U.S. patent application number 12/426090 was filed with the patent office on 2009-09-17 for controlled substance delivery network systems and methods thereof.
Invention is credited to Andrew D. Jacobson, Rasmus T. Kolln, Kenneth R. Rose, Jeff Sommers.
Application Number | 20090234285 12/426090 |
Document ID | / |
Family ID | 40096542 |
Filed Date | 2009-09-17 |
United States Patent
Application |
20090234285 |
Kind Code |
A1 |
Jacobson; Andrew D. ; et
al. |
September 17, 2009 |
CONTROLLED SUBSTANCE DELIVERY NETWORK SYSTEMS AND METHODS
THEREOF
Abstract
In various embodiments, multiple pumps may be used to deliver
substances to multiple respective animals. A computer system may
send/receive information to/from the pumps (e.g., to control and
monitor various aspects of the pumps and/or store information
associated with the pump). In some embodiments, the computer system
may determine respective controlled delivery rates for the pumps
(e.g., based in part on a weight of an animal receiving the
substance from the respective pump) and send the determined
controlled delivery rates to the respective pumps. The computer
system may also receive user identifications from operators
controlling a pump (e.g., in response to a pump alarm) and
documentation indicators entered by the operator and/or pump to use
in documenting pump activity.
Inventors: |
Jacobson; Andrew D.; (San
Antonio, TX) ; Sommers; Jeff; (San Antonio, TX)
; Kolln; Rasmus T.; (Kiel, DE) ; Rose; Kenneth
R.; (San Antonio, TX) |
Correspondence
Address: |
MEYERTONS, HOOD, KIVLIN, KOWERT & GOETZEL, P.C.
P.O. BOX 398
AUSTIN
TX
78767-0398
US
|
Family ID: |
40096542 |
Appl. No.: |
12/426090 |
Filed: |
April 17, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12107470 |
Apr 22, 2008 |
|
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12426090 |
|
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60925881 |
Apr 23, 2007 |
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Current U.S.
Class: |
604/111 ;
604/65 |
Current CPC
Class: |
A61M 2205/3584 20130101;
A61M 2250/00 20130101; A61M 5/142 20130101; A61M 2205/3553
20130101 |
Class at
Publication: |
604/111 ;
604/65 |
International
Class: |
A61M 5/50 20060101
A61M005/50; A61M 5/142 20060101 A61M005/142 |
Claims
1-428. (canceled)
429. A system, comprising: a plurality of pumps operable to deliver
a substance to a plurality of animals via a syringe coupled to the
pump at one or more controlled delivery rates; a computer system
communicatively coupled to at least two of the plurality of pumps,
wherein the computer system is operable to send and receive, to and
from one or more of the plurality of pumps, information identifying
one or more syringes to be used to deliver the substance, wherein
the information comprises a size of the one or more syringes;
wherein the one or more pumps coupled to the computer system are
configured to: detect a size of a syringe coupled to the one or
more pumps and determine if the size of the syringe coupled to the
one or more pumps is the same as a size indicated in the
information sent to the one or more pumps.
430. The system of claim 429, wherein the computer system is
further operable to determine the one or more controlled delivery
rates of substance delivery based on a weight of the animal.
431. The system of claim 429, wherein the computer system is
communicatively coupled to at least one of the one or more pumps
through a wireless network.
432. The system of claim 429, further comprising a box coupled to
at least one of the one or more pumps, wherein the box is operable
to store information received from the computer system for the
pump.
433. The system of claim 429, wherein at least one of the one or
more pumps is operable to receive syringes of different
diameters.
434. The system of claim 429, wherein the information identifying
one or more syringes comprises a diameter of the syringe.
435. The system of claim 429, wherein the information identifying
one or more syringes comprises a length of the syringe.
436. The system of claim 429, wherein the one or more pumps
comprise a mechanism comprising a lever coupled to a gear, wherein
the pump is capable of determining a size of a syringe coupled to
the pump based on a displacement of a component of the
mechanism.
437. The system of claim 429, wherein the one or more pumps are
further operable to provide an indication if the detected size of
the syringe coupled to the pump does not correspond to the size
indicated in the information sent to the pump.
438. The system of claim 437, wherein the indication is an audible
alarm.
439. The system of claim 437, wherein the indication is a graphic
display.
440. The system of claim 429, wherein the one or more pumps are
further operable to inhibit operation of the pump while the
detected syringe size does not correspond to the size indicated in
the information sent to the pump.
441. A method, comprising: sending information identifying one or
more syringes to be used to deliver a substance to a respective
animal to one or more pumps, wherein the information comprises a
size of the one or more syringes, and wherein the one or more pumps
are operable to deliver the substance to the respective animal via
a syringe coupled to the pump at one or more controlled delivery
rates; and coupling a syringe to one or more of the pumps receiving
the information, wherein the one or more pumps automatically detect
a size of the syringe coupled to the one or more pumps; determining
if the detected size of the syringe coupled to the one or more
pumps is the same as a size indicated in the information sent to
the one or more pumps.
442. The method of claim 441, wherein the information identifying
one or more syringes comprises a diameter of the syringe.
443. The method of claim 441, wherein the information identifying
one or more syringes comprises a length of the syringe.
444. The method of claim 441, further comprising the pump providing
an indication if the detected size of the syringe coupled to the
pump does not correspond to the size indicated in the information
sent to the pump.
445. The method of claim 444, wherein the indication is an audible
alarm.
446. The method of claim 444, wherein the indication is a graphic
display.
447. The method of claim 441, inhibiting operation of a pump while
the detected syringe size does not correspond to the size indicated
in the information sent to the pump.
448. The method of claim 441, further comprising storing the sent
information in a box coupled to the pump.
449. The method of claim 448, further comprising: decoupling the
box from the pump; and coupling the box to a different pump;
wherein the box is operable to communicate the stored information
to the different pump when coupled to the different pump.
Description
PRIORITY CLAIM
[0001] This is a continuation application of, and claims the
benefit of priority under 35 USC .sctn.120, to co-pending U.S.
patent application Ser. No. 12/107,470 titled "Systems and Methods
for Controlled Substance Delivery Network", filed Apr. 22, 2008,
which claims the benefit of priority under USC .sctn.119(e), to
U.S. Provisional Patent Application Ser. No. 60/925,881 titled
"Information network including medical infusion pumps and other
medical devices", filed on Apr. 23, 2007, the disclosures of which
are hereby incorporated by reference in their entirety as though
fully and completely set forth herein.
BACKGROUND
[0002] The pharmaceutical industry, contract research
organizations, academia, and government entities routinely test the
efficacy and safety of new chemical entities using intravenous
(usually) infusion in lab animals including, for example, rats,
dogs and nonhuman primates. While some acute infusion studies may
be performed in a small number of lab animals (e.g., .ltoreq.10)
over several minutes or hours, large-scale "toxicology" infusion
studies of, for example, several hundred rats or, for example, 10's
of larger animals such as dogs or nonhuman primates for periods
lasting, for example, from 30-90 days may also be performed.
[0003] Medical infusion pumps (e.g., electromechanical medical
infusion pumps) may be used during these studies (as well as in
other veterinary and/or human medical applications). There are
numerous types of electromechanical medical infusion pumps
including syringe, peristaltic, diaphragm, large volume, stationary
("pole mount"), and portable ("ambulatory"). These pumps may be
used to deliver a substance (such as a drug) at a controlled
delivery rate to, for example, a laboratory test animal. Lab animal
infusion and human-use infusion may share similar pump technology.
The methods of use in each field may differ in that human-use
infusion (e.g., in a healthcare application) may be tailored to a
single patient's needs while lab animal infusion (e.g., in an
industrial application) may apply common parameters to multiple
animals.
[0004] Animals may be connected to a medical infusion pump (for
example, a syringe pump, though other pumping mechanisms may also
be used) through a catheter, tubing, tether, fluid swivel, etc.
Usually, one pump is used per animal and operators may program and
monitor each pump manually. Operators may manually enter a delivery
rate into a pump, load a substance-filled syringe for the pump, and
then activate the pump (e.g., by pressing a start button).
Operators may also interact with numerous medical and monitoring
devices involved in the study. The process of loading, starting,
and stopping the pump, recording data from medical and monitoring
devices, and, for example, responding to pump alarms may be
manually documented by the operator (e.g., on a clipboard). Because
studies often involve large numbers of animals, manually setting up
numerous pumps may be time consuming and tedious. In addition, Good
Laboratory Practices (GLP's) (including documentation of processes,
data collection, and study results) are required by regulatory
agencies such as the Food and Drug Administration (FDA). Manually
documenting the processes, data collection, and study results may
also be time consuming, tedious and subject to human error.
SUMMARY
[0005] In various embodiments, a pump may receive a controlled
delivery rate (e.g., from a computer system) to be used to deliver
a substance to an animal (e.g., to study the effects of the
substance on the respective animal). In some embodiments, multiple
pumps may communicate with the computer system and may be used to
deliver substances at respective received controlled delivery rates
to respective animals (e.g., one animal per pump). In some
embodiments, the computer system may also send/receive other
information to/from the pumps (e.g., to control various aspects of
the pumps and/or store information associated with the pumps). In
some embodiments, the computer system may determine respective
controlled delivery rates for the pumps based in part on a weight
of a respective animal receiving the substance from the respective
pump and/or for example, a study group the animal is in. For
example, a study may involve testing one group of animals with a
high dose of a substance, one group with a mid dose of the
substance, one group with a low dose of the substance, and one
group with a control substance (other study configurations are also
contemplated). In some embodiments, the computer system may
calculate and then send the determined controlled delivery rates to
the respective pumps in response to a global command (e.g.,
received from an operator). The pumps may use the received
determined controlled delivery rates to control the rate of
substance delivery to a respective animal that is receiving the
substance from the respective pump (e.g., through an intravenous
(IV) connection to a syringe with the substance being controlled by
the pump). In some embodiments, the computer system may display
respective graphical profiles of the controlled delivery rates over
time for the respective pumps. The graphical profiles may also
include indicators marking the graphical profile at the current
time point in the study.
[0006] In some embodiments, pumps and other equipment (e.g.,
medical or monitoring devices) may communicate with the computer
system through wired and/or wireless connections. For example, the
connections may form a mesh network allowing the computer system to
send and receive information to the pumps and other equipment. In
some embodiments, the computer system may communicate with the
pumps and other equipment through a data hub. In some embodiments,
the pumps and other equipment may be coupled to a box operable to
send/receive communications to/from the network. The boxes may also
include memory for storing information such as instructions (e.g.,
for the pump), a controlled delivery rate, a start time, a stop
time, a duration, a target volume, etc. to allow the box to provide
the instructions, etc. in the event of a computer system failure
and/or to allow the box to be placed on a different pump if the
original pump should fail (or for some other reason need to be
disconnected from the study).
[0007] In some embodiments, the computer system may receive
information such as weights (e.g., from a weight scale, file, or
remote computer), sensor data (e.g., from monitoring sensors either
implanted in the animals or coupled to cages holding the animals),
documentation (e.g., including user identifiers and documentation
identifiers for respective events occurring in the network such as
pump starting, pump stopping, alarm, alarm cleared, how alarm was
cleared, etc). User identifiers (e.g., personal identification
numbers (PINs)) may be used to authenticate an operator prior to
allowing the operator to perform an action on the pump (or other
equipment). The user identifier may also be stored with a received
documentation identifier to indicate which operator performed the
respective action. In some embodiments, user identifiers and
documentation indicators (e.g., when clearing an alarm) may be
required prior to continued system access and/or prior to
restarting pump operation (e.g., if stopped after an alarm).
[0008] In some embodiments, the computer system may communicate
with the pumps and/or weight scales associated with the pumps for
in process pump validation. For example, an operator may weigh a
syringe before a pump pumps a substance and after the pump pumps
the substance according to a received controlled delivery rate. The
weights (and, for example, start and stop times) may be used to
validate the pump (e.g., determine if the expected delivery rate is
within an acceptable range of the actual delivery rate (output
volumes may also be used in the validation)). The computer system
may also track calibration dates for the pumps and may warn an
operator (or, for example, inhibit pump operation) of pumps that
have gone past their calibration intervals (or will go past their
calibration intervals during the study).
[0009] In some embodiments, the computer system may communicate
with a filling pump (either coupled or not coupled to an animal) to
fill syringes with an amount of substance needed for a next phase
of a study. For example, after determining a controlled delivery
rate for a pump (and a duration of pumping at the determined
controlled delivery rate), the computer system may determine and
communicate an amount of substance needed in a respective syringe
(or, for example, a syringe plunger displacement indication, etc.)
to a filling pump and the filling pump may fill the respective
syringe with the indicated amount of substance (the syringe and a
vat of the substance to be used to fill the syringe may be coupled
to the filling pump by an operator). An indicator (e.g., printed
directly on the syringe or on a label to be coupled to the syringe)
may be placed on the syringe to assist the operator in placing the
syringe on the respective pump (in some embodiments, the same pump
may fill the syringe and deliver the substance to the respective
animal). In some embodiments, the computer system may calculate
several syringe amounts and may display (or, for example, print)
the list for an operator to use in preparing syringes for future
phases of the study (e.g., the list may include entries with a pump
indicator, a time indicator, an amount indicator, an animal
indicator, etc. along with the substance amount to fill the
respective syringe with). In some embodiments, when a syringe is
placed into a pump, the pump (e.g., using information stored in the
box and/or received from the computer system) may check a diameter
of the received syringe to make sure the received syringe diameter
corresponds to the expected syringe diameter (different sized
syringes may be used at different times in the study). In some
embodiments, the pump may indicate an error and/or not pump the
syringe if the diameters do not match.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] A better understanding of the present invention may be
obtained when the following detailed description is considered in
conjunction with the following drawings, in which:
[0011] FIG. 1 illustrates a pump and an animal cage, according to
an embodiment.
[0012] FIG. 2a illustrates multiple pumps communicating with a
computer system, according to an embodiment.
[0013] FIG. 2b illustrates multiple pumps communicating with a
computer system through respective boxes, according to an
embodiment.
[0014] FIG. 3 illustrates a box, according to an embodiment.
[0015] FIG. 4 illustrates a food consumption monitoring device,
according to an embodiment.
[0016] FIG. 5 illustrates an embodiment of monitoring devices for
monitoring the micro-environments of multiple animal cages in a
rack and cage system.
[0017] FIG. 6 illustrates a data hub communication arrangement
including a pump and medical and monitoring devices wired to an
external stand-alone data hub, according to an embodiment.
[0018] FIG. 7 illustrates a rack hub communication arrangement with
multiple pumps and medical and monitoring devices in a rack wired
to an external stand-alone data hub, according to an
embodiment.
[0019] FIG. 8 illustrates a box communication arrangement with a
pump and medical and monitoring devices respectively coupled to a
removable piece of wireless communications hardware, according to
an embodiment.
[0020] FIG. 9 illustrates a set-up screen for a study, according to
an embodiment.
[0021] FIG. 10 illustrates a security set-up screen, according to
an embodiment.
[0022] FIG. 11 illustrates a communications port set-up screen,
according to an embodiment.
[0023] FIG. 12 illustrates a user set-up screen, according to an
embodiment.
[0024] FIG. 13a illustrates a graphical user interface for
pump/animal assignment, according to an embodiment.
[0025] FIG. 13b illustrates graphical user interface for equipment
access, according to an embodiment.
[0026] FIG. 14 illustrates a pump set-up screen, according to an
embodiment.
[0027] FIG. 15a illustrates a graphical profile for a substance
delivery, according to an embodiment.
[0028] FIG. 15b illustrates a listing of future syringes, according
to an embodiment.
[0029] FIG. 16 illustrates an electronic log, according to an
embodiment.
[0030] FIG. 17 illustrates a flowchart of a method for controlled
delivery rate determination and global command rate distribution,
according to an embodiment.
[0031] FIG. 18 illustrates a flowchart of a method for pump
validation, according to an embodiment.
[0032] FIG. 19 illustrates a flowchart of a method for automated
syringe filling, according to an embodiment.
[0033] FIG. 20 illustrates a flowchart of an embodiment for study
documentation.
[0034] FIG. 21 illustrates an embodiment of a wide area network
(WAN) and a local area network (LAN).
[0035] FIG. 22 illustrates an embodiment of computer system that
may be suitable for implementing various embodiments of a system
and method for substance delivery and monitoring.
[0036] While the invention is susceptible to various modifications
and alternative forms, specific embodiments thereof are shown by
way of example in the drawings and will herein be described in
detail. It should be understood, however, that the drawings and
detailed description thereto are not intended to limit the
invention to the particular form disclosed, but on the contrary,
the intention is to cover all modifications, equivalents, and
alternatives falling within the spirit and scope of the present
invention as defined by the appended claims. Note, the headings are
for organizational purposes only and are not meant to be used to
limit or interpret the description or claims. Furthermore, note
that the word "may" is used throughout this application in a
permissive sense (i.e., having the potential to, being able to),
not a mandatory sense (i.e., must). The term "include", and
derivations thereof, mean "including, but not limited to". The term
"coupled" means "directly or indirectly connected".
DETAILED DESCRIPTION OF THE EMBODIMENTS
[0037] FIG. 1 illustrates an embodiment of pump 101a (e.g., a
medical infusion pump) and a laboratory animal cage 117 for animal
103a. In various embodiments, pump 101 ("pump 101" used generally
herein to refer to pumps 101a, 101b, 101c, etc.) may be used to
deliver substance 119 to animal 103 ("animal 103" used generally
herein to refer to animals 103a, 103b, 103c, etc.) at a controlled
delivery rate (e.g., to study the effects of substance 119 on
respective animal 103). In some embodiments, the controlled
delivery rate may be calculated, for example, by computer system
201 (e.g., see FIG. 2) and communicated to pump 101 for use in
delivering substance 119 to animal 103. As discussed herein, other
information may also be communicated between computer system 201,
pumps 101, and other equipment in an animal drug study. While
embodiments described herein include animal applications (e.g.,
laboratory/veterinary research applications), other applications
are also contemplated (e.g., human study applications).
[0038] In some embodiments, pump 101 may include a stepper motor to
push a plunger on syringe 109 to deliver substance 119 in syringe
109 at the controlled delivery rate (or pull the plunger to load
substance 119 into syringe 109). While syringe 109 is used
throughout, other delivery containers (e.g., a holding tank) are
also contemplated. Other pump types are also contemplated (e.g.,
peristaltic, diaphragm, large volume, stationary ("pole mount"),
and portable ("ambulatory")). Animals 103 may include rodents,
pigs, rabbits, dogs, cats, nonhuman primates, etc. Substances 119
may include a saline solution, a drug solution, or a control
solution (which may be a saline solution). Other substances 119 are
also contemplated. In some embodiments, substance 119 may be a
liquid delivered through tube 105 on animal 103 which may deliver
substance 119 intravenously (through a catheter 107) to animal 103.
Other routes of administration are also contemplated. For example,
substance 119 may be an airborne particle that is pumped into an
animal's breathing space or a solid/liquid substance that is pumped
into the animal's digestive system. Substance 119 may also be
applied to the animal's eyes, ears, skin, etc. (e.g., by a spray
pump). In some embodiments, counter balance 111, swivel 113, and
spring tether 115 may be used to guide and stabilize tube 105
transporting substance 119 to animal 103 in animal cage 117. Other
configurations are also contemplated.
[0039] FIG. 2a illustrates multiple pumps 101 communicating with
computer system 201, according to an embodiment. In some
embodiments, multiple pumps 101 (e.g., pumps 101b, 101c, 101d, and
101e) may be used to deliver substances 119 to multiple respective
animals 103 (e.g., animals 103b, 103c, 103d, and 103e). For
example, a toxicity study may include delivering different
respective amounts of a drug to different animals (e.g., one animal
103 per pump 101) to determine the toxic effects (if any) of the
drug and to determine ideal drug amount/body weight ratios. Other
study types and study characteristics (e.g., effects of the drug on
different genders, age groups, etc.) are also contemplated. Studies
may require testing tens, hundreds, or thousands of animals over a
few hours, days, weeks, etc. Animal studies may be preliminary to
human studies (e.g., for obtaining FDA approval). For example,
animal studies may be used in researching new formulations for
drugs to treat diseases (e.g., heart disease, diabetes, etc.)
[0040] In some embodiments, pumps 101 may communicate with computer
system 201 through network 203 (e.g., through wired and/or wireless
communications). Computer system 201 may be a personal computer
(such as a desktop or laptop), mainframe, etc. Other computer
system types are also contemplated. In some embodiments, computer
system 201 may include several computer systems communicatively
coupled together. In some embodiments, computer system 201 may
send/receive information to/from pumps 101 and other equipment
involved in the study (e.g., medical or monitoring devices such as
weight scale 217). For example, computer system 201 may receive
weight data from weight scales 217 to determine, for a respective
pump 101, a respective controlled delivery rate for delivering
substance 119 to animal 103. Computer system 101 may then send the
determined controlled delivery rate to the respective pump 101.
Each animal 103 may have an individual weight scale 217 (e.g.,
incorporated in respective animal cage 117) or multiple animal
cages 117 may share a weight scale 217. In some embodiments, weight
scale 217 may communicate (e.g., measured animal weights) with
computer system 201 through network 203.
[0041] In some embodiments, computer system 201 may provide an
interface for operator 401 (e.g., see FIG. 4) to automate control
of pumps 101 and the other equipment involved in the study.
Information may also be received at computer system 201 from pumps
101 and other equipment (e.g., other medical or monitoring devices)
communicatively coupled to computer system 201. For example,
information may be entered at pump 101 through an operator
interface 123 (e.g., an alpha/numerical keypad, a full Qwerty
keyboard, etc). In some embodiments, information may also be
displayed on pump display 121 (e.g., see menu displayed on display
121 in FIG. 1). Other pump configurations are also contemplated.
Computer system 201, pumps 101, and/or other medical or monitoring
devices may also be operable to communicate (e.g., send and receive
data and instructions) with personal digital assistants (PDAs),
cell phones, smart cards, etc. For example, operator 401 may send
information to computer system 201 through a PDA (e.g., an animal
weight, documentation of a study event, etc). As another example,
operator 401 may send information to pump 101 by entering the
information into a PDA; the PDA sending the information to computer
system 201, and the information being transmitted to pump 101 from
computer system 201 over network 203. As another example, operator
401 may send information to computer system 201 by entering the
information into a PDA; the PDA sending the information to pump
101, and the information being transmitted to computer system 201
from pump 101 over network 203. Computer system 201 may be used by
operator 401 to set-up a study (e.g., by calculating respective
controlled delivery rates) and automate documentation for the study
(e.g., associated with pumps 101 and the other equipment involved
in the study). Automating control may save substantial time over
manual pump set-ups. In addition, automating documentation may
result in more accurate and complete study documentation (often
required by the FDA and other regulatory bodies) and may force
operators 401, etc. to enter documentation at the appropriate times
(e.g., during a pump alarm).
[0042] In some embodiments, computer system 201 may determine
respective controlled delivery rates for substance delivery for
pumps 101 (e.g., based in part on a weight of animal 103 receiving
substance 119 from respective pump 101) and send the determined
controlled delivery rates to respective pumps 101. In some
embodiments, controlled delivery rates may include
[dose/time]/animal weight ([ml/hr]/kg) where dose may indicate a
substance concentration. Other controlled delivery rates are also
contemplated (e.g., non-weight based controlled delivery rates may
include dose/time (ml/hr)). Pumps 101 may use the received
determined controlled delivery rate to control the rate of
substance delivery to animal 103 that is receiving substance 119
from respective pump 101.
[0043] In some embodiments, studies may involve testing groups of
animals with different levels of drug doses. For example, a study
may involve testing one group of animals with a high dose of
substance 119, one group with a mid dose of substance 119, one
group with a low dose of substance 119, and one group with a
control (other study configurations are also contemplated). In some
embodiments, computer system 201 may also use the study group
criteria in determining the respective controlled delivery rate for
pump 101 (e.g., in addition to the determined animal weight). Pumps
101 in the high dose group may be provided a controlled delivery
rate with an increased dose of the drug per unit of body weight
than the mid or low dose group pumps 101. In some embodiments,
study ratios (of substance amount per unit body weight) may be
provided to computer system 201 (e.g., by operator 401) for each
group along with a number of animals 103 to test in each dose group
(or a respective percentage of the total number of animals to
include in each group). For example, operator 401 may provide a
spreadsheet with the ratios (and, for example, other test
parameters such as animal type, gender, age, etc.) to computer
system 201. Other information may also be received (e.g., time
periods for administering the drugs). Other sources of the study
information are also contemplated (e.g., downloaded from a remote
computer). Computer system 201 may use this information to set up
which pumps 101 will provide which dose levels. The respective
weights of the animals may also be received by computer system 201
(e.g., on a spreadsheet, through manual entry on a pump interface
123, through a weight received from weight scale 217 associated
with pump 101, etc). Computer system 201 may arrange pump groupings
(e.g., by assigning pumps 101 to respective groups), pump
controlled delivery rates, etc. and communicate the resulting
respective controlled delivery rates to respective pumps 101
throughout the study.
[0044] In some embodiments, pumps 101 and/or other medical or
monitoring devices may communicate over network 203 with computer
system 201 through wired and/or wireless communications. For
example, pumps 101 (e.g., pumps 101f, 101g, 101h, and 101i) and/or
other medical or monitoring devices may include and/or be coupled
to wireless communication devices such as Wireless Fidelity (IEEE
802.11b wireless networking) (Wi-Fi) transmitter/receiver,
Bluetooth transmitter/receiver), etc. for communication with
computer system 201. In some embodiments, pumps 101 and/or other
medical or monitoring devices (e.g., as seen in FIG. 2b) may
communicate with computer system 201 through boxes 205 (e.g., see
boxes 205a, 205b, 205c, and 205d (referred to generally herein as
boxes 205)). In some embodiments, box 205 attached to a
communication port of pump 101 and/or other medical or monitoring
devices (e.g., through communication port 307 as seen in FIG. 3)
may send/receive information to/from pump 101 (and/or other medical
or monitoring devices) and computer system 201 (e.g., wirelessly
through wireless transmitter/receiver 309 or through a wired
connection through communication port 311). In some embodiments,
box 205 may not be physically attached to pump 101 and/or other
medical or monitoring devices, but may communicate with pump 101
and/or other medical or monitoring devices through wireless
transmitter/receiver 309 (which may include a separate transmitter
and receiver or a transceiver). Other communication configurations
are also contemplated. As seen in FIG. 2b, pumps 101f, 101g, 101h,
and 101i may use respective controlled delivery rates received from
computer system 201 to pump the determined respective amounts of
substance 119 into animals 103f, 103g, 103h, and 103i.
[0045] In some embodiments, pumps 101 and/or other medical or
monitoring devices may also be coupled to computer system 201
through wired connections (in some embodiments, boxes 205 may
provide wired and/or wireless connections). In some embodiments,
pumps 101 and/or other medical or monitoring devices may have
communication ports (e.g., serial RS-232, Universal Serial Bus
(USB), Ethernet, other communications (COM) port, etc). Connections
may be made through the communication ports directly to computer
system 201 (e.g., through a wired connection) or indirectly to
computer system 201 (e.g., box 205 may be coupled to the
communication port and may send/receive communications to/from
computer system 201 through a wired and/or wireless connection).
Other connections are also contemplated.
[0046] In some embodiments, network 203 may be a mesh network.
Through the mesh network, pumps 101 (and, for example, other
medical or monitoring devices) in network 203 may communicate
directly with each other and/or communicate with each other via
computer system 201. For example, computer system 201, boxes 205,
etc. may use a ZigBee.TM. wireless protocol for peer-to-peer
communication (which may provide alternate communication paths in
the network 203 if a direct path is not available). In some
embodiments, computer system 201, boxes 205, etc. may communicate
with each other through a router. In some embodiments, the router
may be external or internal to computer system 201. Other network
configurations and protocols are also contemplated.
[0047] In some embodiments, pump 101 may access memory 305. Memory
305 may be internal to pump 101 or may be external to pump 101
(e.g., memory 305 may be in box 205 communicatively coupled to pump
101). Memory 305 may include a non-volatile memory (e.g., flash
memory) or volatile memory (e.g., Random Access Memory (RAM)).
Other memory types are also contemplated. In some embodiments,
memory 305 may store information such as instructions (e.g., for
pump 101), a controlled delivery rate, a start time, a stop time, a
duration, a target volume, etc. for pump 101 from computer system
201. For example, memory 305 may store the received controlled
delivery rate, a start time, and a duration from computer system
201 for pump 101 to use in pumping substance 119 to animal 103.
Other combinations are also contemplated (e.g., memory 305 may
store controlled delivery rate and target volume or controlled
delivery rate and a start and stop time). Memory 305 may also
include program instructions (e.g., received from computer system
201) to control pump 101. For example, the programming instructions
may be stored as firmware on memory 305. Because instructions for
pump 101 may be stored on memory 305, if computer system 201 fails
(or, for example, is restarted, disconnected, etc.), pumps 101 may
continue operation per the instructions stored on memory 305. In
some embodiments, programming instructions for determining the
controlled delivery rate for pump 101 may be stored in memory 305.
The controlled delivery rate may be determined based on information
collected at pump 101 and corresponding information may be sent to
computer system 201 for storage (e.g., the animal's weight, the
controlled delivery rate, etc). In some embodiments, computer
system 201 may communicate information needed for the calculation
to pump 101 and/or box 205 (e.g., a dose ratio assigned to
respective pump 101) to be used with the programming instructions
on memory 305 and/or other data in memory 305 for the calculation.
Memory 305 may also include, for example, alarm codes, menu options
for indicating how alarms were solved, etc. Memory 305 may also
store information sent to and received from computer system 201
(e.g., as serve as a back-up for computer system 201). In some
embodiments, memory 305 may be accessible to other medical or
monitoring devices (e.g., internal to the devices or externally
accessible to the devices) for storing information (e.g.,
information sent/received to/from computer system 201) and/or
instructions for these devices. For example, box 205 with memory
305 may be coupled to a medical or monitoring device's
communications port. In addition to memory 305, box 205 may include
processor 303 to access memory 305, electronic clock 313, and
communications circuitry 301. In some embodiments, the memory 305
and wireless transmitter/receiver 309 may be on the same printed
circuit board (PCB). Other configurations are also contemplated. In
some embodiments, memory 305 may be included in a router (e.g.,
external to computer system 201) to allow continued operation of
pumps 101, medical and monitoring devices, network 203, etc. if
computer system 201 fails (or, for example, is restarted,
disconnected, etc).
[0048] In some embodiments, box 205 may be replaced on pump 101
(and/or other medical or monitoring device) (e.g., if box 205
fails, is not functioning properly, is being updated, etc). For
example, an external box 205 may be replaced without replacing or
repairing pump 101 (and/or other medical or monitoring device). If
the memory 305 and/or communications circuitry 301 is on box 205
instead of an interior of pump 101, the memory 305 and
communications circuitry 301 may be easier to repair/replace by
replacing box 205 (as opposed to accessing the interior of pump
101). In some embodiments, if pump 101 (or other medical or
monitoring device) fails, is not functioning properly or, for
example, is being updated, box 205 may be placed on a different
pump 101 (or other medical or monitoring device). In some
embodiments, box 205 may not need to be reprogrammed after the
switch (e.g., box 205 may interact with the new pump to perform the
functionality expected of the previous pump (e.g., controlled
delivery rate, delivery schedule, etc)). In some embodiments, box
205 may be configured to interface with different types of pumps
101 (and/or other medical or monitoring device). Box 205 may
include dedicated programming instructions specific to the pump
style (or style of other medical or monitoring device). In some
embodiments, the pump 101 (and/or other medical or monitoring
device) may include programming instructions to be compatible with
box 205. In some embodiments, box 205 may be internal to pump 101
(and/or medical or monitoring device) and pump 101 (and/or medical
or monitoring device) may be repaired or replaced if the internal
box 205 is not functioning properly (or, for example, to update box
205). In some embodiments, box 205 may include a wireless
communications device with one or more communication port
connectors (e.g., serial RS-232, USB, Ethernet, etc) to configure
box 205 to communicate with a specific pump 101. In some
embodiments, communications circuitry 301 (and, for example,
wireless transmitter/receiver 309, communication ports 307/311)
processor 303, memory 305, and/or electronic clock 313 may be
internal to pump 101 (and/or medical or monitoring device). Other
placements are also contemplated.
[0049] In some embodiments, other medical or monitoring devices
(e.g., used to treat or monitor humans or animals 103) may
communicate with computer system 201. For example, the medical or
monitoring devices (e.g., sensors) may monitor physiologic
parameters (e.g., animal temperature, activity, pulse oxymetry,
heart rate, blood pressure, metabolic function, etc) and animal
cage conditions (e.g., a micro-environment monitoring apparatus may
measure animal cage temperature, humidity, ammonia level, etc)). As
seen in FIG. 4, a monitoring device may include a food and/or water
consumption monitoring device 403 (e.g., for one animal cage 117 of
a collection of animal cages). In some embodiments, network 203 may
include individual laboratory animal cages 117 with respective
devices for monitoring the weight of feed dispensed (and, in some
embodiments, consumed) (e.g., food consumption monitoring device
403) by animal 103 (e.g., a rat) in the respective animal cages 117
(e.g., separate monitoring devices for each of the respective
animal cages 117). FIG. 5 illustrates an embodiment of monitoring
devices for monitoring the micro-environments of multiple animal
cages 117 in a rack and cage system 405. The medical or monitoring
device may include a rack and cage system 405 including multiple
laboratory animal cages 117 and micro-environment monitoring
devices attached to respective animal cages 117 to measure
conditions within each animal cage 117 (e.g., temperature,
humidity, etc). This micro-environment data may be transmitted to
computer system 201 (e.g., wirelessly through communications
circuitry in the monitoring devices or box 205 coupled to the
monitoring devices).
[0050] In some embodiments, medical or monitoring devices may
include weight scale 217 used to determine a weight of animal 103,
cage 117, etc. Other weight determinations are also contemplated
(e.g., the weight of a syringe for pump 101 may be weighed in
weight scale 217 for transmission to computer system 201). In some
embodiments, computer system 201, weight scale 217 (and/or other
medical or monitoring devices), and pump 101 may form a closed
information loop. Other information arrangements are also
contemplated. Other medical or monitoring devices are also
contemplated (e.g., a Wireless Information Device (WID) reader for
animal identification based on an implanted, external, and/or
wearable Radio Frequency Identification (RFID) chips) may be used
to identify specific animals associated with a specific animal cage
117 (e.g., with the reader). Medical or monitoring devices may thus
include monitoring sensors either implanted in animals 103 or
coupled to cages 117 holding animals 103. Medical or monitoring
devices may transmit and receive information to/from computer
system 201 (e.g., through wired and/or wireless communications). In
some embodiments, pumps 101 (and/or medical or monitoring devices)
in network 203 may have unique addresses (e.g., unique Internet
protocol (IP) addresses). Other unique address types are also
contemplated (e.g., Media Access Control (MAC) addresses). In some
embodiments, computer system 201 may use the unique addresses to
send/receive information to/from pumps 101 (and/or medical or
monitoring devices) to control, monitor, and/or store information
associated with pumps 101 (and/or medical or monitoring
devices).
[0051] In some embodiments, computer system 201, pumps 101 (and/or
other medical or monitoring devices) may communicate with other
computers (e.g., via an intranet or Internet 211). For example,
information from computer system 201 may be sent to server 207 in
communication with remote personal computers 209 (e.g., computers
209a, 209b, and 209c) over Internet 211. In some embodiments, a
network of remote computers may communicate with computer system
201 for remote access to data in computer system 201 (e.g., remote
computers 209 may communicate with computer system 201 via Internet
211 and/or via server 207 coupled to and/or including computer
system 201). In some embodiments, other remote computers 215 (e.g.,
computers 215a, 215b, and 215c) may access computer system 201
through server 207. Remote access may allow operators 401 (e.g.,
remote operators) to monitor and/or control equipment in the study,
access documentation, etc. Other uses for remote access are also
contemplated. In some embodiments, computer system 201 may notify
an entity (e.g., operator 401) of the status (e.g., normal or
abnormal) of pumps 101 and/or medical or monitoring devices and may
allow the entity to control pumps 101 and/or medical or monitoring
devices communicating through network 203. In some embodiments,
computer system 201 may notify operator 401 via electronic mail
messages, text messages, paging, voice messaging, etc. of a status
and, for example, may receive control instructions through operator
mobile device 213 (e.g., a phone, PDA, etc).
[0052] In some embodiments, computer system 201 may communicate
through wired, wireless, or a combination of wired and wireless
network hardware to pumps 101 and/or medical or monitoring devices
to program, monitor, and collect data from the pump 101 and/or
medical or monitoring devices. The network combinations may
include, for example, a data hub communication arrangement (e.g.,
see FIG. 6), a rack hub communication arrangement (e.g., see FIG.
7), a box communication arrangement (e.g., see FIG. 8), or various
subsets and/or combinations of these communication arrangements
(other network configurations are also contemplated).
[0053] FIG. 6 illustrates an embodiment of the data hub
communication arrangement including pump 101 and/or medical or
monitoring devices wired (or wirelessly connected) to data hub 601
(e.g., an external stand-alone data hub). FIG. 6 illustrates an
embodiment including rack 405 with multiple cages 117, integrated
direct current (DC) power ports, and a universal, removable power
supply (other configurations are also contemplated). FIG. 7
illustrates an embodiment of a rack hub communication arrangement
with multiple pumps 101 and/or medical or monitoring devices in
rack 405 wired or wirelessly connected to data hub 601 (e.g., an
external stand-alone data hub mounted to rack 405). FIG. 7
illustrates an embodiment of rack 405 with multiple cages 117 and a
mounted data hub 601 operable to handle the infusion groups within
the single rack 405 (other configurations are also contemplated).
In some embodiments, cage rack 405 may also include integrated
washable DC power ports and a Universal, removable power supply.
Other data hub types and placements are also contemplated. The data
hub hardware may include embedded programming instructions operable
to allow data input to/from multiple devices (e.g., pump 101 and/or
medical or monitoring devices (such as sensors and weight scales),
etc.) and to/from computer system 201. Data hub 601 (e.g., a
universal data hub) may be placed on, in or proximate to animal
cage 117, pump 101, and/or medical or monitoring device (e.g., one
data hub 601 per animal cage 117, one data hub 601 per pump 101,
one data hub 601 supporting multiple animal cages 117 in rack 405,
etc). In some embodiments, a single data hub 601 may be located at
each of one or more animal cages 117. In some embodiments, a single
data hub 601 may be coupled to multiple animal cages 117 (e.g.,
coupled to rack 405). Other configurations are also contemplated.
In some embodiments, pump 101 and/or medical or monitoring devices
dedicated to animal cage 117 may communicate bi-directionally with
data hub 601 and to computer system 201 (e.g., through data hub
601).
[0054] In some embodiments, data hub 601 may accommodate multiple
wired and/or wireless data platforms and protocols used in pumps
101, and/or medical or monitoring devices (e.g., Ethernet, RS232,
USB, Wi-Fi, Bluetooth, etc). For example, data hub 601 may pass
through (and/or convert) communications to/from pumps 101 and/or
medical or monitoring devices to/from computer system 201. In some
embodiments, data hub 601 may integrate multiple data sources from
pumps 101 and/or medical or monitoring devices into a data stream
for transmission to computer system 201 (e.g., wirelessly). In some
embodiments, data hub 601 may multiplex various communications from
pump 101 and/or medical or monitoring devices to computer system
201. Computer system 201 may separate the data streams (e.g., using
a pre-arranged template shared with data hub 601 and/or a
demultiplexer). Other communication formats are also contemplated
(e.g., data to/from pump 101 and/or medical or monitoring devices
may be transmitted/received as single serial streams). Computer
system 201 may transmit information intended for pump 101 and/or
medical or monitoring devices to data hub 601 for delivery to the
intended pump 101 and/or medical or monitoring devices (these
streams may also be combined/multiplexed streams or separate
streams). In some embodiments, data hub 601 may support a generic
platform to transmit and receive data to/from several different
types of platforms (e.g., different pump types, different computer
systems, etc). In some embodiments, data hub 601 may include
programming instructions to convert data in one platform to another
platform prior to sending the data to an intended device.
[0055] In some embodiments, data hub 601 may transmit
bi-directional data for a single animal cage 117 to computer system
201 (e.g., via wired or wireless hardware) or data hub 601 may
transmit bi-directional data for animal cages 117 in rack 405 to
computer system 201 (e.g., via wired or wireless hardware). In
various embodiments, a lab animal cage rack 405 (other rack types
are also contemplated) may hold multiple animal cages 117 (e.g.,
10, 100, 1000, etc). The cage rack 405 may include power sources
603 (which may be integrated in the cage rack 405) and wires as
well as data communication devices and wires for pumps 101 and/or
medical or monitoring devices on animal cages 117. In some
embodiments, power sources 603, wires, communication devices, etc.
may be removable and/or replaceable (in some embodiments, one or
more of these devices may be permanently affixed to animal cage
117). Removable and replaceable power and data components may allow
for racks 405 to integrate with pumps 101 and/or medical or
monitoring devices while, when removed, allowing for cleaning and,
when replaced, reuse of racks 405 and the power and data
communication components. Data hubs 601 may reduce workspace
clutter (wired and/or wireless) and may reduce the risk of data
transmission interference between various devices.
[0056] FIG. 8 illustrates an embodiment of a box communication
arrangement with pump 101 and/or medical or monitoring devices
respectively connected (e.g., directly connected or connected
through a separate piece of hardware) to a removable piece of
wireless communications hardware (e.g., box 205) allowing for
wireless bi-directional communication between pump 101 and/or
medical or monitoring devices on animal cages 117 and computer
system 201. In some embodiments, boxes 205 (e.g., boxes 205e, 205f,
205g, and 205h) may be distributed to several devices. In some
embodiments, one or more boxes 205 may be shared by multiple
devices. In some embodiments, rack 405 may include multiple cages
117 with integrated DC power ports and a universal, removable power
supply (other configurations are also contemplated).
[0057] In some embodiments, a graphical user interface (GUI) (e.g.,
a browser-based GUI) may be used to allow operator 401 to configure
pumps 101 and/or medical or monitoring equipment (e.g., see FIGS.
9-14) through computer system 201 (or, for example, through remote
computers 209a,b,c or 215a,b,c). The GUI may also allow
configuration of the network which may include pumps 101,
communications hardware (e.g., wireless communications hardware for
networking pumps 101 to computer system 201), computer system 201
(e.g., including programming and data collection software), and a
network of remote computers (e.g., computers 209a,b,c) linked to
computer system 201 via Internet 211 and, for example, a network of
remote computers (e.g., computers 215a,b,c) linked to computer
system 201 via server 207. Other network configurations are also
contemplated. As seen in FIG. 9, a GUI may be provided to assist
operator 401 (e.g., a study director, technician, etc.) to set up a
study. Information entered into the GUI may be used, for example,
by computer system 201 to store information about the study,
control the study, etc. As seen in FIG. 10, operator 401 may set up
a password and specify other security parameters for the study. As
seen in FIG. 11, various pumps used in the study may be set-up
(e.g., communication paths may be established and/or tested between
the pumps 101 and computer system 201). As seen in FIG. 12,
different operators 401 may be added to a study (e.g., granted
access to perform actions on pumps 101 and other equipment,
document actions performed, etc). User identifiers 1201 may also be
assigned to respective operators 401. As seen in FIG. 13a, operator
401 may assign respective pumps 101 to respective animals 103 (or
vice versa). For example, computer system 201 may poll pumps 101
coupled to network 203 and pumps 101 may respond, for example, with
a pump ID (see, for example, pump IDs on the left side of FIG.
13a). In some embodiments, computer system 201 may access
respective animal IDs (e.g., from a data file, from animal RF
identification chips scanned from animals 103, manually from
operators 401 (e.g., reading animal tattooed IDs), etc). The animal
IDs may also be listed (e.g., see the right side of FIG. 13a). In
some embodiments, operator 401 may assign the animal IDs to their
respective pumps 101. For example, the animal ID on the right side
of the screen may be dragged and dropped onto the corresponding
pump ID of respective pump 101 from which respective animal 103 is
receiving substance 119. In some embodiments, pump IDs and/or
animal IDs may be related to each other by operator 401 (e.g., by
entering respective IDs in text boxes of the graphical user
interface). In some embodiments, RFID readers assigned to
respective cages 117 may scan RF animal ID chips and send the
animal ID back to computer system 201 along with the respective
pump ID for respective pump 101 providing substance 119 to cage 117
with animal 103 having the respective animal ID. Other assignment
processes are also contemplated. As seen in FIGS. 13b-14, operator
401 may navigate the GUI to check on a status of pumps 101 and
other equipment in the study, send instructions to pumps 101 and
other equipment in the study, etc.
[0058] FIG. 17 illustrates a flowchart of a method for controlled
delivery rate determination and global command rate distribution,
according to an embodiment. It should be noted that in various
embodiments of the methods described below, one or more of the
elements described may be performed concurrently, in a different
order than shown, or may be omitted entirely. Other additional
elements may also be performed as desired.
[0059] At 1701, animal weight data may be received (e.g., by
computer system 201, box 205, etc). In some embodiments, weight
data may be received from weight scale 217. Weight scale 217 may be
integrated into animal cage 117 (e.g., coupled to animal cage 117
or to tether 115 for passive automatic weight data collection) or
may be external (e.g., animal cage 117 may be placed on top of (or
hung from) weight scale 217 by operator 401). In some embodiments,
multiple pumps 101 may be associated with a specific weight scale
217 (e.g., 10 pumps 101 assigned to one weight scale 217 physically
located nearby). For example, operator 401 may place each animal
103 (e.g., in turn) associated with the pumps 101 on the weight
scale 217 for measurement (or may place respective animal 103 from
pump 101 on weight scale 217). In some embodiments, weight data
from weight scale 217 may be communicated to computer system 201.
For example, computer system 201 may receive weight data from
weight scale 217 through data hub 601 and/or box 205 coupled to
weight scale 217. As another example, weight scale 217 may be
coupled to pump 101 and weight data from weight scale 217 may be
sent to pump 101 (or box 205 coupled to pump 101) for communication
to computer system 201. In some embodiments, the weight data may be
automatically communicated to computer system 201 and stored in a
database (e.g., an operator's project software database). In some
embodiments, the weight data may be sent to computer system 201
when an instruction is received by weight scale 217 or pump 101
(e.g., from operator 401). As another example, in some embodiments,
the weight data may be sent in response to a query from computer
system 201. Other weight data sources are also contemplated. For
example, animal weight data may be received from a customer
database on a server, from a database in a computer hosting
infusion system, etc. Computer system 201 may query a database for
the weight data to be imported into computer system 201. In some
embodiments, operators 401 may load the data directly into computer
system 201 (e.g., by inserting a Compact Disc (CD) with the weight
data, manually entering the weight data, etc). In some embodiments,
new weight data may be received as new animal weights are
determined. For example, animals 103 may be weighed continuously or
at intervals (e.g., animal 103 may be weighed daily, weekly,
monthly, etc). In some embodiments, animal weights and respective
animal weights may not be determined (e.g., if the controlled
delivery rates are not weight based).
[0060] At 1703, the weights for respective animals 103 may be
determined. Animals 103 may be associated with specific pumps 101
and computer system 201 may associate weight data with respective
pumps 101. For example, if weight scale 217 is coupled to or
assigned to one respective pump 101, the weight data received from
that weight scale 217 may be associated (e.g., in a database) with
animal 103 at that respective pump 101. In some embodiments, (e.g.,
if multiple pumps 101/cages 117 are assigned to weight scale 217)
identifiers (e.g., entered by operator 401 into weight scale 217,
scanned by an RFID scanner when animal 103 with an embedded RFID
chip containing the identifier is placed on weight scale 217, etc.)
may be sent with the weight data to computer system 201 as the
animals 103 (or cages 117, etc.) are weighed to associate the
received weight data with the respective animal 103/pump 101. In
some embodiments, identifiers may be stored in the database with
the weight data to associate the weight data with respective
animals 103 and/or pumps 101 (respectively assigned to animals
103). In some embodiments, identifiers may not be used. For
example, weight data may be associated with respective animals 103
according to an order the weights were entered (which may
correspond to a predetermined order of pumps 101 in relationship to
the weight scale 217). For example, 10 pumps 101 may be assigned to
a weight scale at the end of the row of pumps 101. When the animals
103/cages 117 are weighed, operator 401 may always start with the
cage farthest from weight scale 217 and proceed down the line of
cages 117 to the cage nearest weight scale 217 (computer system 201
may be aware of the order of cages 117 and may assign the weights
to respective animals 103 according to the order the weights were
received. Other weight associations are also contemplated. The
animal 103 may be weighed on weight scale 217 directly or, for
example, cage 117 and be weighed and the animal's weight may be
derived (e.g., by subtracting a predetermined weight of the empty
cage). Other weight data sources are also contemplated (e.g., the
weight data may be imported from a separate software program or
database, manually entered, etc).
[0061] At 1705, controlled delivery rate group determinations may
be made for the respective animals 103. In some embodiments,
animals 103 may be assigned to different study groups (e.g., high
dose group, mid-dose group, low dose group, and control, etc).
Group assignments may be downloaded to computer system 201 (e.g.,
from an external computer), manually entered (e.g., by operator
401), or determined according to criteria (e.g., entered by
operator 401). For example, operator 401 may specify 1000 cages
will be used in the study and 25% are to be assigned to a high dose
group, 25% to a mid dose group, 25% to a low dose group and 25% to
a control group. This criteria may also be downloaded from an
external source. Computer system 201 may have access to (or may
determine) which pumps 101 are currently communicatively coupled to
computer system 201 (e.g., through a broadcast query and subsequent
pump responses) and the pumps 101 may be initially assigned to
different respective groups (e.g., computer system 201 may
determine and store assignments in a database for later access). In
some embodiments, respective controlled delivery rates (e.g.,
[dose/time]/kg.times.animal weight ([ml/hr]/kg.times.kg of animal
weight)) may be associated with respective groups of animals. For
example, the respective controlled delivery rates may be downloaded
from an external source, manually entered by operator 401, etc.
Additional study parameters may also be received and/or determined.
For example, an amount of time to deliver the respective doses may
also be received (e.g., downloaded from an external source,
manually entered by operator 401, etc). For example, computer
system 201 may receive and store an indication that the specified
controlled delivery rates are to be delivered for one hour a day.
Computer system 201 may also receive the total trial length (e.g.,
30 days). In some embodiments, complex profiles may be received
(e.g., controlled delivery rate for one hour per day for 15 days
and 2 hours per day for 15 days). Other profiles are also
contemplated. Computer system 201 may store controlled delivery
rates, time periods, profiles, etc. to be used in determining
controlled delivery rate for respective animals 103 in the
study.
[0062] At 1707, the controlled delivery rate for animal 103 may be
determined based, for example, on the animal's weight and the
controlled delivery rate group determination (e.g., the controlled
delivery rate assigned to the animal's group). For example, for a
specific animal 103 in a high dose group, a predetermined
controlled delivery rate of [100 ml/hr]/kg.times.kg of body weight
may be assigned (e.g., by computer system 201 based on received
data). In this example, if the weight data for the specific animal
103 indicates the specific animal 103 weighs 0.7 kg, the controlled
delivery rate for a pump 101 pumping substance 119 to the specific
animal 103 is [100 ml/hr]/kg * 0.7 kg=70 ml/hr. Computer system 201
may also use the received time periods to determine a dose per time
period of delivery. For example, study parameters may specify the
high dose group should receive the specified controlled delivery
rate for 1 hour a day. In the above example, computer system 201
may then prepare a profile with instructions for respective pump
101 to deliver 70 ml of substance 119 to respective animal 103 for
one hour every 24 hours. Study parameters may also specify the
animals 103 are to receive saline solution during the hours animals
103 are not receiving substance 119 in order that the positive
saline flow reduces the risk of catheter clotting. Other controlled
delivery rate calculations are also contemplated for the other
groups (e.g., mid dose, low dose, etc). Other time periods may also
be used (e.g., 2 hrs/day, 2 min/day, 1 hour every 3 days, etc). In
some embodiments, computer system 201 may determine multiple
respective profiles with instructions for respective animals in the
study according to their respective weights and their respective
dose groups.
[0063] At 1709, the profiles for respective animals 103 may be
delivered to the respective pumps 101. In some embodiments, the
profiles may include respective controlled delivery rates, relevant
time periods for delivery (e.g., indicating number of hours every
24 hours for delivery and total study period), start/stop times,
etc. In some embodiments, a global command may instruct computer
system 201 to send the multiple profiles to their respective pumps
101 (e.g., in some embodiments, all of the pumps 101 in the study
may receive their specific profile from computer system 101). In
some embodiments, a subset of pumps 101 may be sent their
respective profiles in response to the global command (e.g., the
global command may instruct computer system 201 to send profiles to
pumps 101 in the high dose group). As another example, the global
command may instruct computer system 201 to send profiles to pumps
101 with animals in a certain weight group (e.g., with animals 103
having weights between 0.5 kg and 0.6 kg) or to animals of a
certain gender (e.g., all male animals). Other groups are also
contemplated. In some embodiments, multiple groups may be specified
(e.g., profiles may be sent to the low dose group and the placebo
group in response to receiving the global command). In some
embodiments, multiple profiles may be pushed to their respective
pumps 101 after performing a sequence of calculations (e.g., by
computer system 201) to generate the multiple profiles. In some
embodiments, operator 401 may indicate when to send the profiles
(e.g., by pressing a button (or by some other input) on computer
system 201 (e.g., to select an on screen menu item), sending a
command to computer system 201 from a remote device, etc). As part
of the global command, operator 401 may also specify which groups
(or, for example, all of the pumps 101) to send profiles. In some
embodiments, computer system 201 may deliver infusion rate commands
(e.g., including controlled delivery rates based on the animals
weight and determined group weight-based controlled infusion rates)
to pumps 101 individually instead of in groups.
[0064] Other global commands are also contemplated. For example, a
global command may instruct computer system 201 to send other
instructions to multiple pumps 101 and/or medical or monitoring
devices on the network. For example, the global command may cause
computer system 201 to send other instructions to pumps 101 instead
of or in addition to inputting commands (e.g., by operator 401) to
pumps 101 on a one-by-one basis. In some embodiments, the global
command may instruct computer system 201 to send inquiries to pump
101, a group of pumps 101, or all of pumps 101 in the study. For
example, upon receiving an indication from operator 401, computer
system 201 may request information from a group of pumps 101 (such
as current amount of delivery time remaining, last calibration
date, etc). In some embodiments, the global command may reduce the
manpower needed to perform and send the calculations, reduce manual
calculation errors, and reduce manual data input errors. In some
embodiments, the global command may be used to automate scheduling
to reduce scheduling errors by including start/stop times with the
profiles delivered to respective pumps.
[0065] In some embodiments, the instructions for determining a
controlled delivery rate may be included in box 205 (or, for
example, internally to pump 101). Pumps 101 may determine their
respective controlled delivery rate based on the stored
instructions, the animal weight (e.g., received at pump 101 from
weight scale 217), and other information (e.g., the dose/body
weight for animal 103 associated with respective pump 101, times
for delivery, etc). In some embodiments, pumps 101 may perform the
calculations to determine their own controlled delivery rates
(e.g., computer system 201 may send a global command to pumps 101
to calculate their controlled delivery rates). In some embodiments,
the calculated controlled delivery rates (and, for example, animal
weight data) may be sent by pumps 101 to computer system 201 (e.g.,
for storage and/or validation). Other locations for controlled
delivery rate determination are also contemplated.
[0066] FIG. 18 illustrates a flowchart of a method for pump
validation, according to an embodiment. It should be noted that in
various embodiments of the methods described below, one or more of
the elements described may be performed concurrently, in a
different order than shown, or may be omitted entirely. Other
additional elements may also be performed as desired.
[0067] At 1801, computer system 201 may receive an indication of an
acceptable validation deviation. For example, operator 401 may
indicate that an acceptable validation deviation of +/-1% of actual
syringe weight difference (before and after substance delivery)
compared to calculated syringe weight difference (based on pump
determined substance delivery and substance density) is acceptable.
In some embodiments, the acceptable validation deviation may be
received from other sources (e.g., downloaded from a remote
computer). Acceptable validation deviations may also be specified
in other terms. For example, an acceptable validation deviation may
include +/-X % of actual controlled delivery rate (e.g., determined
using the difference in syringe weights, density of substance 119,
and start/stop times from pump 101) compared to provided/calculated
controlled delivery rate (e.g., the controlled delivery rate
provided to pump 101). Other acceptable validation deviations are
also contemplated. Acceptable validation deviations may be provided
in non-percent indicators. For example, operator 401 may be
prompted to enter an acceptable validation deviation as a
difference in weight (e.g., +/-X ml) between the actual volume
output and the provided/calculated volume output (e.g., X=actual
volume-volume provided to pump 101 in profile instructions). Other
sources of acceptable validation deviations are also contemplated.
In some embodiments, a range of acceptable validation deviations
may be received.
[0068] At 1803, computer system 201 may receive a beginning syringe
weight. In some embodiments, operator 401 may place syringe 109 on
weight scale 217 prior to delivering substance 119. For example,
operator 401 may place syringe 109 for pump 101 on a shared weight
scale 217 (e.g., shared with other pumps 101). In some embodiments,
the weight (and, for example, a pump identifier) may be sent to
computer system 201 by weight scale 217. In some embodiments,
weight scale 217 may be built into pump 101 to weigh syringe 109
without syringe 109 having to be removed from pump 101 (the weights
(and/or weight difference) may be sent to computer system 201 by
pump 101).
[0069] In some embodiments, operator 401 may be prompted to enter a
beginning syringe weight. For example, operator 401 may enter the
weight into computer system 201 or into pump 101 (e.g., for
delivery to computer system 201). For example, operator 401 may
place syringe 109 on weight scale 217, see weight of syringe 109
(e.g., on a display of weight scale 217), and may enter the weight
in, for example, pump 101 associated with animal 103 or computer
system 201. Other sources of the beginning syringe weight are also
contemplated. In some embodiments, weight scale 217 on, in, or
proximate to animal cage 117 or pump 101 (e.g., one weight scale
217 per pump 101 or animal cage 117 or one weight scale 217 per a
group of pumps 101 or animal cages 117) may communicate weights of
syringe 109 to computer system 201 (e.g., through box 205 coupled
to the weight scale 217). For example, weight scale 217 may
determine a weight of syringe 109 prior to delivering substance 119
to animal 103.
[0070] At 1805, computer system 201 may receive an ending syringe
weight. In some embodiments, weight scale 217 may determine a
weight of syringe 109 after delivering substance 119 to animal 103
(e.g., operator 401 may place syringe 109 on weight scale 217 after
the delivery time period or weight scale 217 may be built into pump
101). In some embodiments, operator 401 may be prompted to enter
ending syringe weight. For example, operator 401 may place syringe
109 on weight scale 217, see weight of syringe 109 (e.g., on a
display of weight scale 217), and may enter the weight in, for
example, pump 101 associated with animal 103 or computer system
201. Other sources of the ending syringe weight are also
contemplated.
[0071] At 1807, computer system 201 may compare the actual volume
output (determined using the substance density and the difference
in the beginning syringe weight and the ending syringe weight) to a
nominal volume output (e.g., an expected volume output based on the
calculated controlled delivery rate delivered to pump 101 by
computer system 201 prior to delivery).
[0072] At 1809, computer system 201 may compare the actual
controlled delivery rate (e.g., using substance density, difference
in the beginning syringe weight and the ending syringe weight and a
received actual start time and end time from pump 101) to a nominal
controlled delivery rate (e.g., based on the calculated controlled
delivery rate delivered to pump 101 by computer system 201). In
some embodiments, computer system 201 may receive a start and stop
time (or, for example, a total time of delivery) to use with the
received weights to calculate the pump's actual controlled delivery
rate. In some embodiments, computer system 201 may compare an
actual controlled delivery rate (e.g., ((beginning syringe
weight-ending syringe weight)/substance density/(stop time-start
time)) to a calculated/provided delivery controlled delivery rate
(e.g., calculated by computer system 201 prior to substance
delivery and provided to pump 101 as the respective controlled
delivery rate for respective animal 103) to determine an accuracy
of pump 101. Other information may also be sent to computer system
201 (e.g., a controlled delivery rate determined locally by pump
101). Other controlled delivery rate determination calculations are
also contemplated. For example, computer system 201 or pump 101 may
use a displacement volume and delivery time to determine an actual
controlled delivery rate. The displacement volume may be determined
using dimensions of syringe 109 (e.g., radius of a cylindrical
syringe) and, for example, the amount of plunger displacement
(e.g., indicated by a sensor on pump 101) (where displaced volume
may equal the amount of displacement * internal area (e.g., .pi. *
radius.sup.2). The actual controlled delivery rate may be
represented by the displaced volume over time of displacement
(e.g., as determined by start and stop times). In some embodiments,
information such as the dimensions of syringe 109 may be received
by computer system 201 (e.g., from pump 101 detecting a diameter of
syringe 109, operator 401, or other external source).
[0073] At 1811, computer system 201 may determine if the
comparisons of the actual volume output to the nominal volume
output and/or the comparisons of the actual controlled delivery
rate to the nominal controlled delivery rate fall within the
acceptable validation deviation (e.g., as determined/received at
1801). For example, the actual controlled delivery rate may be
compared to the nominal controlled delivery rate (e.g., the
controlled delivery rate provided to pump 101 by computer system
201 for the corresponding time period (or, for example, the
controlled delivery rate calculated by pump 101 for the
corresponding time period)). In some embodiments, comparison may
include subtracting the actual volume output from the nominal
volume output (or vice versa) and comparing the difference to an
acceptable validation deviation (which may include a range of
acceptable differences between the actual volume output and the
nominal volume output). In some embodiments, comparison may include
subtracting the actual controlled delivery rate from the nominal
controlled delivery rate (or vice versa) and comparing the
difference to an acceptable validation deviation (which may include
a range of acceptable differences between the actual controlled
delivery rate and the nominal controlled delivery rate). Other
statistical comparisons are also contemplated. As another example,
the weight (or, for example, volume) of actual substance 119
delivered (collected infusate) may be plotted versus time along
with a plot of the weight (or, for example, volume) of substance
119 that would be delivered versus time according to the nominal
controlled delivery rate. In some embodiments, operator 401 may
review the plots for semi-automatic validation. In some
embodiments, accuracy may be provided as a +/-X % accuracy (e.g.,
representative of the difference between the actual controlled
delivery rate and the nominal controlled delivery rate). In some
embodiments, the validation may be fully automatic (e.g., computer
system 201 may compare statistics of the validation against
acceptable validation ranges). In some embodiments, indications of
the success or failure of validation may be presented to operator
401. For example, accuracies falling out of the acceptable ranges
may be reported (e.g., to operator 401) as pump 101 failing
validation. Validation may be performed prior to (e.g., with a
dummy substance 119), during (e.g., with the actual substance 119
delivered to animal 103), and/or after a lab animal infusion study.
In some embodiments, each pump 101 may be validated or a sampling
of pumps 101 may be validated. In some embodiments, if pump 101
fails validation, pump 101 may not be used until successfully
validated. In some embodiments, automated validation may reduce the
manpower needed to perform and send the calculations, reduce manual
calculation errors, and reduce manual data input errors. In some
embodiments, the validations may be performed according to an
automated schedule to reduce scheduling errors. In addition,
automated validations may allow for an increased validation
frequency (e.g., pumps 101 may be validated before a study, one or
more times during the study, and after the study).
[0074] In some embodiments, pumps 101 may be calibrated (e.g., on a
regular basis such as once a year). Calibration may include testing
controlled delivery rate accuracy over a period of time (e.g.,
comparing actual pump controlled delivery rate to instructed pump
controlled delivery rate). Calibration may further include
comprehensive periodic checks to confirm proper pump functioning
(e.g., several aspects of pump 101 may be checked with sensors,
etc. to insure proper functioning). In some embodiments,
information related to the next calibration may be stored, for
example, on computer system 201, pump 101, box 205, etc.
Calibration information may include a date pump 101 was last
calibrated, a next date pump 101 should be calibrated by, etc.
Calibration information may be stored, for example, in firmware in
pump 101 (or, for example, coupled to pump 101 (such as in memory
305)). Calibration information may also be included on an outside
of pump 101 (e.g., written on a pump label). Computer system 201
(or executable instructions on box 205, etc.) may check the
calibration information (e.g., prior to the beginning of a study)
and may indicate (e.g., to operator 401) pumps 101 that have
surpassed their calibration interval (or will surpass their
calibration interval during the study). For example, if the
calibration dates are stored at pumps 101, computer system 201 may
poll pumps 101 in the network for their calibration dates to
determine if any of pumps 101 are outside of their calibration
period or will be outside the calibration period at any time during
the next study. In some embodiments, computer system 201 (or, for
example, box 205) may prevent use of pump 101 until pump 101 is
calibrated and the information stored for pump 101 indicates that
the calibration is current. In some embodiments, a calibration
database may include pump identifiers and respective calibration
dates for pumps 101 (e.g., the calibration dates may not be stored
in the pumps 101). In some embodiments, operators 401 may read
calibration information on pump 101 (e.g., on an outer label) and
may enter the calibration information into an interface on pump 101
and/or computer system 201 to be stored. Computer system 201 may
poll pumps 101 to determine pump identifiers (indicating which
pumps 101 are currently coupled to the network) and compare this
list of pumps 101 to the calibration database to determine if the
current pumps 101 have current calibration dates. Computer system
201 may alert operator 401 as to which pumps 101 have calibration
problems to allow operator 401 to replace and/or calibrate the
problem pumps 101. In some embodiments, computer system 201 (or,
for example, box 205) may calibrate pump 101 (e.g., using
techniques described above). Other calibration techniques are also
contemplated. Automating the calibration check may save time,
assure compliance with documentation requirements, and reduce the
risk of human error.
[0075] FIG. 19 illustrates a flowchart of a method for automated
syringe filling, according to an embodiment. It should be noted
that in various embodiments of the methods described below, one or
more of the elements described may be performed concurrently, in a
different order than shown, or may be omitted entirely. Other
additional elements may also be performed as desired.
[0076] At 1901, syringe 109 to be filled may be loaded onto pump
101. For example, computer system 201 may instruct operator 401 to
load syringe 109 onto a filling pump (which may be a pump 101). In
some embodiments, computer system 201 may instruct operator 401 to
attach a vat holding substance 119 to be loaded into syringe 109 to
pump 101 (or the vat may already be attached to syringe 109 on pump
101). In some embodiments, pumps 101 at animal cages 117 may fill
syringe 109 (e.g., operator 401 may carry the vessel from pump 101
to pump 101 and the filling instructions may be sent by computer
system 201 to respective pump 101). For example, pump 101 may be a
bi-directional pump 101 capable of pulling the appropriate fluid
volume into syringe 109 (e.g., by pulling plunger of syringe 109 to
fill syringe 109). In some embodiments, pump 101 for filling
syringe 109 may be located next to respective animal cage 117 or
may be a separate pump 101 (e.g., communicatively coupled to
computer system 201 but not necessarily at animal cage 117).
[0077] At 1903, computer system 201 may determine an amount of
substance 119 to be filled into syringe 109. For example, computer
system 201 may determine an amount of substance 119 needed for a
next round of delivery for a respective animal 103 (e.g., based on
a controlled delivery rate assigned to animal 103). In some
embodiments, computer system 201 may determine an amount of
substance 119 to be delivered by pump 101 during a next phase of
the study and the amount may be communicated to pump 101.
[0078] At 1905, filling pump 101 may fill syringe 109 with the
amount of substance 119 directed by computer system 201. For
example, pump 101 may pull the syringe plunger backward to aspirate
fluid (e.g., substance 119) from a vessel into syringe 109 until
the directed amount is in syringe 109. In some embodiments, the
filling pump 101 may operate in a reverse direction of pumps 101
delivering substance 119 to animal 103 (e.g., at the animal cages
117). Pump 101 may aspirate an appropriate volume of substance 119
on an animal-by-animal (pump-by-pump) basis (e.g., for different
syringes 109). In some embodiments, operator 401 may instruct pump
101 (e.g., at animal cage 117) to enter a filling mode and pump 101
may receive data from computer system 201 for the proper fill
amount. In some embodiments, pump 101 may be controlled by computer
system 201 (or, for example, box 205 coupled to pump 101) to load
syringe 109 with a predetermined amount of substance 119. Pump 101
and/or computer system 201 may also specify to operator 401 what
type of substance 119 to load into syringe 109 (and operator 401
may attach the appropriate vat of substance 119). In some
embodiments, operator 401 may receive an indicator such as "Vat A"
instead of or in addition to the specific type of substance 119 to
load into syringe 109 (e.g., in a blind study). In some
embodiments, syringe 109 may be loaded several times a day.
[0079] At 1907, an indicator may be provided on syringe 109. For
example, operator 401 may write the animal identification (ID)
(e.g., of the respective animal to receive the substance) and
sequence of use data on syringe 109. As another example, an
attached printhead may apply the data onto syringe 109 (e.g.,
automatically and/or by operator 401) (which may be printed
directly on the syringe 109 or on a label to be coupled to the
syringe 109). In some embodiments, operator 401 may apply a label
generated by an attached label printer. In some embodiments, a
printer (e.g., coupled to computer system 201, pump 101, etc.) may
print a label for syringe 109 (e.g., with a pump identifier, the
substance type, amount, animal identifier, etc.) Other information
may also be printed onto the label. The label may be attached to
syringe 109 (e.g., by operator 401). In some embodiments, a
separate pump 101 may be used to fill syringes 109 (e.g., at a
dedicated filling station (which may also have a printer)). Other
filling techniques are also contemplated. Automating filling the
syringe may decrease manpower needed to fill the syringe, reduce
manual calculation errors and reduce manual data input errors.
[0080] In some embodiments, computer system 201 may display and/or
print out a list (e.g., list 1505 in FIG. 15b) of dosages for
future syringes 109. For example, computer system 201 may determine
a dosage amount needed for multiple syringes 109 based on the
respective animal weights, dosage ratios, etc. The dosage (e.g., a
substance volume) for each syringe 109 may be displayed and/or
printed with an identifier for pump ID, animal ID 103, dosage,
approximate time/day for next syringe change, syringe type (e.g.,
syringe volume), etc. The displayed or printed list 1505 may allow
operator 401 to pre-load syringes 109 in advance (e.g., without
performing additional calculations). In some embodiments, animals
103 may be reweighed weekly (or other time interval) and the future
syringes 109 for a week may be displayed (beyond a week, computer
system 201 may need a new weight for animal 103 and therefore, may
not be able to provide a listing past the current week). Other
weigh in times (e.g., continuous, once a day, once a month, etc.)
are also contemplated. The future syringe print outs may reduce
manpower needed to perform the calculations, reduce manual
calculation errors, and reduce manual data input errors.
[0081] In some embodiments, pump 101 may measure a size of syringe
109 (e.g., may detect a diameter of syringe 109). Pumps 101 may
include a mechanism for determining a diameter of a loaded syringe
109 (e.g., a lever arm coupled to a gear to measure the diameter of
syringe 109). In the lever arm example, the gear may detect a
displacement of the lever arm when syringe 109 is placed between
the lever arm and pump 101. Other diameter detections are also
contemplated. A study may use a syringe of saline solution in an
intermittent infusion profile (or a KVO (Keep Vein Open) solution
to prevent catheter clotting) and a different sized syringe for a
test article (TA) solution (e.g., the new chemical entity to be
tested). Syringe 109 with the KVO solution may have a larger
diameter than syringe 109 for the test solution. For example, the
KVO solution syringe may be a 20 cubic centimeter (cc) syringe used
to deliver saline solution to animal 103 for 23 hours and the test
solution syringe may be a 5 cc syringe used to deliver a test
solution to animal 103 for one hour. Other sizes and times are also
contemplated. In some embodiments, pump 101 may detect the size
(e.g., diameter and/or length) of syringe 109 in pump 101 and, if
syringe 109 size does not correspond to syringe 109 that pump 101
is assigned to be pumping (e.g., as noted by instructions from
computer system 201 stored, for example, in the box memory), pump
101 may give operator 401 an indicator, sound an alarm, and/or not
pump syringe 109. Pump 101 may reduce human loading error to insure
compliance with the provided infusion profile. In some embodiments,
operator 401 may input information about syringe 109 (e.g., type of
syringe, brand of syringe, size of syringe, syringe identifier,
etc.) into pump 101 and/or computer system 201. The information may
be stored and/or used to verify that the correct syringe 109 has
been loaded.
[0082] FIG. 20 illustrates a flowchart of an embodiment for study
documentation. Computer system 201 may communicate with pumps 101
and/or other medical or monitoring devices involved in the study to
document events occurring in the study (e.g., start times, stop
times, alarms, how alarms were cleared, animal weights, amount of
feed/water consumed, etc). These events may also be stored with
respective user identifiers 1201 to identify operators 401
associated with the events (e.g., to identify operator 401 who
cleared an alarm). The documentation may be used to support the
validity of the study. It should be noted that in various
embodiments of the methods described below, one or more of the
elements described may be performed concurrently, in a different
order than shown, or may be omitted entirely. Other additional
elements may also be performed as desired.
[0083] At 2001, user identifier 1201 may be received at computer
system 201. In some embodiments, operator 401 may enter user
identifier 1201 (e.g., an identifier such as a PIN code or, for
example, a pre-assigned (by computer system 201) alpha numeric user
code unique to operator 401) into pump 101 and/or medical or
monitoring device. Other user identifiers 1201 are also
contemplated (e.g., operator 401 may enter their name as user
identifier 1201, scan a bar code (e.g., on the operator's uniform),
swipe a magnetic card with user identifier 1201, biometric scan
(e.g., scanning an user's thumbprint or retina), Radio Frequency
Identification (e.g., transmitted from a PDA, etc)). User
identifier 1201 may be sent to computer system 201 for storage
relative to the actions performed by (or other documentation
submitted by) operator 401. For example, in responding to an alarm,
operator 401 may enter user identifier 1201 (e.g., into the pump
interface or into computer system 201) assigned to that operator
401 prior to taking action to correct the alarm. The alarm may be
indicated on computer system 201 and/or a communication (such as an
email, short message service (SMS), etc.) may be sent to operator
401. The communication may include a pump identifier and an alarm
type indicator (e.g., indicating why the alarm sounded). For
example, if a pressure transducer on pump 101 detects an occlusion
in the delivery tube, pump 101 may indicate an alarm and send a
communication.
[0084] At 2003, operator 401 may be authenticated based on the
received user identifier 1201. In some embodiments, user identifier
1201 may be used by pump 101 (or, for example, computer system 201,
etc.) to authenticate operator 401 prior to allowing operator 401
to take action on pump 101. User identifier 1201 may thus act as
user stamp/e-signature for the actions taken by operator 401. In
some embodiments, operator 401 may be authenticated prior to taking
action on other devices (e.g., computer system 201, medical
devices, monitoring devices, animal cage 117, etc). In some
embodiments, authentication may include comparing the received user
identifier 1201 to user identifiers 1201 stored in an
authentication database. Other authentication is also contemplated.
In some embodiments, user identifiers 1201 may be changed for each
study (e.g., by a study administrator who may set up which
operators 401 are authorized to interact with the study
equipment).
[0085] At 2005, computer system 201 may receive a documentation
indicator associated with pump 101 (or other equipment). For
example, documentation indicators (e.g., see documentation
indicator 1601 in FIG. 16) may correspond to events (such as
starting pump 101, responding to an alarm, stopping pump 101, etc.)
and actions taken by operators 401 in response to the events.
Documentation indicators 1601 may also correspond to information
related to general and/or specific observations by operator 401
(e.g., animal 103 is sick) which may or may not be event specific.
Documentation indicators 1601 may include a cause of an alarm.
Alarms (e.g., as discussed above) may occur when equipment (e.g.,
pump 101) or other variables (e.g., health conditions of animal
103) in the study encounter a problem. For example, pump 101 may
encounter a problem such as occlusion in delivery tube 105, low
battery, no power, empty syringe, etc. When problems occur, an
alarm may sound (or in some way be indicated to operator 401).
Actions taken to clear an alarm may be entered (e.g., by operator
401 into a graphical interface on pump 101 or computer system 201)
and a corresponding documentation indicator 1601 may be assigned.
In some embodiments, operator 401 may be presented with menu (e.g.,
a drop down menu) and other options at computer system 201 and/or
pump 101 (operator may have flexibility to document the event
and/or enter other information (e.g., observations and/or non-event
related information) at pump 101 or computer system 201). The menu
may be specific to the type of alarm encountered. For example, if
an alarm is triggered because of a kinked delivery tube, the alarm
menu provided to operator 401 may include options for how the
kinked delivery tube was fixed (e.g., "1: Tube unkinked"; "2: Tube
replaced"; "3: Other"). In some embodiments, pump 101 may determine
what caused the alarm, the actions taken by operator 401 to fix the
alarm, etc. and may transmit appropriate documentation indicators
1601 to computer system 201. In some embodiments, operators 401 may
enter documentation indicators 1601 indicative of what caused the
alarm, the actions taken to clear the alarm, etc. into a pump
interface (and/or computer system interface). Other interfaces are
also contemplated (e.g., operators 401 may enter documentation
indicators into a PDA which may transmit the documentation
indicators 1601 to computer system 201 and/or pump 101 (e.g., to be
transmitted to computer system 201)). Documentation indicators 1601
may also be stored relative to events not corresponding to an
operator's actions (e.g., documentation indicator 1601 may be
stored to indicate the occurrence of the alarm). Documentation
indicators 1601 may be textual descriptions (e.g., "Alarm cleared
by refilling syringe"). Documentation indicators 1601 may also be
numerical or alpha-numerical (e.g., numbers or alpha numeric
entries linked to textual description, for example, through a
look-up table). Other documentation indicators 1601 are also
contemplated. In some embodiments, operators 401 may define menus
and menu selections for receiving documentation indicators. For
example, operators 401 may define a menu for a specific type of
alarm and the menu may be provided to pump 101 for presentation the
next time that alarm is triggered. Operator 401 may respond to the
alarm by entering appropriate menu selections and the information
may be stored in computer system 201 as documentation indicators
(e.g., along with the respective user identifiers 1201).
[0086] At 2007, computer system 201 may store user identifier 1201
and documentation indicator 1601. In some embodiments, computer
system 201 may store corresponding documentation indicators 1601
for the operator's actions. Operator 401 may respond to the alarm
and indicate on pump 101 (e.g., using a pump keypad and menu
options presented on the pump display) the cause of the problem
and/or how the problem was fixed. Information about the alarm, the
technician identification (e.g., user identifier 1201), how the
alarm was fixed, etc. may be entered into computer system 201 by
operator 401 or may be entered into pump 101 and relayed to
computer system 201 to be stored (e.g., in an electronic log) (see,
for example, FIG. 16). Computer system 201 may store user
identifiers 1201 with the corresponding documentation indicators
1601 (and, for example, a pump identifier or other device
identifier).
[0087] At 2009, computer system 201 (and/or pump 101 or other
equipment) may require a separate user identifier 1201 for separate
documentation indicators 1601 to be stored with the separate
documentation indicators 1601. In some embodiments, operator 401
may enter their user identifier 1201 prior to each action operator
401 takes on pump 101 (or in relationship to animal cage 117,
medical, and/or monitoring device). In some embodiments, operator
401 may be required to enter user identifier 1201 prior to any
intervention with pump 101 (or other equipment). For example, if
user identifier 1201 for operator 401 is "231" and operator 401
starts and stops pump 101, operator 401 may be required to enter
"231" prior to pressing a button to start pump 101 and enter "231"
again prior to stopping pump 101. Computer system 201 may log
documentation indicators 1601 with user identifiers 1201 (e.g.,
"231 start pump; 231 stop pump"). In some embodiments, computer
system 201 may store a time and/or date with documentation
indicators 1601. In some embodiments, computer system 201 may
prompt operator 401 for additional documentation at computer system
201. For example, in clearing an alarm, operator 401 may indicate
at pump 101 "other" for how alarm was cleared (e.g., using menu
options provided at pump 101). Computer system 201 may then blink a
screen of computer system 201, provide an alert indicator, or in
some other fashion request additional description from the operator
401 as to how the pump alarm was cleared (or for other prior pump
or equipment interactions). Operator 401 may enter one or more
phrases, sentences, etc. in a text box that may be saved with log
information for the respective pump 101. Other documentation may
also be required of operator 401 (e.g., documentation may be
requested for why pump 101 was stopped, why animal 103 was removed
from animal cage 117, etc). In some embodiments, pump 101 may
require operator 401 to enter information about the alarm (e.g.,
cause of problem, how the problem was fixed, etc.) prior to
allowing operator 401 to continue pump operations (e.g., restart
pump 101). This may force documentation of the alarm and the
solution. In some embodiments, operator 401 may select "Other" in
the menu options of the alarm. Operator 401 may then be prompted
(e.g., at computer system 201) to enter additional information
(e.g., a written statement of the problem solution) at computer
system 201. In some embodiments, operator 401 may be required to
enter the additional documentation before the pump 101 will be
allowed to resume. In some embodiments, computer system 201 may
prevent operator's future access to computer system 201 or pump 101
until the required documentation is entered. This may improve
documentation by reducing human error (intentional and inadvertent)
and enforcing compliance with protocols for documentation including
documentation requirements.
[0088] In some embodiments, a graphical profile of a substance
delivery for a respective pump 101 may be displayed by computer
system 201. For example, as seen in FIG. 15, the amount of the
substance delivered (Y axis) over time (X axis) may be plotted as
graphical profile line 1501. The Y axis may also be substance
volume/body weight and the graphical profile may represent
substance volume per weight per time unit. The graphical profile
may make it easier for operator 401 to see when the syringe changes
occur, what types of syringes are being exchanged (e.g., size of
syringes being exchanged), etc. The profile may present a preview
(e.g., which may be printed out) for one or more pumps for the
study. The graphical profile may assist operator 401 in confirming
proper infusion profile input and better visualize a sequence of
future pump activities.
[0089] In some embodiments, indicator 1503 may be displayed on the
graphical profile to indicate a current status of the substance
delivery (e.g., where in the profile the current pump 101 is in the
study (e.g., see line 1503)). Line 1503 may be in a different color
(e.g., red) than graphical profile line 1501. Other graphical
indicators 1503 are also contemplated (e.g., asterisk, arrow, etc).
In some embodiments, by viewing indicator 1503, operator 401 may be
able to graphically determine a current controlled delivery rate
and substance type being delivered by the selected pump 101
(operator 401 may also select other respective pumps 101 to view
their respective profiles). In some embodiments, indicator 1503 may
assist operator 401 in determining what point in the infusion
profile pump 101 is current operating. For example, operator 401,
upon viewing indicator 1503, may determine whether pump 101 is at a
point in the infusion profile for a KVO syringe or a TA
syringe.
[0090] FIG. 21 illustrates an embodiment of a WAN 2102 and a LAN
2104. WAN 2102 may be a network that spans a relatively large
geographical area. Internet 211 is an example of a WAN 2102. WAN
2102 typically includes a plurality of computer systems that may be
interconnected through one or more networks. Although one
particular configuration is shown in FIG. 21, WAN 2102 may include
a variety of heterogeneous computer systems and networks that may
be interconnected in a variety of ways and that may run a variety
of software applications.
[0091] One or more LANs 2104 may be coupled to WAN 2102. LAN 2104
may be a network that spans a relatively small area. Typically, LAN
2104 may be confined to a single building or group of buildings.
Each node (i.e., individual computer system or device) on LAN 2104
may have its own Central Processing Unit (CPU) with which it may
execute programs. Each node may also be able to access data and
devices anywhere on LAN 2104. LAN 2104, thus, may allow many users
to share devices (e.g., printers) and data stored on file servers.
LAN 2104 may be characterized by a variety of types of topology
(i.e., the geometric arrangement of devices on the network), of
protocols (i.e., the rules and encoding specifications for sending
data, and whether the network uses a peer-to-peer or client/server
architecture), and of media (e.g., twisted-pair wire, coaxial
cables, fiber optic cables, and/or radio waves).
[0092] Each LAN 2104 may include a plurality of interconnected
computer systems (e.g., computers 201, 215a, 215b, 215c, etc.) and
optionally one or more other devices. For example, LAN 2104 may
include one or more workstations 2110a, one or more personal
computers 2112a, one or more laptop or notebook computer systems
2114, one or more server computer systems 2116 (e.g., server 207),
and one or more network printers 2118. As illustrated in FIG. 21,
an example LAN 2104 may include one of each computer systems 2110a,
2112a, 2114, and 2116, and one printer 2118. LAN 2104 may be
coupled to other computer systems and/or other devices and/or other
LANs through WAN 2102.
[0093] One or more mainframe computer systems 2120 may be coupled
to WAN 2102. As shown, mainframe 2120 may be coupled to a storage
device or file server 2124 and mainframe terminals 2122a, 2122b,
and 2122c. Mainframe terminals 2122a, 2122b, and 2122c may access
data stored in the storage device or file server 2124 coupled to or
included in mainframe computer system 2120.
[0094] WAN 2102 may also include computer systems connected to WAN
2102 individually and not through LAN 2104. For example,
workstation 2110b and personal computer 2112b may be connected to
WAN 2102. For example, WAN 2102 may include computer systems that
may be geographically remote and connected to each other through
the Internet.
[0095] FIG. 22 illustrates an embodiment of computer system 201
that may be suitable for implementing various embodiments of a
system and method for test animal substance delivery and
monitoring. Each computer system 201 typically includes components
such as CPU 2252 with an associated memory medium such as Compact
Disc Read Only Memories (CD-ROMs) 2260. The memory medium may store
program instructions for computer programs. The program
instructions may be executable by CPU 2252. Computer system 201 may
further include a display device such as monitor 2254, an
alphanumeric input device such as keyboard 2256, and a directional
input device such as mouse 2258. Computer system 201 may be
operable to execute the computer programs to implement
computer-implemented systems and methods for test animal substance
delivery and monitoring.
[0096] Computer system 201 may include a memory medium on which
computer programs according to various embodiments may be stored.
The term "memory medium" is intended to include an installation
medium, e.g., floppy disks or Compact Disc Read Only Memories
(CD-ROMs) 2260, a computer system memory such as Dynamic Random
Access Memory (DRAM), Static Random Access Memory (SRAM), Extended
Data Out Random Access Memory (EDO RAM), Double Data Rate Random
Access Memory (DDR RAM), Rambus Random Access Memory (RAM), etc.,
or a non-volatile memory such as a magnetic media, e.g., a hard
drive or optical storage. The memory medium may also include other
types of memory or combinations thereof. In addition, the memory
medium may be located in a first computer, which executes the
programs or may be located in a second different computer, which
connects to the first computer over a network. In the latter
instance, the second computer may provide the program instructions
to the first computer for execution. Computer system 201 may take
various forms such as a personal computer system, mainframe
computer system, workstation, network appliance, Internet
appliance, PDA, television system or other device. In general, the
term "computer system" may refer to any device having a processor
that executes instructions from a memory medium.
[0097] The memory medium may store a software program or programs
operable to implement a method for test animal substance delivery
and monitoring. The software program(s) may be implemented in
various ways, including, but not limited to, procedure-based
techniques, component-based techniques, and/or object-oriented
techniques, among others. For example, the software programs may be
implemented using ActiveX controls, C++ objects, JavaBeans,
Microsoft Foundation Classes (MFC), browser-based applications
(e.g., Java applets), traditional programs, or other technologies
or methodologies, as desired. A CPU such as host CPU 2252 executing
code and data from the memory medium may include a means for
creating and executing the software program or programs according
to the embodiments described herein.
[0098] Various embodiments may also include receiving or storing
instructions and/or data implemented in accordance with the
foregoing description upon a carrier medium. Suitable carrier media
may include storage media or memory media such as magnetic or
optical media, e.g., disk or CD-ROM, as well as signals such as
electrical, electromagnetic, or digital signals, may be conveyed
via a communication medium such as a network and/or a wireless
link.
[0099] Embodiments of a subset or all (and portions or all) of the
above may be implemented by program instructions stored in a memory
medium or carrier medium and executed by a processor. A memory
medium may include any of various types of memory devices or
storage devices. The term "memory medium" is intended to include an
installation medium, e.g., a Compact Disc Read Only Memory
(CD-ROM), floppy disks, or tape device; a computer system memory or
random access memory such as Dynamic Random Access Memory (DRAM),
Double Data Rate Random Access Memory (DDR RAM), Static Random
Access Memory (SRAM), Extended Data Out Random Access Memory (EDO
RAM), Rambus Random Access Memory (RAM), etc.; or a non-volatile
memory such as a magnetic media, e.g., a hard drive, or optical
storage. The memory medium may comprise other types of memory as
well, or combinations thereof. In addition, the memory medium may
be located in a first computer in which the programs are executed,
or may be located in a second different computer that connects to
the first computer over a network, such as the Internet. In the
latter instance, the second computer may provide program
instructions to the first computer for execution. The term "memory
medium" may include two or more memory mediums that may reside in
different locations, e.g., in different computers that are
connected over a network.
[0100] In some embodiments, a computer system at a respective
participant location may include a memory medium(s) on which one or
more computer programs or software components according to one
embodiment of the present invention may be stored. For example, the
memory medium may store one or more programs that are executable to
perform the methods described herein. The memory medium may also
store operating system software, as well as other software for
operation of the computer system.
[0101] In this patent, certain U.S. patents, U.S. patent
applications, and other materials (e.g., articles) have been
incorporated by reference. The text of such U.S. patents, U.S.
patent applications, and other materials is, however, only
incorporated by reference to the extent that no conflict exists
between such text and the other statements and drawings set forth
herein. In the event of such conflict, then any such conflicting
text in such incorporated by reference U.S. patents, U.S. patent
applications, and other materials is specifically not incorporated
by reference in this patent.
[0102] Further modifications and alternative embodiments of various
aspects of the invention may be apparent to those skilled in the
art in view of this description. Accordingly, this description is
to be construed as illustrative only and is for the purpose of
teaching those skilled in the art the general manner of carrying
out the invention. It is to be understood that the forms of the
invention shown and described herein are to be taken as
embodiments. Elements and materials may be substituted for those
illustrated and described herein, parts and processes may be
reversed, and certain features of the invention may be utilized
independently, all as would be apparent to one skilled in the art
after having the benefit of this description of the invention.
Changes may be made in the elements described herein without
departing from the spirit and scope of the invention as described
in the following claims.
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