
Menu bar (see FIGS. 11(a)-(d)) or via the glucose monitor download
icon (see FIG. 11(k)). Typical stored information, which is
downloaded from a glucose meter 24, includes time stamped glucose
readings, current clock settings, event markers, or the like.
Preferably, the glucose meter download operation automatically
determines the glucose meter type and model (e.g. Roche Accuchek Vs
Johnson & Johnson One Touch, or the like) and uses the
appropriate communication protocol for the particular glucose
meter. Generally, the transfer time runs from several seconds to 20
minutes, with the time being dependent on the type of glucose
meter, the amount and the type of data stored in the glucose meter
24. In addition, after successfully completing the download
operation, the downloaded glucose meter data will be integrated
with any previously downloaded data for the specified patient. In
alternative embodiments, the user may be given the option to
replace and/or discard the previous data with the newly downloaded
data, or the ability to only integrate portions of the data based
on dates, times, type of data, or the like.
[0082] The communication station PC software provides several data
display and print options for the user to better analyze and sort
the data downloaded for each patient. For instance, the PC software
provides user-selectable displays (e.g., reports, and the like) and
printouts of infusion pump 12, glucose meter 24 and glucose monitor
18 (i.e., sensor) data in accordance with the display screens and
reports shown in FIGS. 14-29. Preferably, the user shall be
provided with the capability of selecting any display or printout
for any period prior to the last download date/time. In particular
embodiments, the selected report (display or printout) shall
contain up to 91 days of data prior to and including the selected
download date/time. Note that the report may also contain data from
a different download date and time to fill the 91 day period.
Alternatively, the report may only cover a specific period or
fraction within the downloaded data or may include more or less
than 91 days.
[0083] FIG. 14 illustrates the general display structure used by
the reports generated by the software. The report form will include
a CLOSE Command Button that undisplays (removes) the individual
report when the user is done with that report. The report form will
display a Help menu to provide context-sensitive help for the
selected report (see FIG. 11(d)). If the report includes more than
one screen, arrow buttons (generally located at the bottom of the
screen) will provide for moving back and forth between the multiple
screens.
[0084] A report is selected for display via either the standard
Windows menu (e.g. under reports--see FIG. 11(c)) or via the
communication station 10 toolbar (using report icons--see FIGS.
11(1)-11(s)). The active-inactive state of a toolbar icon is
context sensitive to the patient's specific infusion pump type,
glucose monitor type, and glucose meter type. Accordingly, some
Report Icons (and menu selection options) are inactive for some
infusion pumps, glucose monitors and glucose meters. It should be
noted that additional reports may be generated, with the following
reports serving to illustrate various reporting abilities. During
the report generation process, the following labels (see FIG.
23(a)) may be used to express various data status issues:
`Inc`=incomplete data (there is some data but it is clear that some
data is missing); `N`=no data is present; `T`=a time change has
occurred w/o overlap; and `O`=a time change has occurred with
overlap. In addition, where appropriate, the x-axis shall be
displayed in either a 12 or 24 hour format depending on the User
Preference screen setting. FIG. 14 illustrates and describes
various other aspects of the general report screen. Although not
shown in these reports, the reports may also include facility
information such as Physician Name, Address (facility), and Phone
Number (facility).
[0085] FIG. 15 illustrates the Patient Information/Current Pump
Settings Report, which is selectable by the icon shown in FIG.
11(l). This report will have the following components: [0086] 1)
the Device Table section lists the devices that have been
previously downloaded into the selected patient's file. The table
includes for each previously downloaded device: the device name,
serial number, and most recent download date. The devices listed in
the Device Table shall be: infusion pump(s), monitor(s), and
meter(s). For each device type (e.g. infusion pump), there may be
either none, one, or multiple instances listed. Preferably, this
section of the report shall be of variable length and shall be
scrollable. If infusion pump data is present, the infusion pump
settings listed in report shall be displayed at the bottom of the
report. If multiple infusion pumps are listed, the settings of only
the infusion pump most recently used shall be displayed. [0087] 2)
the Current Basal Profile section, if infusion pump data is
present, will show the current 24 hour Basal Profile as a
continuous line and/or bar graph over 24 hours. Units/hour shall be
depicted on the Y axis, with the values preferably automatically
scaled with the highest value equal to the next highest whole unit
above the highest basal rate setting. In addition, it is preferred
that the time in hours will be depicted on the x axis with 12 am, 3
am, 6 am 9 am, 12 noon, 3 pm 6 pm, 9 pm and 12 am markers
indicated. Also, faint horizontal lines will be present across the
graph at 0.2 unit increments up to a maximum of 5.0 units/hour. If
the total exceeds 5.0 units, the scale will switch to 0.5 unit
increments. Other units, time values or axis labeling may be used.
[0088] 3) statistics on the profile will also be provided and
include the number of basal rates (rates/day), the total basal
insulin (U/day), the date the basal rate was last changed (date),
and the umber of days since the profile was changed.
[0089] The software shall have the ability to display Current
Infusion Pump Setup information as shown in Table 1 below:
TABLE-US-00001 TABLE 1 Pump Setting Display Format Parameter Units
Range Auto Off Hr--Hour Off, Hour setting Beep Volume N/A 1, 2, 3
Audio Bolus U--Units Off, or `increment step level` Variable Bolus
N/A On, Off Max Bolus U--Units 0.0-25.0 Units Max Basal U/H--Units
per hour 0.0-35.0 Units per hour Time Display N/A 12 Hr, 24 Hr
Insulin N/A U40, U50, U100 Concentration
[0090] FIG. 16 illustrates the Log Book report, which is selectable
by the icon shown in FIG. 11(m). This is a chronological report
that integrates infusion pump 12, glucose monitor 18, and glucose
meter 24 data. The report will provide a vertically scrolling table
with 3 columns (Date-Time of data entry, Item explaining data, and
Value of data) for a user specified period. Generally, this is for
the most recent 91 days of data in descending order; however,
longer or shorter periods may be used. The user may tailor the
content using the check boxes listed on the side of the report, and
which are segregated by Pump, Meter and Sensor (or Monitor). Check
boxes shall be provided to allow the user to select any combination
of the following items to display in the table: Pump Data includes
bolus history, prime history, daily insulin totals, alarms,
programming events, and basal profile changes; Glucose Meter data
includes glucose measurements and excursions; and glucose monitor
data includes sensor data, sensor summary (mean, minimum and
maximum for each hour of sensor use), sensor excursions (all sensor
values outside limits hourly sensor summary defined in the User
Preferences screen), sensor data (every sensor reading, at 5 min
intervals), sensor event markers (with labels as defined in
specified patient User Preferences screen). In alternative
embodiments, other parameters may be provided and selected.
[0091] FIG. 17 illustrates the Daily Summary report screen, which
is selectable by the icon shown in FIG. 11(n). This report provides
a summary of information relating to the glucose data status and
insulin data status for a particular day. Alternatively, it may
provide a report for several days in a summary format as shown. The
glucose data status section shows the number of readings, the
average glucose value and the range. The insulin data status
section shows total amount of insulin taken, the number of boluses,
the prime volume, the percent of the time that a temporary basal
rate was used, and the percent of time that the infusion pump
operation was suspended. This report is similar to the report shown
in FIGS. 19(a)-(d) below, but summarizes on a daily basis rather
than a weekly basis.
[0092] FIGS. 18(a)-(c) illustrate the Daily Details report screen,
which is selectable by the icon shown in FIG. 11(o). This report
provides a detailed daily view of each of up to 91 days of infusion
pump, glucose meter, and sensor (e.g., monitor) data. Each screen
represents a single day's data and consists of the following
components: infusion pump data (i.e., insulin usage data), sensor
and meter data (i.e., glucose data), alamm/event/marker table, and
pie charts (basal:bolus ratio and bolus type).
[0093] The infusion pump data is shown in the upper section and
graphically depicts basal rate, bolus, prime, and alarm history for
the specified day. The basal rate is shown as a line indicating:
normal basal rate, temporary basal rate, auto-off, and suspend
(preferably, the programmed normal basal rate shall be shown as a
dashed line during any of: suspend, temporary basal rate, or
auto-off). Boluses will also be indicated. The alarm markers will
be positioned to show the time of any alarm. In the illustrated
report, two insulin scales are marked due to the relative scale of
a bolus (large) compared to a basal rate (small). The bolus scale
shall be on the left y-axis and the basal scale shall be on the
right hand y-axis. In particular embodiments, any priming events
will also be shown.
[0094] The sensor and meter data is shown in the lower section and
graphically depicts meter readings and sensor data-vs.-time for the
specified day. Preferably, any continuous glucose monitor (i.e.,
sensor) readings will be displayed as a continuous line graph.
Meter readings will be marked as either a reference value or as
calibration points. Any sensor event markers, such as small
rectangular markers, or the like, at the bottom edge shall depict
sensor event markers.
[0095] The alarm/event/marker table is shown in an upper side
section and will be shown only if either infusion pump 12, glucose
meter 24 or glucose monitor 18 (i.e., sensor) data is present.
Alarms and events from the infusion pump 12, glucose meter 24 and
glucose monitor 18 will be listed in order of time of the
event/alarm. Textual definitions for events shall be listed if
defined; otherwise a numeric value for the events shall be shown.
This table shall display the following `programming changes` for
the current day: Time/Date change--displays new date (in mm-dd-yy
format) and new time, where the time change is displayed in either
12 or 24 hr format depending on user's settings; Suspend
On/Off--time the feature was turned on and was time turned off;
Temporary basal rate--displays setting of a Temporary Basal Rate
including amount in units per hour (e.g. 0.6 u/h) and duration
displayed in same format as duration for bolus history; Basal Rate
change--a note referring to a Basal Profile section for basal rate
change history; battery removal/replacement--displays the removal
and subsequent replacement of batteries with time of action;
Maximum Basal Rate change--changes of the setting along with the
time of action; Maximum Bolus change--displays the change of
setting along with the time of action; Insulin Concentration
change--displays the change of concentration; Auto Off
Change--displays new feature setting along with the time of change
displayed in hours; Alarm/Error Code--brief description of the
alarm/error.
[0096] The pie chart data is shown in a lower side section and
graphically depicts basal:bolus ratio and bolus type as pie
charts.
[0097] FIGS. 19(a)-(d) illustrate the Weekly Summary report, which
is selectable by the icon shown in FIG. 11(p). This report provides
13 weekly summaries of meter and pump data followed by a 91 day
summary of the entire period. Each weekly column is composed of 2
vertical sections: Monitor and Meter Data (Glucose Data Status) and
Infusion Pump Data (Insulin Data Status) using both tabular and
graphical formats. As discussed above, this report is similar to
the Daily Summary report shown in FIG. 16.
[0098] The Weekly Summary report is be split between two screens
with 7 weeks on the first screen and 6 weeks on the second screen.
In addition, a 91 day summary column will follow the 13th week on
the second screen. Preferably, the report will arrange data and
graphics into a table format with one row for each data category
and one column for each week. The most recent week's data (i.e.
`column`) shall be on the left with prior weeks to the right. In
alternative embodiments, other data formats or orders of
presentation may be used.
[0099] Each week's data (i.e. column) shall consist of: [0100] 1)
tabular monitor and/or meter data including the average number of
meter readings per day (numeric); glucose goals (numeric): percent
that are above the hyperglycemic limit, percent that are in range,
and percent that are below hypoglycemic limit (as set in the User
Preferences screen); standard deviation of the week's meter
readings (numeric); average glucose value (i.e. the average meter
reading) (numeric); and a graphic component that shows the glucose
reading range (e.g., a narrow vertical rectangle), average glucose
value (e.g., a diamond within the rectangle), and the hyperglycemic
and hypoglycemic limits (e.g., shown as 2 dotted horizontal lines).
In alternative embodiments, other data formats or orders of
presentation may be used. [0101] 2) Tabular infusion pump data
including the average Daily total insulin (numeric); average number
of boluses per day (numeric); average prime volume (numeric); the
percent of the time that a Temporary Basal rate is used (numeric);
the percent of the time that the infusion pump was in the Suspend
mode (numeric); and a graphical component including total insulin,
basal insulin, bolus insulin in a stacked column chart, with basal
amount on the bottom including the percent of insulin delivered by
basal rate (numeric), and the graphic also shows the average daily
total insulin for the 13 week period as a horizontal dotted line
with associated numeric value. In alternative embodiments, other
data formats or orders of presentation may be used.
[0102] FIGS. 20(a)-(b) illustrate the Weekly Details report, which
is selectable by the icon shown in FIG. 11(q). This report provides
a 14 day graphical view of infusion pump data (bolus & primes)
and glucose meter (but not sensor) readings. The screen is split
evenly between 2 screens with 7 days on each screen, and each
screen having a first row with 4 days and a second row with 3 days.
Data and graphics are arranged in a table format with one row for
each data category (e.g. infusion pump boluses and primes, or
glucose meter data) and one column for each day. Additionally, pie
charts of infusion pump and glucose meter data are displayed. In
alternative embodiments, glucose monitor (sensor) data may be
included, and/or a legend explaining the symbols used may be
provided on the screen. Preferably, the most recent date (e.g.,
column) shall be on the left with prior dates to the right.
[0103] The infusion pump data includes the boluses and primes
covering a 14 day period. Generally, the basal profile is not
included since this is not changed frequently, but alternative
embodiments could include it as part of the report. The data should
include an insulin scale that is marked in units, and each bolus
and prime should be indicated against this scale.
[0104] The glucose meter data is a plot of meter readings that
covers the specified 14 day period. Preferably, the readings are
plotted against a glucose scale of 20 to 240 (although other limits
may be used). The hyperglycemic and hypoglycemic limits (set in the
User Preferences screen) will be displayed as horizontal dotted
lines. In particular embodiments, the numeric values of the limits
shall be displayed adjacent to the lines. Any off the scale
readings, such as those greater than 240 will be indicated at the
upper edge of the Meter Data graph by a `triangle` and a numeric
value.
[0105] The pie charts will include 3 pie charts that each covers 7
days of infusion pump and glucose meter data. The Glucose Goals
chart includes three sections that show the percentage of glucose
meter readings that were above, within, and below range. The
Basal/Bolus ratio chart includes two sections that shows the
percentage of total basal insulin and total bolus insulin. The
Bolus Type chart includes two sections that show the percentage of
bolus volume that was delivered by a Normal Bolus and a Square Wave
Bolus volume. In preferred embodiments, any dual boluses are split
into the Normal Bolus and Square Wave Bolus components. However, in
alternative embodiments, the dual boluses may be included as a
separate section of the pie chart.
[0106] FIGS. 21(a)-(b) illustrate the 2 Week Modal Day report,
which is selectable by the icon shown in FIG. 11(r), This report
provides the glucose meter data from a specified 14 days so that it
is plotted vs. time on a single day scale so that a user may
visualize trends over 2 week period as it relates to specific times
of day. The user also has the option of connecting all of the data
from the same day using a connecting line. In addition, to aid in
understanding the data, each day's data (i.e. multiple points)
shall have a unique color, and any connecting lines (when present)
shall also be color coded to match the colors of points. The
hypoglycemic and hyperglycemic limits (set in the User Preferences
screen) will be shown as horizontal dotted lines. Also, the 14 day
mean value of meter readings shall be shown as a horizontal dotted
line.
[0107] The 2 Week Modal Day report will also have a tabular
Statistical Data section that will include the date range (e.g.,
the total span of dates displayed), number of days displayed, Mean
Glucose Level for the selected period, Standard Deviation of the
glucose meter readings, Average number of meter readings per day.
The 2 Week Modal Day report will also include a Glucose Goals pie
chart having three sections that show the percentage of glucose
meter readings that were above, within, and below range for the
selected period.
[0108] FIGS. 22(a)-(b) illustrate the Sensor Details report, which
is selectable by the icon shown in FIG. 11(s). This report depicts
Glucose Monitor data (including meter calibration & reference
data) for the specified 4 day period. The report includes the
following components: 1) Continuous Glucose Measurement data
(preferably, displayed on a 4 day time scale.), Modal Day display
of Glucose Monitor data displayed on a 24 hour scale. In preferred
embodiments, the four days of data immediately prior to (and
including) the specified download date will be displayed. However,
in alternative embodiments, the user may specify other time
periods. Preferably, calibration and reference data points will be
integrated with the sensor data and will be differentiated by
`point style` (i.e. shape of the `dot`). Also, each day's sensor
data will be uniquely colored, and a specific day's color in the
`Sensor Data` section will match the corresponding day color in the
`Modal Day` graph section. In addition, the hypoglycemic and
hyperglycemic glucose limits (set in the User Preferences screen)
will be indicated as dashed lines.
[0109] The top portion of the report includes the Sensor Data
section that displays a 4 day continuous graph of Glucose Monitor
data integrated with meter calibration and reference points. The
bottom portion of the report includes the Modal Day section that
displays the Sensor data for the specified 4 day period so that it
is plotted vs. time on a single day scale (i.e., 4 continuous line
graphs of sensor data shall be overlaid on a single day time
scale). The bottom side portion includes a Glucose Goals pie chart
that has three sections that show the percentage of glucose meter
readings that were above, within, and below range for the selected
4 day period. The bottom side portion also has a tabular
statistical data section that will include the Hours of Sensor data
displayed, the Mean Glucose Level for the selected period, the
Maximum and Minimum Glucose level for the selected period, the
Standard Deviation of the glucose Sensor data, and the average
number of meter readings per day.
[0110] As shown in FIGS. 23(a)-(f) various legends, symbols and
color codes may be utilized on the reports. In particular
embodiments, the symbols and color codes may be displayed on the
report as a legend to define the graphical elements used on the
report screen. They are also provided here to further define and
clarify the material shown in the reports described herein.
[0111] As described above, the reports are generated and displayed
by the communication station PC software used by the PC 14 to
interpret the data downloaded from a medical device through the
communication station 10 to the PC 14. However, the displayed
reports may also be printed out for hard copy records or analysis,
such as by the use of a menu or by selecting the icon shown in FIG.
11(h). Preferably, either a single report or multiple reports may
be printed. In some embodiments, the reports may be faxed or
E-mailed to a different location for review by a patient,
physician, insurance company, or the like. In preferred
embodiments, when the `Quick Reports` operation is initiated under
the menu shown in FIG. 11(c), the reports previously specified in
the User Preferences screen will be printed.
[0112] FIGS. 24-29 illustrate alternative report screens that can
be accessed using other embodiments of the communication station PC
software. Many of the reports provide information that is similar
to that provided above, but it is presented in different style or
format to illustrate some of the possible variations that are
available in the report screens. The embodiment includes a Main
Screen (not shown) that allows selection of the various reports.
This embodiment includes the following reports: Summary--displays
infusion pump summary data; Current Settings--displays the current
infusion pump settings and basal profile; Daily Log--displays a
daily log book of patient data; Event Log I--displays the bolus
history, daily totals, and prime history logs; Event Log
II--displays the programming events, alarm and basal rate change
history logs; and Event Log III--displays the complete infusion
pump history log. The Main Screen also includes a Print Screens
button that prints the selected reports.
[0113] For these embodiments, each report will have three button
options on the bottom of each screen: Main Screen--a single click
on this button will return the user to the main screen to select
another report; Print Screen--a single click on this button will
print the current report; and Help--a single click on this button
will pull up the help files.
[0114] FIG. 24 illustrates the Data Summary report which has 5 main
sections: the Bolus History section displays the average bolus, the
minimum bolus, the maximum bolus and the average number of boluses
given per day for three different time buckets (e.g., 7 days, 30
days and 90 days). The Basal Rate History section displays the
average basal total (i.e., the total amount delivered over a 24
hour period), the average basal rate (i.e., the average basal rate
delivered per hour), the percent of the time the infusion pump was
suspended and the percent of the time spent in a temporary basal
rate for the same three time buckets listed under the Bolus
History. The Daily Total History section displays the average daily
total of insulin delivered, the average daily rate for insulin
delivered, the minimum daily total for insulin delivered, and the
maximum daily total of insulin delivered for the three different
time buckets listed under the Bolus History. The Daily Total Graph
section is a bar graph which shows the total amount of insulin
delivered over the past 14 days. The bars are "stacked" to show the
amount of insulin delivered by basal rate delivery (e.g., bottom of
bar) and the amount of insulin delivered by bolus delivery (top of
bar). Underneath each bar the date is displayed, and the insulin
scale is to the left of the graph in units (preferably, these
values scale automatically to match the amount that the user has
delivered). The Basal/Bolus Ratio Graphs are made up of three pie
charts which show the percent ratio of Bolus delivery vs. Basal
Rate delivery for three time periods. Graph one shows this ratio
for the last seven (7) days, graph two for thirty (30) days, and
graph three for ninety (90) days. The ratio appears in text
adjacent to each of the sub-sets in the graph. When looking at
reports that display averages for time buckets, if there is not
enough data to complete a time bucket, for example if only 35 days
worth of data is stored in the infusion pump, or the downloaded
data, no data will be displayed for 90 days bucket. Alternative
embodiments will allow the selection of different time periods to
be analyzed.
[0115] FIG. 25 illustrates the Current Setting report which has two
main components: a listing of the current infusion pump settings
and a graph of the current basal profile. The current infusion pump
settings includes information on: Auto Off (OFF or the hour setting
if on, e.g. 10 hr); Beep Volume (setting level 1, 2 or 3); Audio
Bolus (OFF or increment step level either 0.5 or 1.0 units);
Variable Bolus (OFF/ON); Maximum Bolus (0-25 unit setting in
units); Maximum Basal rate (0-35 unit setting in units/hour); Time
Display (12 or 24 hr); and Insulin Concentration (U100, U50, U40).
The current basal profile graph is a continuous bar graph over a 24
hour period. Insulin amounts are shown to the left of the graph in
units/hour (preferably, these values automatically scale to adjust
to the individual's basal rate and the highest value is equal to
the next highest whole unit above the user's highest basal rate
setting). The time in hours is depicted across the bottom of the
graph 12 am, 3 am, 6 am, 9 am, 12 noon, 3 pm, 6 pm, 9 pm and 12 am
markers indicated (if the infusion pump is set in 24 hour format,
the graph will show 24 hour markers). Faint horizontal lines are
present across the graph at 0.2 unit increments up to a maximum of
5.0 units/hour. If the total exceeds 5.0 units the scale switches
to 0.5 unit increments. The graph's header contains the title
"Current Basal Profile" as well as the 24 hour basal total and the
number of basal rates currently being used.
[0116] FIG. 27 illustrates the Daily Log Book report that allows
the user to review the infusion pump's operation by date. The
report displays the following information. Bolus History, Basal
Profile, Programming Events, Alarms, Primes and the Daily Total for
insulin. [0117] Bolus History is table that displays the time,
type, amount, and duration of the day's bolus deliveries in
chronological order. The boluses are listed as N for Normal, S for
Square, D/N for the Normal portion of a Dual Wave Bolus, and D/S
for the Square Wave portion of a Dual Wave Bolus. Bolus amounts are
recorded in units, e.g. 6.0 units. Duration times for Square and
Dual Wave boluses are displayed using the following format: a one
hour bolus would be shown as 1:00, a 2 and a 1/2 hour bolus is
shown as 2:30. [0118] Basal Profile is a table that displays the
current basal rates set in the pump and the times which each rate
starts for the current day. [0119] Programming Events is a table
that displays all the programming changes for the current day
beginning at 12:00 am. The possible programming changes include:
Time/Date Change--displays new date (in mm-dd-yy format) and new
time and time of change (a Time change is displayed in both 12 and
24 hour format depending on the User Preferences). Suspend
ON/OFF--displays the time when Suspend feature was first turned on
and then turned off. Temporary basal rate--displays a setting of a
temporary basal rate including amount in units per hour, e.g. 0.6
U/h, as well as time, and duration of the temporary basal rate.
Basal rate change--displays a note referring to Log II to review
basal rate changes. Battery removal/replacement--displays the
removal and replacement of batteries with the time of action.
Maximum basal rate change--displays the change of setting with the
time of action. Maximum bolus change--displays the change of
setting with the time of action. Insulin Concentration
change--displays the change of concentration with the time of
action. Auto Off Change--displays setting along with the time of
change displayed in hours. [0120] Alarms is a table that displays
the time, alarm/error code and a brief description of any alarm
received for the current 24 hour period. The following alarms are
the most common alarms that the user may see: A-04--No Delivery;
A-05--Depleted Batteries; A-06--Auto Off; A-35--Motion Sensor; and
A-51--Watchdog. Alternative embodiments may display more or less
alarms. [0121] Prime History is a table that displays the time and
prime amount in units for the current day. Daily Total is an area
that displays the current day's total insulin delivered as a Basal
and Bolus in units, e.g. 60.0 units as of the time of the download.
To select a different date to review, the user clicks the "Select
Date" softkey button and clicks on the desired date.
[0122] FIG. 26 illustrates the Event Log I report that includes
three scrollable tables: Bolus History table that shows the date,
time, type, amount and duration of all the boluses stored in the
infusion pump (The average daily total for the boluses shall be
displayed under the Bolus History table); Daily Total History table
that displays the date and the total amount of insulin delivered as
basal rate plus boluses for up to 90 days (the average daily total
of insulin shall be displayed under the Daily Total table); and
Prime History table that displays the date, amount and time for up
to 50 primes.
[0123] FIG. 28 illustrates the Event Log II report, which includes
three tables: the Programming Event history, the Alarm History, and
the Basal Rate Change history. Programming Event History--displays
the date, time and type of up to 200 programming events. Alarm
History--displays the date, time and type up to 50 alarms and error
codes. Basal Rate Change History--displays a listing of basal rate
changes that have occurred including the complete basal profile
with date, time and setting changes. If no basal changes have
occurred, no data is displayed.
[0124] FIG. 29 illustrates the Event Log III report, which lists
all of the infusion pump operations in reverse chronological order
for the past 90 days. The last listing for each day is a daily
insulin total.
[0125] Various modifications may be made to these reports, and they
may be combined together in different ways to create custom reports
that are suited to the user's needs. Although various color and
graphical schemes have been presented, other schemes are possible
without departing from the scope of the embodiments of the present
invention. The reports have emphasized the use of a communication
station 10 with an infusion pump 12 and augmenting the data with
data from a glucose meter 24 and/or glucose monitor 18. However,
the communication station 10 and PC software may be used with other
medical devices, which then place particular emphasis on data from
these devices. For instance, the communication station 10 may be
used primarily with a glucose monitor 18 and provide expanded
reports beyond those described above. The reports may report
additional histories and events similar to those described above
for the infusion pump 12 or in a manner that are particularly
suited to the analysis requirements of the glucose monitor 18 and
its data.
[0126] In that view, as illustrated in FIG. 6, a communication
station 10 may used with a glucose monitor 18 to transfer data and
information to and from a personal computer (PC) 14. In preferred
embodiments, the communication station 10 is connected to the PC 14
through a wired connection 16. However, in alternative embodiments,
the PC 14 may be connected by a wireless connection, a computer
network, by modem, or the like. In addition, the PC 14 may be a
laptop computer, another medical device with processing
capabilities, or the like. In preferred embodiments, the glucose
monitor 18 is connected to the communication station 10 through a
cradle holder 20 on the communication station 10 that maintains the
position and orientation of the glucose monitor 18. This permits
the glucose monitor 18 to interface with the communication station
10 using an optical communication connection having optical
elements 22. In alternative embodiments, the glucose monitor 18 may
be connected using other methods, such as wired connections, radio
connection, contact connections, or the like.
[0127] The glucose monitor system 1001, in accordance with a
preferred embodiments of the present invention include a sensor set
1010, and a glucose monitor 18. The sensor set 1010 utilizes an
electrode-type sensor 1012, as described in more detail below.
However, in alternative embodiments, the sensor may use other types
of sensors, such as chemical based, optical based or the like. In
further alternative embodiments, the sensors may be of a type that
is used on the external surface of the skin or placed below the
skin layer of the user. Preferred embodiments of a surface mounted
glucose sensor would utilize interstitial fluid harvested from the
skin. Preferably, the sensor 1012 monitors blood glucose levels,
and may be used in conjunction with automated or semi-automated
medication infusion pumps of the external or implantable type as
described in U.S. Pat. No. 4,562,751; 4,678,408; 4,685,903 or
4,573,994, to deliver insulin to a diabetic patient. However, other
embodiments may monitor other analytes to determine viral load, HIV
activity, bacterial levels, cholesterol levels, medication levels,
or the like.
[0128] The glucose monitor 18 generally includes the capability to
record and store data as it is received from the glucose sensor
1010, and then includes either a data port or wireless transmitter
for downloading the data to a PC 14, a data processor 200, laptop,
communication station, or the like for later analysis and review.
The PC 14, data processor 200, laptop, or the like, utilizes the
recorded data from the glucose monitor to determine the blood
glucose history. The purpose of the glucose monitor system 1001 is
to provide for better data recording and testing for various
patient conditions utilizing continuous or near continuous data
recording.
[0129] Logged data can be analyzed further for detailed data
analysis. In further embodiments, the glucose monitor system 1001
may be used in a hospital environment or the like. Still further
embodiments of the present invention may include one or more
buttons 1122, 1124, 1126 and 1128 on the glucose monitor 18 to
program the monitor 18, to record data and events for later
analysis, correlation, or the like. In addition, the glucose
monitor may include an on/off button 1130 for compliance with
safety standards and regulations to temporarily suspend
transmissions or recording. The glucose monitor 18 may also be
combined with other medical devices to combine other patient data
through a common data network and telemetry system. In alternative
embodiments, the glucose monitor 18 may be designed as a
Holter-type system that includes a Holter-type recorder that
interfaces with a glucose monitor, processor, computer of the like,
such as disclosed in U.S. patent application Ser. No. 09/246,661
filed Feb. 5, 1999 and entitled "An Analyte Sensor and Holter-Type
Monitor System and Method of Using the Same", which is herein
incorporated by reference. Further embodiments may use wireless
communication between the sensor set 1010 and the glucose monitor
18 utilizing a telemetered glucose monitor transmitter as shown and
described in U.S. patent application Ser. No. 09/377,472, filed
Aug. 19, 1999 and entitled "Telemetered Characteristic Monitor
System and Method of Making the same", which is herein incorporated
by reference.
[0130] As shown in FIGS. 30 and 31, a sensor set 1010 is provided
for placement of a flexible sensor 1012 (see FIG. 31), or the like,
at a selected site in the body of a user. The sensor set 1010
includes a hollow, slotted insertion needle 1014, and a cannula
1016. The needle 1014 is used to facilitate placement of the
cannula 1016 at the insertion site. The cannula 1016 includes a
sensing portion 1018 of the sensor 1012 to expose one or more
sensor electrodes 1020 to the user's bodily fluids through a window
1022 formed in the cannula 1016. After insertion, the insertion
needle 1014 is withdrawn to leave the cannula 1016 with the sensing
portion 1018 and the sensor electrodes 1020 in place at the
selected insertion site.
[0131] Further description of flexible thin film sensors of this
general type are be found in U.S. Pat. No. 5,391,250, entitled
METHOD OF FABRICATING THIN FILM SENSORS, which is herein
incorporated by reference. The connection portion 1024 may be
conveniently connected electrically to the sensor monitor (not
shown), a glucose monitor 18, or a data processor 200, computer,
communication station, or the like, by a connector block 1028 (or
the like) as shown and described in U.S. Pat. No. 5,482,473,
entitled FLEX CIRCUIT CONNECTOR, which is also herein incorporated
by reference.
[0132] The sensor 1012 is mounted in a mounting base 1030 adapted
for placement onto the skin of a user. As shown, the mounting base
1030 is a generally rectangular pad having an underside surface
coated with a suitable pressure sensitive adhesive layer 1032, with
a peel-off paper strip 1034 normally provided to cover and protect
the adhesive layer 1032, until the sensor set 1010 is ready for
use. As shown in FIG. 32, the mounting base 1030 includes upper and
lower layers 1036 and 1038, with the connection portion 1024 of the
flexible sensor 1012 being sandwiched between the layers 1036 and
1038. The connection portion 1024 has a forward section joined to
the sensing portion 1018 of the sensor 1012, which is folded
angularly to extend downwardly through a bore 1040 formed in the
lower base layer 1038.
[0133] The insertion needle 1014 is adapted for slide-fit reception
through a needle port 1042 formed in the upper base layer 1036 and
further through the lower bore 1040 in the lower base layer 1038.
As shown, the insertion needle 1014 has a sharpened tip 1044 and an
open slot 1046 which extends longitudinally from the tip 1044 at
the underside of the needle 1014 to a position at least within the
bore 1040 in the lower base layer 1036. Above the mounting base
1030, the insertion needle 1014 may have a full round
cross-sectional shape, and may be closed off at a rear end of the
needle 1014. Further description of the needle 1014 and the sensor
set 1010 are found in U.S. Pat. No. 5,586,553, entitled
"TRANSCUTANEOUS SENSOR INSERTION SET" and co-pending U.S. patent
application Ser. No. 09/346,835, entitled `DISPOSABLE SENSOR
INSERTION ASSEMBLY," which are herein incorporated by
reference.
[0134] The cannula 1016 is best shown in FIGS. 30 and 31, and
includes a first portion 1048 having partly-circular cross-section
to fit within the insertion needle 1014 that extends downwardly
from the mounting base 1030. In alternative embodiments, the first
portion 1048 may be formed with a solid core; rather than a hollow
core. In preferred embodiments, the cannula 1016 is constructed
from a suitable medical grade plastic or elastomer, such as
polytetrafluoroethylene, silicone, or the like. The cannula 1016
also defines an open lumen 1050 in a second portion 1052 for
receiving, protecting and guideably supporting the sensing portion
1018 of the sensor 1012.
[0135] As shown in FIGS. 30 and 31, the glucose monitor 18 is
coupled to a sensor set 1010 by a cable 1102 through a connector
1104 that is electrically coupled to the connector block 1028 of
the connector portion 1024 of the sensor set 1010. In preferred
embodiments, the plug connector 1103 of the cable 1102 is connected
to the glucose monitor 18 through a plug receptacle 1105. In
alternative embodiments, the cable 1102 may be omitted, and the
glucose monitor 100 may include an appropriate connector (not
shown) for direct connection to the connector portion 1024 of the
subcutaneous glucose sensor set 1010 or the subcutaneous glucose
sensor set 1010 may be modified to have the connector portion 1024
positioned at a different location, such as for example, the top of
the subcutaneous sensor set 1010 to facilitate placement of the
glucose monitor 18 over the sensor set 1010.
[0136] The glucose monitor 18 includes a housing 1106 that supports
a printed circuit board 1108, batteries 1110, memory storage 1112,
the cable 1102 with the plug connector 1103, and the plug
receptacle 1105. In preferred embodiments, the housing 1106 is
formed from an upper case 1114 and a lower case 1116 that are
sealed with an ultrasonic weld to form a waterproof (or resistant)
seal to permit cleaning by immersion (or swabbing) with water,
cleaners, alcohol or the like. As shown, the lower case 1116 may
have an underside surface that includes a belt clip 1118 (or the
like) to attach to a user's clothing.
[0137] As shown in FIG. 31, the PC 14, data processor 200,
computer, communication station 10, or the like, may include a
display 214 that is used to display the results of the measurement
received from the sensor 1018 in the glucose sensor set 1010
received via a download from the glucose monitor 18. The results
and information displayed includes, but is not limited to, trending
information of the characteristic (e.g., rate of change of
glucose), graphs of historical data, average characteristic levels
(e.g., glucose), or the like. Alternative embodiments include the
ability to scroll through the data. The display 214 may also be
used with buttons (not shown) on the PC 14, data processor 200,
laptop, communication station 10, or the like, to program or update
data in the data processor 200 or PC 14. In preferred embodiments,
the glucose monitor 18 includes a display 1132 to assist the user
in programming the glucose monitor 18, entering data, stabilizing,
calibrating, downloading data, or the like.
[0138] After a sensor set 1010 has been used for a period of time,
it is replaced. The user will disconnect the glucose sensor set
1010 from the cable 1102 and glucose monitor 18. In preferred
embodiments, if an additional test is required and/or desired, the
glucose monitor 18 is connected to a new sensor set 1010. A new
sensor set 1010 and sensor 1012 are attached to the glucose monitor
18 and connected to the user's body. Recording then continues, as
with the previous sensor 1012. Finally, the data stored in the
memory 1112 of the glucose monitor 18 is downloaded (or
transmitted) to the PC 14, data processor 200, laptop,
communication station 10, or the like, for analysis and review.
[0139] FIG. 32 shows a simplified block diagram of the
communication station 10 shown in FIGS. 1-3 and described above.
However, FIG. 33 shows a simplified circuit schematic of another
embodiment of a communication station 500 that can be used with the
medical devices described above. The communication station 500
shown FIG. 33 includes several improvements that increase the
utility and capabilities of the communication station 500 to store
and transmit data for later analysis by the software in the PC 14.
The communication station 500, like the communication station 10
above, will communicate with infusion pumps 12, glucose monitors
18, and blood glucose meters 24 that have the capability of
communicating over an RS-232 serial port 26. In addition to
interfaces for the devices mentioned above, the communication
station 500, like the communication station 10 above, will also
incorporate a RS-232 serial port 16 for communication with a PC 14
or other local device. However, the communication station 500 will
also include a modem 502 and a telephone interface for
communication with a network-based information management service,
such as is described in U.S. Patent Application Ser. No. 60/143,981
filed May 20, 1999 and entitled "Diabetes Integrated Management
System", which is herein incorporated by reference. Reports similar
to those described above may be generated by the network based
information management service. Alternative embodiments may utilize
other telecommunication architectures to connect with the network
based information management service, such as DSL, Ethernet, LAN
networks, TCIP, Tolken ring, Novel, IR, RF, and other wireless
links, or the like.
[0140] The communication station PC software will have the
capabilities listed below: an ability to store and process complete
data sets from several devices in preparation for uploading the
data to an application program or network service; an ability to
display simple text instructions on an LCD display 504; an ability
to enter data such as meter type, phone number, or the like, with
the amount of data entry required to be minimized; an ability to
update code in the field; an ability to store unique device serial
number. In addition, the communication station 500 will have
hardware support for RF communications with the infusion pump 12,
glucose monitors 18, glucose meters 24, or the like, that support
RF communications for program instructions and/or data
transmission. Additional features may be incorporated into future
releases of the software for the communication station following
the product manufacturer date, and thus the communication stations
in the field will have the capability to be updated to newer
releases of software using the in-field code update capability of
the software.
[0141] As shown in FIG. 33, the communication station will include
the following hardware components: a DragonBall 68EZ328 CPU 506
running at 16 MHz; 2 MByte flash memory 508 that is writeable at
least 50,000 times and SMByte DRAM 510 or 4 MB of RAM; an interface
512 to a Seiko G241D01R000 graphics LCD 504; four momentary
switches for interface to an elastomeric keypad 514; a Real Time
Clock 516, that is battery backed-up for 5 years; two RJ11 phone
line connectors 518 and 520 with a passthrough relay; a modem 502;
one female and one male DB9 RS232 ports 16 and 26, with the
capability of multiplexing RX and TX to provide passthrough between
the ports; a serial connection with signal multiplexing that allows
redirection of the serial port to either the IR Circuit or the RF
Circuit; an unregulated 9VDC, 1 Amp power input 32, with out the
need of a power switch; a piezo beeper 522 capable of generating
multiple tones.
[0142] As discussed, the communication station 500 includes a
processor board that has two RJ11 phone line connectors 518 and
520. A passthrough relay 524 will allow the second RJ11 connector
520 to be disconnected from the first during modem communications.
A status bit will be provided to indicate whether the line is in
use. The processor board of the communication station 500 will also
be compatible with the Conexant socket modem technology and will be
useable with 14.4 Kbps, 33.6 Kbps, and 33.6 Kbps world class
modems. In alternative embodiments, the RJ11 connectors 518 and 520
may be formed separate from the processor board, or replaced by a
different connector format. In further alternative embodiments, the
communication station may use higher or lower modem speeds and
modems compatible with other communication standards, such as DSL,
TCIP, ISDN, or the like. The processor board of the communication
station will provide two RS232 ports 16 and 26 with one male and
one female DB9 connectors. Signal multiplexing will provide a
passthrough which connects the two serial ports to each other. The
RS-232 Transceiver shall be .+-.15 kV ESD-Protected. EMI filtering
of the RX and TX signals shall be provided. Only RX, TX, and GND
signals need to be provided to the processor, however all standard
RS232 signals shall be routed when the two ports 16 and 26 are
connected in passthrough mode. In alternative embodiments,
different connector specifications or formats may be used.
[0143] The processor board will have IR circuitry 526 for
communication with the infusion pumps 12, and glucose monitors 18
having IR data transfer circuitry compatible with the circuitry of
the communication station. The processor board will also have RF
circuitry 528 for communication with the infusion pumps, glucose
monitors and future devices that have RF data transfer or
programming capabilities. The communication station 500 is also
designed to communicate with several glucose meters such as the
Medisense Precision QID, and will support for example the following
Precision QID commands: Read Sensor and Erase Sensor. The One Touch
glucose meter will be supported for the following commands:
DM?--Send the Meter's software version and date; DM@--Send the
Meter's serial number; DMF--Send date and time from the Meter's
clock; DMI--dump the data log from the Meter's memory; and
DMP--dump blood, control, and check strip records from the Meter's
memory. In alternative embodiments, other meters and other commands
may be supported.
[0144] The processor board shall be have a beeper 522 which can
generate tones when driven by the Pulse Width Modulation capability
of the Dragonball EZ processor 506. In alternative embodiments,
other audio producing mechanisms, such as a speaker, sound card, or
the like, may be used. The processor board is responsible for
regulating the 9VDC, 1 Amp unregulated power that is provided. The
power connector 32 will be a Kycon Part number KLD-0202-B. The
input circuitry will provide Transient Surge protection, EMI
filtering, and a Resettable Fuse.
[0145] The communication station 500 includes a improved user
interface 512 to make the communication station 500 more versatile.
The communication station 500 uses a Seiko Instruments G241D01R000
graphics LCD 504 that has 240.times.160 pixels. Assuming a minimal
8.times.6 pixel font, this display is capable of displaying up to
30.times.26 characters if oriented vertically or 20.times.40
characters if oriented horizontally. Preferably, the LCD 504 has a
LED backlight. In alternative embodiments, other display devices,
such as CRT, plasma, or the like may be used, different LCD types
and sizes may be used, and the LCD may omit a backlight.
[0146] The user interacts with the communication station 500
through the use of two soft keys 552 and 554 and two arrow keys 556
and 558 used with the display on the LCD 504. Feedback is received
via the LCD and beeper. The user interface allows the user to
navigate a variety of screens including: Menu Screens; Numeric
Entry Screens; Softkey Screens; and Check Screens. An example of a
typical LCD window is shown in FIG. 34.
[0147] FIG. 35 illustrates the main screen, which allows the user
to move an inverted bar over each selection in a list using the
arrow keys 556 and 558. When the desired item is highlighted the
user presses the softkey 554 corresponding to the select option and
that item is selected. After selection, the selected option or
software function is executed.
[0148] FIG. 36 illustrates the alpha-numeric entry window, which
allows the user to scroll through a list of alphanumeric options
using the arrow keys 556 and 558. Once the desired entry is found
the user accepts that entry by pressing the softkey 554
corresponding to the Next operation. The other softkey 552 can be
used to either allow the user to back up a character or cancel
entirely out of the screen. Once the user enters the last number,
the screen is complete.
[0149] FIG. 37 illustrates the softkey screen, which allows the
user to decide on simple options where the user only has two
choices that can be presented on a softkey screen. A softkey screen
simply presents each option as an individual softkey or as a Yes
552 or No 554.
[0150] FIG. 38 illustrates the check screen which, like the menu
screen, uses the arrow keys 556 and 558 to move an inverted bar up
and down over a list of options. Unlike the menu screen, selecting
the option simply places a check mark by the highlighted item. When
the user is done with the screen they may press the softkey 554
labeled done.
[0151] Software in the communication station 500 will support the
user scenarios listed below.
[0152] Scenario 1: Initial Setup
[0153] This scenario describes the first user interaction with the
communication station 500. For instance, the communication station
500 is powered on by plugging in the device. An initial greeting is
presented to the user such as "Welcome to the MiniMed Com Station.
I'm going to ask you a few questions to set things up." A softkey
label continue is presented. The user presses continue and is
presented with the screen "Do you need to do anything special to
get an outside line, such as dial 9?" The user is presented with
softkeys labeled yes and no. If the user hits yes, they are
presented with a numeric entry screen which allows them to enter
the number required for and outside line. The next question the
user is presented with is "Do you have call waiting?". The user is
presented with softkeys labeled yes and no. If the user hits yes,
they are presented with a numeric entry screen which allows them to
enter the number required to disable call waiting. The user is
presented with a screen saying "Congratulations! Setup is complete.
If you ever want to change your setup you can do so from the main
menu" A softkey label continue is presented. The user is then
presented with the main screen. The main screen is a menu screen
with three options: Setup, Collection information, Send information
to a remote source (see FIG. 35).
[0154] Scenario 2: Typical Data Collection and Upload
[0155] This scenario describes the typical user interaction with
the communication station 500. For instance, the user places his
infusion pump 12 or glucose monitor 18 in the cradle 20 or connects
a glucose meter 24 to the serial port 26. The user selects collect
information from the LCD screen 504. The user is presented with a
list of devices. The user selects the infusion pump 12, glucose
monitor 18, and/or glucose meter 24 that is to be download from.
The user receives a message such as "Communicating with <name of
device>. Please wait . . . " Once communication is complete a
message such as "Communication complete. Do you want to send the
collected information to a remote location?" If the user chooses to
send the data to the remote location, they are presented with a
screen that says "Contacting Remote Network Services, please wait."
During the data transfer, the LCD 504 will display a screen that
says "Data being sent to Remote Network Services, please wait . . .
" A progress bar indicates the time remaining. Once the data has
been sent, a message such as "Finished sending data to Remote
Network Services." The user presses continue and is returned to the
main menu.
[0156] Scenario 3: Typical PC Use
[0157] This scenario describes the typical user interaction with
the device. For instance, following the directions on the PC
screen, the user connects a serial cable from their PC 14 to the
communication station 500. When the user clicks a button on the PC
screen, the communication station 500 screen displays the message
"The communication station is in PC controlled mode." The user
follows the instructions on the PC screen. Once the session is
terminated, the communication station 500 returns to the main
menu.
[0158] As discussed above, the communication station 500 can
communicate with a network-based data management service that will
gather device and patient data in a central location and produce
reports for use by care providers, managed care organizations, and
patients, such as disclosed in U.S. Patent Application Ser. No.
60/143,981 filed May 20, 1999 and entitled "Diabetes Integrated
Management System", which is incorporated by reference herein. The
initial goal of a data management service will be to gather device
data with minimal user interaction and fax a report to the care
provider's office in advance of a patient appointment. This service
will rely on communications devices and software in either the
patient's homes or the care provider's offices to gather device
data and transmit it to the data management service via modem. A
communication station 500 will be used as a communication device to
gather data from current medical devices and to interact with the
network-based data management service. Future phases of the data
management service will support direct patient interaction with the
service for the purpose of conducting medical and marketing
surveys, presenting medical instructions, conducting tutorials, and
electronic ordering of supplies.
[0159] The following describes a typical interaction between the
communication station 500 and the network service: For instance,
the communication station 500 calls network server and establishes
initial connection. The server responds with a successful login in
message and server time. The communication station 500 records this
time. In preferred embodiments, the network server never calls the
communication station 500; however, in alternative embodiments, the
network server may call the communication station 500 at periodic
intervals or to check on the status of a patient that is overdue to
transmit data. Next, the communication station 500 downloads an
instr.bat file. This file tells the communication station that it
needs to update its code using newcode.bin and update its screens
using newscreens.xml. The communication station 500 looks and sees
if there are any special instructions just for it on the network
server. To do this it looks for an instruction file with it's
serial number (i.e. SN1234_instr.bat). This file might tell it that
it has a couple of messages waiting specifically for it (i.e.
SN1234_msg1.xml and SN1234_msg2.xml). The communication station 500
then sends a SN1234_hist.dat file. This file contains a log of
errors encountered and other communication station 500 status
information. Next, the communication station 500 sends all the
download data files in its memory using the instr.bat file or the
SN1234_instr.bat if such a file exists. After the transfer is
complete, a success message is sent, and either the network server
or the communication station 500 will terminate the connection.
[0160] The data downloaded from the devices shall be stored in the
exact format they are received. Data shall be transferred using
Xmodem-1K. On manufacture the Real Time Clock 516 is set in such a
way that it is effectively a counter counting minutes and seconds
since the date of manufacture. This counter is battery backed and
never reset. It provides an absolute reference against which all
other times are measured. When devices are downloaded, the time of
the device is recorded along with the manufacture counter time.
This will enable the conversion of the data from device time to
manufacture counter time. In this way, no matter what the variety
of device times, all data can be normalized to manufacture counter
time. When the communication station 500 connects with the network,
the network responds with its time. Upon reception of the network
time, the network time is recorded along with the corresponding
manufacture counter time. This will enable the conversion of the
manufacture counter normalized timestamps to network time.
[0161] The communication station 500 will have the ability to
communicate with a PC 14 via an RS232 link to a DB9 com port 16.
There is a PC Controlled Mode, where upon reception of a command to
put the communication station 500 in PC Controlled Mode, the
communication station 500 locks out all normal functions and places
the message "The communication station is under the control of your
PC, press Cancel to end control". The communication station remains
in PC Controlled Mode until released by the PC 14, the cancel
softkey is pressed on the communication station 500, or the
communication station 500 times out. In PC Controlled Mode the
following commands are available: program the communication station
500; program the PIC Microcontroller in the RF section of the
communication station 500; put a message on the LCD display 504 of
the communication station 500; put the communication station 500
serial ports 26 and 520 in pass through mode; directly communicate
serially with the IR transmitters and receivers 22; directly
communicate serially with the RF transceiver 526; determine what
files are stored in the communication station memory 508 and 510
and download them; instruct the communication station 500 to
download data from specific devices (such as an infusion pump 12)
to the file system. This differs from direct IR or RF
communications in that the PC 14 relies on the communication
station to handle the protocol for communicating with these
devices; and download the communication station 500 history and
status information. There is also a communication station 500 Debug
Mode, which is similar to PC Controlled mode in that it involves
serial communication with a PC. However, unlike PC controlled mode,
the Debug Mode does not lock out normal communication station 500
functioning. In Debug Mode the following commands are available;
program the communication station 500; program the PIC
Microcontroller in the RF section of the communication station 500;
determine what files are stored in the communication station memory
508 and 510 and download them; download the communication station
500 history and status information; simulate a keypress; adjust the
LCD contrast 504; batch program the communication station 500 and
the PIC microcontroller (this allows multiple devices to be
programmed simultaneously); and failure simulation.
[0162] As discussed above, the communication station 500 will have
the ability to perform several levels of in field code update,
including: PIC Microcontroller update; screens update; normal code
update; and Boot Block update. The PIC Microcontroller update is
responsible for updating certain aspects of the RF protocol used in
communicating with the RF data transmitting and programmable
devices. The Screens update changes the screen wording to access
new functions and features. The Normal Code Update updates
everything except for a small amount of boot code. If a normal code
update fails, the boot block provides the code for recovery and
retry. The Boot Block Update remotely updates the boot block.
However, if the update of this portion of code fails, the device
will have to be returned for reprogramming.
[0163] While the description above refers to particular embodiments
of the present invention, it will be understood that many
modifications may be made without departing from the spirit
thereof. The accompanying claims are intended to cover such
modifications as would fall within the true scope and spirit of the
present invention.
[0164] The presently disclosed embodiments are therefore to be
considered in all respects as illustrative and not restrictive, the
scope of the invention being indicated by the appended claims,
rather than the foregoing description, and all changes which come
within the meaning and range of equivalency of the claims are
therefore intended to be embraced therein.
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