U.S. patent application number 12/202094 was filed with the patent office on 2009-03-05 for control of body fluid condition using diuretics, based on biological parameters.
Invention is credited to San Hoon Woo.
Application Number | 20090062730 12/202094 |
Document ID | / |
Family ID | 40387869 |
Filed Date | 2009-03-05 |
United States Patent
Application |
20090062730 |
Kind Code |
A1 |
Woo; San Hoon |
March 5, 2009 |
CONTROL OF BODY FLUID CONDITION USING DIURETICS, BASED ON
BIOLOGICAL PARAMETERS
Abstract
The system for controlling body fluids overcomes the limitations
of the prior art by automatically infusing diuretic and/or other
drugs into a human patient. In one approach, the rate of infusion
of the diuretic is adjusted based on a measured biological
parameter of the patient. For example, this biological parameter
can be transmitted wirelessly to a portable diuretic infusion
device attached to the patient.
Inventors: |
Woo; San Hoon; (Palo Alto,
CA) |
Correspondence
Address: |
FENWICK & WEST LLP
SILICON VALLEY CENTER, 801 CALIFORNIA STREET
MOUNTAIN VIEW
CA
94041
US
|
Family ID: |
40387869 |
Appl. No.: |
12/202094 |
Filed: |
August 29, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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60967025 |
Sep 1, 2007 |
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60979634 |
Oct 12, 2007 |
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60986974 |
Nov 9, 2007 |
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60988375 |
Nov 15, 2007 |
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61048113 |
Apr 25, 2008 |
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Current U.S.
Class: |
604/66 |
Current CPC
Class: |
A61M 5/14244 20130101;
A61M 5/16827 20130101; A61M 5/1723 20130101; A61M 2202/0496
20130101; A61M 5/14276 20130101; A61M 2205/05 20130101; A61M
2205/3569 20130101 |
Class at
Publication: |
604/66 |
International
Class: |
A61M 5/168 20060101
A61M005/168 |
Claims
1. A diuretic infusion system comprising: a biological parameter
measurement apparatus including: a biological parameter measurement
sensor for measuring a biological parameter of a human patient; and
a diuretic infusion device including: a reservoir for holding a
diuretic; a pump connected to the reservoir and connectable to the
human patient, for infusing diuretic from the reservoir into the
human patient; and a controller for controlling the pump and rate
of infusion of the diuretic based on the measured biological
parameter.
2. The system of claim 1, wherein: the biological parameter
measurement apparatus further includes a wireless transmitter for
wirelessly transmitting measured biological information; and the
diuretic infusion device further includes a wireless receiver for
wirelessly receiving the biological parameter information
transmitted by the biological parameter measurement apparatus, the
controller controlling the pump and rate of infusion of the
diuretic based on the received biological parameter
information.
3. The system of claim 1, wherein the biological parameter
measurement sensor is a patch sensor.
4. The system of claim 1, wherein the biological parameter
measurement sensor is an intracardiac pressure measurement sensor
and the controller adjusts the rate of infusion based on a measured
pressure within a cardiac chamber of the patient.
5. The system of claim 4, wherein the controller adjusts the rate
of infusion based on the measured pressure within the cardiac
chamber to maintain a target pressure in the cardiac chamber.
6. The system of claim 1, wherein the biological parameter
measurement sensor is an intravascular pressure measurement sensor
and the controller adjusts the rate of infusion based on a measured
pressure within a blood vessel of the patient.
7. The system of claim 6, wherein the controller adjusts the rate
of infusion based on the measured pressure within the blood vessel
to maintain a target pressure in the blood vessel.
8. The system of claim 1, wherein the biological parameter
measurement sensor is an intrathoracic electrical impedance
measurement sensor and the controller adjusts the rate of infusion
based on a measured intrathoracic electrical impedance.
9. The system of claim 1, wherein the biological parameter
measurement apparatus is a non-invasive blood pressure measurement
device. and the controller adjusts the rate of infusion based on a
measured blood pressure of the patient
10. The system of claim 1 wherein the biological parameter
measurement apparatus is coupled to a pacemaker.
11. The system of claim 1 wherein the biological parameter
measurement apparatus is coupled to an implantable cardioverter
defibrillator.
12. The system of claim 1 wherein the biological parameter
measurement apparatus is coupled to a cardiac resynchronization
therapy.
13. The system of claim 1, wherein the biological parameter is a
biomarket and the controller adjusts the rate of infusion based on
the measured biomarker.
14. The system of claim 13, wherein the biomarker is selected from
the group consisting of an atrial natriuretic peptide, a brain
natriuretic peptide, and a NT-pro brain natriuretic peptide.
15. The system of claim 1, wherein the system is further configured
for administering a drug selected from a group consisting of: ACE
inhibitor, calcium channel blocker, beta blocker, inotropic agent,
hydralazine, loop diuretics, thiazide diuretics, and vasopressin
receptor antagonist
16. The system of claim 1, wherein the pump is a portable pump.
17. The system of claim 1, wherein the pump is a non-portable
pump.
18. The system of claim 1, wherein the pump is an ambulatory drug
infusion pump.
19. The system of claim 1, wherein the pump is an implantable drug
infusion pump.
20. A method for infusing diuretic to a human patient comprising:
receiving non-weight biological parameter information based on
measurements of a non-weight biological parameter for a patient;
and adjusting an infusion rate of diuretic into the patient based
on the measured non-weight biological parameter according to a
predetermined protocol.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims priority under 35 U.S.C.
.sctn.119(e) to (a) U.S. Provisional Patent Application Ser. No.
60/967,025, "Apparatus and method to control body fluid balance,"
filed Sep. 1, 2007, (b) U.S. Provisional Patent Application Ser.
No. 60/979,634, "Controlling body fluid condition using diuretics,"
filed Oct. 12, 2007, (c) U.S. Provisional Patent Application Ser.
No. 60/986,974, "Controlling body fluid condition using diuretics,"
filed Nov. 9, 2007, and (d) U.S. Provisional Patent Application
Ser. No. 60/988,375, "Controlling body fluid condition using
diuretics," filed Nov. 15, 2007, and (e) U.S. Provisional Patent
Application Ser. No. 61/048,113, "Controlling body fluid condition
using diuretics," filed Apr. 25, 2008. The subject matter of all of
the foregoing is incorporated herein by reference in its entirety,
including any appendices or attachments, for all purposes.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention relates to controlling body fluid condition
using diuretics.
[0004] 2. Description of the Related Art
[0005] Body fluid imbalance is associated with many diseases such
as congestive heart failure, liver cirrhosis and kidney disease.
Congestive heart failure in particular is a major cause of death
and hospitalization. Despite currently available treatment,
mortality and hospitalization from congestive heart failure remains
high. Causes of heart failure include coronary artery disease,
hypertension, valvular heart disease, myocardial infarction, etc.
As pump function of the heart deteriorates, body fluid often
increases and may lead to complications such as pulmonary
edema.
[0006] When pumping capacity of the heart deteriorates, blood
perfusion to the kidneys decreases. This results in retention and
accumulation of body fluid because excessive body fluid is not
delivered to the kidneys to be excreted. This excessive body fluid
often manifests as swelling of the legs. If body fluid continues to
expand, a weak heart may be no longer able to handle increased
blood volume and finally fails to pump blood forward adequately.
Symptoms of congestive heart failure include shortness of breath,
fatigue, swelling of legs, orthopnea, paroxysmal nocturnal dyspnea
(not being able to breathe suddenly at night). Many people come to
the emergency room due to congestive heart failure exacerbation.
People do not breathe well when fluid builds up in the lungs.
[0007] Diuretics such as hydrochlorothiazide, furosemide and
bumetanide are often used to treat this fluid accumulation by
increasing the excretion of body fluid and sodium through the
kidneys. However, use of oral diuretics often fails to prevent
heart failure exacerbation. This failure of diuretics to prevent
heart failure can be explained by several mechanisms. First, the
dosage of oral diuretics prescribed by the doctor is often fixed,
but the ideal dosage often changes depending on changing body
conditions. For example, when people with heart disease eat salty
food high in sodium content, their body fluid may increase
significantly. We often see people come to the emergency room after
they eat excessive amount of salt at a party. In this situation,
people will require a higher dose of diuretics in order to excrete
excessive body fluid and salt. The required dose of diuretics is
affected by the dietary intake of sodium, water and tendency to
retain sodium. When body fluid builds up in the digestive system,
it may cause intestinal edema (swelling). Bioavailability of
diuretics may decrease with intestinal swelling. The body may not
be able to absorb diuretics effectively. Patients may need to take
higher dose of diuretics when poor bioavailability occurs.
[0008] Second, poor compliance plays a role. People sometimes
forget to take medications. This poor compliance could result in
heart failure. Third, treatment delay plays a role. When there is a
sign of body fluid accumulation such as swelling of legs, many
people ignore this early sign of heart failure and wait until their
condition gets severe enough to require hospitalization. These
explanations are associated with many cases of heart failure.
[0009] Sliding scale diuretic titration of oral diuretics has been
attempted for the treatment of congestive heart failure by some
heart failure management programs. In sliding scale diuretic
titration, patients are instructed to measure body weights and
adjust diuretics pill dose according to the instruction given by
their physician or nurse. However, conventional diuretic sliding
scale titration has several significant drawbacks. First, patients
may not understand the sliding scale instruction or may not comply
with it. Poor understanding of the instruction may also lead to
inappropriate use of medication. Second, conventional instructions
may be limited to instructions and sliding scale titration that are
simpler than would be desired. In real clinical situations, a more
complex diuretic titration may be required to maintain ideal body
fluid condition. However, some patients may not be able to follow
such complex instructions so instructions may be simplified at the
cost of a less effective titration.
[0010] In addition, if the sliding scale diuretic titration changes
frequently, some patients may not understand the change of sliding
scale diuretic titration and may end up taking the wrong dose of
medication. This may lead to serious complications. Taking too much
medication may lead to complications such as dehydration,
electrolyte imbalance, hypotension, and kidney failure.
Conventional sliding scale diuretic titration is also limited to
oral diuretics, which may not be as effective as, for example,
continuous infusion of diuretics.
[0011] As a result of these possible complications, sliding scale
diuretic titration, when attempted, is typically based on a
straightforward and simple protocol. More complex protocols
generally have not been attempted because there is not a reliable
way to carefully monitor and control the dispensing of diuretic or
to adjust the dose according to varying conditions. In addition,
there are not reliable safety measures to safeguard against the
possible inappropriate use of diuretics. Without such controls and
safety measures, more complex protocols can have a higher risk of
inappropriate use of diuretics and possible adverse effects such as
dehydration, electrolytes abnormalities, hypotension, and kidney
failure.
[0012] Thus, there is a need for better, and preferably automatic,
approaches to control body fluid condition using diuretics.
SUMMARY OF THE INVENTION
[0013] One aspect of the present invention overcomes the
limitations of the prior art by automatically infusing diuretic
into a human patient. In one approach, the rate of infusion of the
diuretic is adjusted based on various biological parameter(s) other
than body weight, although possibly in combination with body
weight. The biological parameter(s) can be transmitted wirelessly
to a portable diuretic infusion device attached to the patient, for
example.
[0014] In one aspect of the invention, a portable diuretic infusion
device includes a reservoir, a pump and a controller. The reservoir
can hold a diuretic or an antihypertensive drug to be infused into
the patient. The pump is connected to the reservoir and is also
connectable to the patient, for example using an infusion set. The
pump is operated to infuse diuretic or other drug from the
reservoir into the patient. The controller controls the pump based
on some biological parameter(s), thereby controlling the rate of
infusion of the diuretic or other drug.
[0015] In one embodiment, the controller adjusts the rate of
infusion based on a measured intrathoracic electrical impedance of
the patient. For example, the protocol may be designed to maintain
a target intrathoracic electrical impedance for the patient, so
that more diuretic is infused when the patient is over the target
and less diuretic is infused when the patient is under the target.
In another aspect, the patient's intrathoracic electrical impedance
can be measured by an implantable device and then wirelessly
transmitted to the diuretic infusion device. The controller on the
diuretic infusion device receives the intrathoracic electrical
impedance information and automatically adjusts the infusion
rate.
[0016] In another aspect of the invention, the diuretic infusion
device adjusts the diuretic infusion rate based on various
biological parameter(s). These biological parameters can include,
for example, vital signs, blood pressure, intracardiac pressure,
intravascular pressure, biomarker(s), physical sign(s), weight,
NYHA classification, and/or symptoms,
[0017] In still a further aspect of the invention, the diuretic
infusion system includes a biological parameter measurement
apparatus with a biological parameter measurement sensor for
measuring a biological parameter of a human patient and a wireless
transmitter for wirelessly transmitting measured biological
parameter information. The diuretic infusion system also includes a
portable diuretic infusion device with a reservoir for holding
diuretic, a pump connected to the reservoir and connectable to the
human patient, for infusing diuretic from the reservoir into the
human patient, a wireless receiver for wirelessly receiving the
biological parameter information transmitted by the biological
parameter measurement apparatus, and a controller coupled to the
wireless receiver, for controlling the pump and rate of infusion of
the diuretic based on the received biological parameter
information.
[0018] In further embodiments, the diuretic infusion system is
remote control operated. The system can include a biological
parameter measurement apparatus having a sensor for measuring a
biological parameter of a human patient and a wireless transmitter
for wirelessly transmitting biological parameter information based
on the measured biological parameter. The system can further
include a portable diuretic infusion device with a reservoir for
holding diuretic, a pump connected to the reservoir and connectable
to the patient, a controller for controlling the pump, and a
wireless receiver for wirelessly receiving commands. The system can
also include a remote control device with a wireless receiver for
wirelessly receiving the biological parameter information
transmitted, a wireless transmitter for wirelessly transmitting one
or more commands to the portable diuretic infusion device, and a
controller coupled to the receiver/transmitter for wirelessly
controlling the pump and rate of infusion based on weight
information. Other embodiments of the diuretic infusion system can
include fewer or more components within the biological parameter
measurement apparatus, the portable diuretic infusion device, and
the remote control device.
[0019] In yet another embodiment, the diuretic infusion system
includes a urine output measurement apparatus with a urinary
catheter, a urinary drainage apparatus, and a urine output sensor
for measuring urine output of a human patient. In some embodiments,
the urine output measurement apparatus also includes a wireless
transmitter for wirelessly transmitting urine output information
based on the measured urine output. The system can also include a
portable diuretic infusion device with a reservoir for holding
diuretic, a pump connected to the reservoir and connectable to the
patient for infusing diuretic from the reservoir into the patient,
and a controller that controls the pump, thereby controlling a rate
of infusion of the diuretic based on received urine output
information. Where the urine output measurement apparatus is
configured for wireless communication, the portable diuretic
infusion device can include a wireless receiver for wirelessly
receiving the urine output information transmitted from the urine
output measurement apparatus. In some embodiments, the infusion
system further includes a remote control device with a wireless
receiver for wirelessly receiving the urine output information
transmitted from the urine output measurement apparatus, and a
wireless transmitter for wirelessly transmitting one or more
command to the portable diuretic infusion device. The remote
control device can also include a controller coupled to the
wireless receiver and transmitter for wirelessly controlling the
pump and rate of infusion of the diuretic based on the received
urine output information
[0020] Different protocols can be implemented using these devices
and systems. For example, the infusion rate can include both basal
and bolus components. Diuretic infusion can be supplemented and/or
replaced by other delivery mechanisms, such as oral diuretics.
Fairly complex protocols can be implemented, since the protocol is
more automated and depends much less on the patient implementing
the protocol. For example, infusion rate can vary by time of day,
thus reducing urination at nighttime. Prospective infusion can also
be implemented, for example if heavy salt intake is expected. The
infusion rate can also be adjusted based on feedback other than
just weight.
[0021] These approaches allow the dose of diuretics to be
controlled much more carefully than by patient instructions alone,
resulting in many possible advantages. For example, early detection
and early treatment of various body fluid related diseases may be
possible. This can reduce hospitalizations and death from
congestive heart failure, pulmonary edema and fluid overload. In
addition, patients can now have continuous infusion of diuretics by
using a portable, ambulatory infusion pump. Continuous infusion of
diuretics may be more effective than bolus use of diuretics. These
approaches may also be more effective in maintaining target weight
and/or dry weight, compared with using oral diuretics. The
automated approach is also easier for patients and allows the
implementation of more complex protocols, while also reducing the
risk of over- or under-treatment. The automated devices can also
record diuretic use (and also body weight), thus providing a
reliable medical history. This information can be sent over the
internet to the healthcare providers or others, for analysis or
remote monitoring of patients.
[0022] Other aspects of the invention include methods corresponding
to the devices and systems described above, and protocols for use
with same.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] The invention has other advantages and features which will
be more readily apparent from the following detailed description of
the invention and the appended claims, when taken in conjunction
with the accompanying drawings, in which:
[0024] FIGS. 1 depicts a diuretic infusion system.
[0025] FIG. 2 depicts a more detailed view of a diuretic infusion
device.
[0026] FIG. 3 is a block diagram of a diuretic pump.
[0027] FIGS. 4 and 5 are a mechanical depiction of a diuretic
pump.
[0028] FIG. 6 is a mechanical depiction of a diuretic pump with two
reservoirs.
[0029] FIG. 7 shows data flow for computation of diuretic infusion
rate.
[0030] FIG. 8 illustrates infusion of diuretic into the body.
[0031] FIG. 9 is a mechanical depiction of another diuretic
pump.
[0032] FIGS. 10-11 further illustrate operation of further
embodiments for diuretic dispensing.
[0033] FIG. 12 illustrates further embodiments for a diuretic
infusion system.
[0034] FIG. 13 illustrates another diuretic infusion system.
[0035] FIGS. 14 and 15 show protocols for use with the diuretic
infusion system of FIG. 13.
[0036] FIG. 16 illustrates another diuretic infusion system
including an electric scale.
[0037] FIGS. 17-20 show protocols for use with the diuretic
infusion system of FIG. 16.
[0038] FIG. 21-22 illustrates another diuretic infusion system
including an implantable device.
[0039] FIG. 23 shows a protocol for use with the diuretic infusion
system of FIG. 21.
[0040] FIG. 24 illustrates another diuretic infusion system
including a remote control device.
[0041] FIG. 25 illustrates a more detailed view of the diuretic
infusion device and the remote control device.
[0042] FIG. 26 illustrates the operation of a closed loop drug
infusion system for a diuretic infusion pump system.
[0043] FIG. 27 illustrates wireless communication of a diuretic
infusion pump system with biological parameter measurement
apparatuses.
[0044] FIG. 28 a diuretic infusion device with a patch sensor
system.
[0045] FIG. 29 illustrate additional drug-infusion protocols
[0046] FIG. 30 illustrates a wirelessly-operated diuretic injecting
pen-type device.
[0047] FIG. 31 illustrates the components of the diuretic injecting
pen-type device.
[0048] FIG. 32 illustrates examples of the biological parameters
measured by devices or sensor communicatively coupled to the
diuretic injecting pen-type device.
[0049] FIG. 33 illustrates a data flow for computation of the
diuretics dose for the diuretic injecting pen-type device.
[0050] FIG. 34 illustrates another type of drug-dispensing pen-type
apparatus for dispensing pills.
[0051] FIG. 35 illustrates a disposable external diuretic infusion
pump.
[0052] FIG. 36 shows another embodiment of a diuretic infusion pump
with a feedback mechanism.
[0053] FIGS. 37 and 38 show various biological parameters and
factors that may be used with various embodiments, such as that of
FIG. 25.
[0054] FIG. 39 illustrates a diuretic infusion system including a
urine output measurement apparatus.
[0055] FIG. 40 illustrates the operation of the system of FIG.
39.
[0056] FIG. 41 illustrates a wirelessly operated diuretic infusion
system with urine output measurement apparatus.
[0057] FIG. 42 illustrates an example of a furosemide infusion
protocol based on urine output.
[0058] FIG. 43 illustrates an ambulatory diuretic infusion pump
with urine output measurement apparatus.
[0059] FIG. 44 illustrates another ambulatory diuretic infusion
pump.
[0060] The figures depict embodiments of the present invention for
purposes of illustration only. One skilled in the art will readily
recognize from the following discussion that alternative
embodiments of the structures and methods illustrated herein may be
employed without departing from the principles of the invention
described herein.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0061] FIG. 1 depicts a diuretic infusion system according to the
invention. Diuretic infusion device 101 is located on the patient's
body 102. Weight sensor 103 measures the patient's body weight. In
one embodiment, the weight sensor 103 is an electric scale. A user
inputs measured body weight into the diuretic infusion device 101.
The diuretic infusion device 101 delivers diuretic to the human
body 102. The dose of the diuretic is determined based on the
measured body weight.
[0062] Various diuretics may be used with the diuretics infusion
device. Examples include hydrochlorothiazide, chlorothiazide,
chlorthalidone, metolazone, furosemide, bumetanide, ethacrynic
acid, torsemide, spironolactone, indapamide and eplerenone.
Vasopressin receptor antagonist may also be used. Examples include
conivaptan, tolvaptan. Brain natriuretic peptide may also be used.
One example is nesiritide.
[0063] FIG. 2 is a close-up of the diuretic infusion device 101 of
FIG. 1. In this example, the diuretic infusion device 101 is a
diuretic pump 201 that is attached to the body 207. A preferred
location is around the body waist and abdomen. The size of the
diuretic infusion pump can vary. In one implementation, the
diuretic pump is 2.2.times.3.7.times.1 inches. This diuretic
infusion pump 201 includes a wireless communications chip,
processing module, batteries and processor (see FIG. 3 for further
detail). The diuretic infusion pump 201 may not include the
wireless communications chip in alternative embodiments.
[0064] An external keypad to allow the user to program an onboard
processor. The onboard processor controls the rate of diuretic
infusion. Various buttons 202, 203 are used for various functions,
such as programming the diuretics pump and adjusting the diuretic
infusion rate. Information such as rate of diuretic infusion, name
of diuretics in use, weight information, and optimal or target
weight, can be displayed on the screen 204. This screen also shows
signals that indicate malfunction of the device and other signals
such as time to change a diuretics cartridge or time to change a
battery.
[0065] This diuretic infusion pump 201 includes a disposable
reservoir or a disposable cartridge for the diuretic. The prefilled
cartridge containing diuretics is replaced when empty. In
alternative embodiments, the reservoir and/or cartridge may not be
disposable. Instead, the reservoir may be refilled when empty.
[0066] A disposable infusion set for the diuretic infusion pump may
include a cannula 209, an adhesive pad 205, a needle 208 and tubing
system 206 (that delivers the diuretic reservoir to a user). The
user inserts the needle 208 together with the cannula 209 under the
skin. The needle 208 may be removed, leaving the cannula 209 under
the skin. Preferably, the tip of the cannula 209 is located at the
subcutaneous tissue. Alternatively, the tip of cannula 209 may be
located in the abdominal cavity, intramuscular space, intravascular
space or peritoneal cavity. The cannula 209 may be made with
biocompatible materials such as polyethylene.
[0067] FIG. 3 is a block diagram of a diuretic pump. Processor 301
(the controller) is contained in the interior of the housing 316 of
the diuretic infusion pump. The housing 316 may be made of plastic
or steel, for example. Processor 301 runs software programs and
controls components of the diuretics infusion pump. The Freescale
Dragonball microprocessor is one example of a processor that may be
used. The Motorola 6805 is another example. The Freescale
MC9S08RX32A is another example. The MC9S08RX32A includes an RF
integrated circuit and microcontrollers (MCU). Other processors
that are used in insulin pumps may also be used.
[0068] The processor 301 is in electrical communication with an
electric motor and pump 313. The processor controls the electric
motor 313 according to its program. The processor also controls a
screen 304, an audible alarm 307, vibratory alarm 308 and telemetry
system. Weight information that is transmitted from the weight
measurement apparatus is received by the telemetry system of the
diuretic infusion pump. It then enters the processor 301.
Alternately, weight information may be input into the diuretic
infusion pump manually by a user, for example from a keypad or a
remote controller.
[0069] In this example, flash memory 314 and SRAM 315 are used for
memory storage. This memory may store information such as pump
settings, a historical log of weight, malfunctions of the pump,
infusion rate, a historical log of infusion rate, medication, etc.
In one design, the RAM has 100 kilobytes, ROM has 4 megabytes and
flash memory has 4 megabytes memory. Alternate memory media include
RAM, ROM, EPROM, DRAM, hard-drives and other types of flash
memory.
[0070] The user may program the processor 301 using a keypad (or
other user interface) on the diuretic infusion pump. In alternative
embodiments, a user may use a remote controller or a computer
station to program the processor 301.
[0071] Information and commands from other computers, portables
devices such as PDAs (personal digital assistant), handheld
computers, portable phones, remote controllers and the internet may
be received through receiver 303. Examples of wireless technologies
include radio frequency (RF), infrared (IR) and optical. Specific
technologies include Bluetooth, DECT, ZigBee, NFC, GSM, UWB, UMTS,
DAB, CDMA, WiFi and WIMAX. Wired communications ports can include
Universal Serial Bus (USB) ports and/or RS-232 ports, as well as
other technologies.
[0072] The diuretic infusion pump displays on its screen whether
new weight information, command, or alerts are received. The
diuretic infusion pump, weight measurement apparatus, corresponding
computer systems and/or remote controller may be assigned a unique
identifier and/or password to provide privacy for its users.
[0073] In FIG. 3, a keypad 309 is located on the housing 316. A
touch screen input device may also be used. The keypad 309 shown in
FIG. 2 includes buttons 203, 202 to provide input to the processor
301.
[0074] Various other inputs, such as various types of sensors, may
also be included in the diuretic infusion pump (or communicate to
the diuretic pump from other parts of the system). For example,
motion detection sensor 312 may be used to detect the motion of a
gear in the drive mechanism for the pump. Cartridge sensor or
reservoir sensor 311 may be used to detect the amount of diuretic
left within a cartridge or reservoir, and to notify a user when a
new cartridge is required or a reservoir requires refilling.
[0075] In one embodiment, LCD is used as a screen. Feedback from
the weight measurement apparatus, a computer, a remote control
device as well as diuretic infusion pump status and programming
changes may be displayed on a LCD screen. Time, name of drug, dose
of drug used during a particular period of time, reservoir or
cartridge usage and history may also be displayed.
[0076] A speaker can be used to send audio feedback. A user may
choose to use a vibratory alarm instead of audible alarm. For
example, if measured body weight is too low or too high, an audible
or vibratory alarm may warn a user. If measured body weight is
lower than a set value, a certain instruction such as "Drink more
water and eat more because you may be dehydrated" may be shown on
the screen or played through the speaker. When measured body weight
is higher than a set value, certain instructions may be expressed,
such as "Calibrate your weight measurement scale" or "Call your
doctor if you feel shortness of breath." Alarms may also be
activated for pump malfunction, low battery, dead battery,
occlusion of infusion set, near-empty cartridge (or reservoir),
pump delivery error, if bolus is changed, if mode is changed, if
pump is not primed, if infusion exceeds maximum limits, etc.
[0077] The diuretic infusion pump preferably uses a AAA alkaline
battery. More than one AAA alkaline batteries may be used.
Alternatively, different types of batteries may be used such as
nickel cadmium battery, nickel metal hydride battery, lithium ion
battery, carbon battery, lithium battery and 3.6V lithium battery.
The battery may be included inside the housing 316 of the diuretic
infusion pump.
[0078] Not all embodiments require all of the components described
above.
[0079] FIG. 4-5 are mechanical depictions of a diuretic pump. The
diuretic infusion pump contains a processor 401. The processor is
electrically connected or otherwise communicatively coupled to an
electric motor 402, for example a DC motor with gear-reducer. The
processor 401 controls the electric motor 402 according to its
programming. The electric motor 402 is connected to a peristaltic
pump 404. The peristaltic pump 404 has a rotor inside. A flexible
tube inside the peristaltic pump 404 is connected with a tube 405
and 408. The flexible tube is in contact with the rollers. When the
rotor turns, one or more rollers squeeze and release the flexible
tube to deliver drug from a reservoir 403 to a user via the
infusion tube 408. In order to detect if the diuretics solution is
depleted and needs to be replaced or refilled, a sensor 409 can be
used. FIG. 5 is a simplified mechanical depiction of a syringe pump
system. The pump housing 515 contains a syringe 516. The syringe
516 contains diuretics. The processor 510 is electrically connected
or otherwise communicatively coupled to an electric motor 511. The
processor 510 controls the electric motor 511 according to its
programming. The motor 511 rotates a motor gear which moves a screw
513 axially. A screw 513 is configured to move axially to push a
plunger 514 inside a syringe and push diuretics out of a syringe
516 or a reservoir through an infusion tube 518 and a cannula 519.
The plunger mechanism transfers the diuretics solution from a
diuretics cartridge or reservoir through an outlet of the housing
to the patient via tubing system 405, 408 and the infusion set.
Technologies used in insulin pumps may be used also for diuretic
pumps.
[0080] In alternative embodiments, more than one type of drug may
be used in the diuretic infusion pump. A processor may be coupled
with more than one program, software, protocols and/or parameters
that are tailored according to the specific drug that is used. The
diuretic infusion pump may automatically recognize the inserted
drug. Drug reservoir or cartridge may have a unique identification
code. One example of a drug name recognition method is to decode
the bar code of the drug name, which is attached on the reservoir
or cartridge. Alternatively, the name of the inserted drug may be
manually put into the diuretic infusion pump using the keypad which
can select alphabets on the screen.
[0081] Examples of medications that may be contained in the
reservoir 807 or cartridge include hydrochlorothiazide,
chlorothiazide, chlorthalidone, metolazone, furosemide, bumetanide,
ethacrynic acid, torsemide, spironolactone, eplerenone, vasopressin
receptor antagonists, conivaptan, tolvaptan, brain natriuretic
peptide, and nesiritide.
[0082] FIG. 6 is a mechanical depiction of a diuretic pump with two
reservoirs: in this case a diuretics reservoir 601 and an insulin
reservoir 602. Patients with diabetes may also have congestive
heart failure. This device delivers both diuretics and insulin
using one ambulatory infusion pump. In embodiments that use two
reservoirs, each medication is delivered via tubes 603, 604 inside
an ambulatory infusion pump and leaves the housing of the pump via
a tube 609 outside the ambulatory infusion pump. There may be two
separate channels within the tube 609 through which each medication
is delivered separately. Each medication is delivered to a user
through different holes 611, 612. In alternative embodiments, a
syringe pump system can be used instead of a peristaltic pump 606.
Two syringes can have separate electric motors that control the
movement of the plunger of the respective syringes and release of
each medication.
[0083] Some medications may not be compatible each other so these
medications may need to be delivered through separate channels.
More than two medications, channels and holes may be used in
alternative embodiments. A processor 610 controls an electric motor
605 and a pump 606 according to its program. More than two electric
motors and pumps may be used in alternative embodiments. A separate
electric motor and pump may be used to deliver different
medications in alternative embodiments.
[0084] FIG. 7 shows possible data flow for computation of the
diuretic infusion rate. In preferred embodiments, the processor of
the diuretic infusion pump uses weight to compute the diuretics
infusion rate. In alternative embodiments, the processor may use
various other factors to compute diuretic infusion rate. Examples
include physical signs, vital signs, bio markers, symptoms,
intracardiac pressure, intravascular pressure, intrathoracic
electrical impedance and New York Heart Association (NYHA)
classification, as shown in FIG. 7. For example, if BNP (B-type
natriuretic peptide) is elevated, this may indicate increased body
fluid volume and congestive heart failure. If BNP is above 100
pg/ml, the diuretic infusion pump may increase (or adjust) the
infusion rate until the levels returns to normal.
[0085] ANP (Atrial natriuretic peptide), CNP (C-type natriuretic
peptides), NT-pro BNP, ventricular natriuretic peptides and other
bio markers that indicate volume overload and heart failure may
also be used to compute the diuretic infusion rate.
[0086] Physical signs of volume overload, such as ankle swelling,
leg swelling, arm swelling, and abdominal distension can also be
used. For example, a user may use a scale of one to four in body
swelling as one being no swelling, four being severe swelling,
three being moderate swelling, two being mild swelling. The
diuretic infusion pump might adjust the infusion rate to return
body swelling to the zero score condition of no swelling. The
diuretic infusion pump may also adjust the infusion rate based on
blood pressure.
[0087] The diuretic infusion pump may also adjust the infusion rate
by using symptom scores such as a shortness of breath scale (one to
four, one-no difficulty breathing, two-mild difficulty,
three-moderate difficulty, four-severe difficulty) or a walking
scale (one- can walk without limitations, two-can walk less than
one block, three-can barely walk even inside home).
[0088] The diuretic infusion pump may use the NYHA (New York Heart
Association) classification to compute the diuretics infusion rate.
The NYHA classification is widely used to assess the stage of heart
failure. The diuretic infusion pump may adjust diuretics infusion
rate to improve patient condition from class II, III or IV to class
I.
[0089] Combinations of variables may be used for the computation of
diuretic infusion rate and/or dose. These variable(s) may be used
for the computation of the dose and/or infusion of other drugs.
Some examples of these drugs include, but not limited to,
anti-hypertensive drug, inotropic agents, and anti-arrhythmic
drugs.
[0090] Adjusting the diuretic dose according to intracardiac
pressure or central vein pressure is another possibility.
[0091] FIG. 8 illustrates infusion of diuretic into the body. In
FIG. 2, diuretic medication is infused into subcutaneous tissue. In
alternative embodiments shown in FIG. 8, diuretic medication may be
infused into a peritoneal cavity, an intravascular space (e.g.,
into a vein) or intramuscularly. The diuretic infusion pump 807
attaches to a tubing system 806, an adhesive 805 and a needle
803.
[0092] A plastic tube 801 (a catheter) is attached to a silicone
bubble 804 (septum). Tip 808 of the plastic tube may be located
into a peritoneal space or a vein (or an artery). A needle 803 is
inserted into the silicone bubble. Medication is delivered from the
infusion pump 807 through a tubing system 808, a needle 803 and a
plastic tube 801 into a target space of a user. Examples of a
target space include a peritoneal space, a vein, an artery and a
muscle. A port 802 and silicone bubble 804 may be located in
subcutaneous tissue or may be located outside the skin.
[0093] FIG. 9 is a mechanical depiction of yet another diuretic
pump. More than two drugs may be infused in alternative
embodiments. Two drugs are contained in the separate drug reservoir
or cartridge. One example of two drugs that may be used includes
diuretics and insulin. Another example of two drugs that may be
infused includes loop diuretics and thiazide diuretics. Other
examples of two drugs that may be used includes "loop diuretics and
vasopressin receptor antagonist", "thiazide diuretics and
vasopressin receptor antagonist", "loop diuretics and potassium
sparing diuretics", "thiazide diuretics and potassium sparing
diuretics" and "loop diuretics and carbonic anhydrase inhibitor."
Using the combination of diuretics with a different site of action
may be more effective than using only one type of diuretic. Loop
diuretics act on the ascending loop of Henle in the kidney.
Thiazide diuretics act on distal convoluted tubule in the kidney.
Examples of vasopressin receptor antagonists include conivaptan and
tolvaptan.
[0094] FIG. 6 shows an infusion pump with two drug reservoirs 601,
602 that share one pump 606. FIG. 9 shows two peristaltic pumps
903, 904 connecting with two different reservoirs 901, 902. A
processor 905 is electrically connected with electric motors 911,
912. The processor 905 controls these electric motors 911, 912 and
pumps 903, 904 to deliver medication from each medication reservoir
901, 902. The pump 903 is connected with a reservoir 901 and
delivers a medication from a reservoir 901 through a tubing system
906, 908 to a user. The pump 904 is connected with the reservoir
902 and delivers medication from the reservoir 902 through a tubing
system 907, 909 to a user.
[0095] In this example, the tube 908 merges with tube 909. However,
there are different channels within the tube to deliver each
medication through different channels to prevent mixture of
non-compatible medications. These two medications are delivered
through separate openings 910, 913. Two medications may be
delivered according to two separate programs, protocols,
parameters.
[0096] In alternative embodiments, a diuretic inhaler may be used.
Examples include a furosemide inhaler, a bumetanide inhaler, and so
forth. If measured body weight is above a previously set target
weight, the display on the weight measurement apparatus, the
diuretic inhaler or a separate device may show instructions on the
dose of drug to be inhaled. For example, if measured body weight is
one kilogram above the target weight, a user may be instructed to
have one extra-inhalation of furosemide. Other diuretic inhalers,
including (but not limited to) furosemide, bumetanide, and
torsemide, may be used in alternative embodiments.
[0097] FIGS. 10 further illustrate operation of other embodiments.
In FIG. 10, the diuretic infusion device has various other
functions that may improve the health of patients. For example, if
intravascular pressure increases due to increased body fluid, it
helps to remind patients to control the amount of salt (sodium)
that they take daily. The display 1002 shows instructions to avoid
food high in sodium chloride. This device may also provide a list
of foods high in sodium content, low in sodium content, high in
potassium, magnesium, calcium, and/or low in potassium, magnesium,
calcium. Diet information may be provided for educational purposes.
In alternative embodiments, the device may have a scanner to scan
food to notify users whether scanned foods are appropriate for
users to take or not. The data (e.g. images) obtained from food
scanning may be compared with data saved in the database within the
diuretic infusion device to retrieve information on the scanned
food. If the scanned food is high in sodium content, instruction to
avoid this food may be shown on the display of the diuretic
infusion pump. The food scanning can be performed by a separate
device such as PDA, a handheld computer, a remote control device, a
portable phone, an iPHONE.TM., an iPOD.TM., and so forth.
[0098] The diuretic infusion device may also be connected with a
blood pressure cuff, either wirelessly or in a wired manner. Blood
pressure information measured by the blood pressure cuff is
transmitted to the diuretic infusion pump. Certain instructions may
be provided on the display 1002. See FIG. 16. A database of
references on health topics, drug information, emergency
instruction, BLS (basic life support) may be saved in the memory
within diuretic infusion device or diuretic dose instruction device
and can be viewed on the display of the device. Examples of
instructions include reminding a user to take antihypertensive
medications as scheduled, instructing a user to adjust the dose of
antihypertensive medications if blood pressure is low or high. If a
user develops chest pain, shortness of breath or other urgent
medical conditions, the user may be instructed to call his doctor
or go to the nearby emergency room or call 911. A user may press an
emergency button 1003 to notify family, help agent, 911 or hospital
for help during emergent situations. These various functions may be
programmed by a healthcare provider.
[0099] Instructions to take potassium supplement, magnesium
supplement and other electrolyte supplement may be displayed on the
screen. These electrolytes may be lost by the kidneys as diuretics
dose increases. In FIG. 10, a user is instructed to take potassium
chloride (KCL) 20 meq. See also FIG. 35.
[0100] FIGS. 12 and 14 show additional protocols for diuretic
dispensing.
[0101] FIG. 11 illustrates another example. Diuretic infusion pump
1101 has a screen 1 102. A user uses a keypad to edit target
intravascular pressure information. The target intravascular
pressure is displayed on the screen. A cursor is located on the
number of the intravascular pressure. In this FIG. 11, it is
located on the digit 12 1103. A user can choose different number
using scrolls 1104, 1105. S button 1106 is pressed to select a
number. The current intravascular pressure can be manually put into
the diuretic infusion pump in a similar manner.
[0102] In FIG. 12, a furosemide infusion protocol is shown on the
screen 1201 of the diuretic infusion pump 1202. The underlined
numbers can be changed using scroll buttons 1203, 1204. If scroll
button 1203 is pressed, the number increases. If scroll button 1204
is pressed, the number decreases. The cursor is located on
underlined thick number 1207, which is a 8. If scroll button 1203
is pressed once, the 8 changes to 9. If scroll button 1204 is
pressed once, the 8 changes to 7. If button S 1205 is pressed, the
number is selected. If button S is pressed when number 1207 is 8,
the 8 is selected and cursor moves on to next underlined number
1208. If all numbers are selected, button M is pressed to move on
to another menu.
[0103] FIG. 13 illustrates another diuretic infusion system. An
implant 1304 is located under the skin of human body 1301. The tip
of the wire of the implant is located inside a cardiac chamber 1302
to monitor intracardiac pressure. The tip of the wire of the
implant may be located in a central vein, pulmonary artery or other
vessel in alternative embodiments. A pressure measuring sensor is
attached to the tip or other portion of the wire of the implant.
The implant may be coupled with a processor, wireless communication
module, a controller and a software program. The diuretic infusion
pump 1303 communicates wirelessly with the implant 1304 that
monitors intracardiac pressure and/or central vein pressure. If the
pressure is elevated inside the cardiac chamber or central vein,
this may indicate a sign of volume overload. The diuretic infusion
pump may adjust its infusion rate according to the pressure
measured by this implant.
[0104] In one approach, a user inputs a target pressure into the
diuretic infusion pump. The diuretic infusion pump adjusts its
infusion rate to maintain the target pressure. One example of a
suitable implant is the Chronicle heart monitor made by
MEDTRONIC.TM.. In alternative embodiments, a pacemaker, an
automatic implantable cardioverter defibrillator (AICD), or a
cardiac resynchronization therapy (CRT) device may be coupled with
the pressure measuring sensor, wireless communication module,
processor and software program to transmit pressure signals to the
diuretic infusion pump.
[0105] FIG. 14 illustrates a diuretics protocol that may be used
with the diuretic infusion device of FIG. 13. A pressure monitoring
sensor is located in the central vein, for example the superior
vena cava. The implant shown in FIG. 13 transmits a pressure signal
wirelessly to the diuretic infusion pump. The diuretic infusion
pump adjusts the diuretic infusion rate according to the pressure
measured by the pressure monitoring sensor, as shown in FIG. 14.
The diuretic infusion pump adjusts the infusion rate to maintain a
target pressure within the cardiac chamber, central vein or other
vessel. Various other protocols may be used to adjust diuretic
infusion according to the pressure. The pressure signal can also be
used to trigger safety measures. For example, the diuretic infusion
device can be programmed to automatically stop infusion and notify
a user if the blood pressure falls below a previously set value.
This is to avoid hypotension that may occur with use of high dose
diuretics. For example, a diuretic infusion pump may be programmed
to automatically stop infusion and notify the user (and/or doctor),
if the systolic blood pressure is below 90 mmHg. Various
non-invasive biological parameter measurement device such as a
patch sensor system, a non-invasive central aortic pressure
measurement device, a non-invasive intravascular blood pressure
measurement device may be coupled with a diuretic infusion pump
wirelessly or via other means such as manual data input and wired
communication.
[0106] FIG. 15 shows another example of furosemide protocol. A
blood pressure monitoring sensor located in a central vein can
transmit a measured blood pressure signal to the diuretic infusion
pump. The diuretic infusion pump displays the instructions
regarding the dosage of oral furosemide.
[0107] FIG. 16 depicts another embodiment of the present invention.
A blood pressure cuff 1604 is attached to an arm of a human body
1602. The blood pressure cuff 1604 can be connected to a blood
pressure measuring device 1605. The blood pressure measuring device
1605 can be coupled to a processor, wireless communication module,
a controller and a software program, though it may not be coupled
to all of these in some embodiments. The diuretic infusion pump
1601 can communicate wirelessly or via other means with the blood
pressure measuring device 1605. In alternative embodiments, the
blood pressure measuring device 1605 can communicate wirelessly or
via other means with an electric scale 1603. In alternative
embodiments, a user manually inputs measured blood pressure into a
diuretic infusion device or a remote control device.
[0108] FIG. 17 illustrates another example of a furosemide infusion
protocol. As shown in FIG. 16, the diuretic infusion pump receives
the measured blood pressure wirelessly from the blood pressure
measurement device. If the measured blood pressure is below a set
blood pressure, the diuretic infusion pump can be programmed to
stop furosemide infusion automatically to prevent hypotension,
dehydration.
[0109] FIG. 18 illustrates an example of a furosemide and
enalaprilat infusion protocol. As shown in other figures, the
diuretic infusion pump can contain more than one drug reservoir. In
this example, the diuretic infusion pump has one reservoir
containing furosemide and another reservoir containing enalaprilat.
Enalaprilat is an angiotensin converting enzyme (ACE) inhibitor
which is an antihypertensive drug. The protocol in FIG. 45 shows
the diuretic infusion pump infusing enalaprilat as well as
furosemide according to measured blood pressure to maintain target
blood pressure.
[0110] FIG. 19 illustrates another example of a furosemide and
enalaprilat infusion protocol. The diuretic infusion pump adjusts
the infusion rate and a dose of enalaprilat and furosemide
according to the measured blood pressure to maintain target blood
pressure.
[0111] FIG. 20 illustrates an example of furosemide and metoprolol
infusion protocol. Metoprolol is a beta blocker which lowers blood
pressure and heart rate. The diuretic infusion pump may contain one
reservoir containing furosemide and one reservoir containing
metoprolol. The diuretic infusion pump adjusts the infusion rate
and dose of metoprolol and furosemide according to the measured
blood pressure to maintain target blood pressure. The diuretic
infusion pump may adjust the infusion rate and dose of metoprolol
to maintain target heart rate. A patient with heart disease may
develop arrhythmia, such as supraventricular tachycardia (rapid
heart rate), atrial fibrillation, or ventricular tachycardia. The
diuretic infusion pump can infuse metoprolol to lower heart rate.
In alternative embodiments, the diuretic infusion pump can
communicate wirelessly with an implantable cardioverter
defibrillator (ICD), a pacemaker. If an ICD or a pacemaker detects
arrhythmia, the ICD or pacemaker can send this arrhythmia
information wirelessly or via other means to the diuretic infusion
pump. The diuretic infusion pump may infuse an anti-arrhythmic drug
to treat the arrhythmia. Examples of anti-arrhythmic drugs include,
but are not limited to, amiodarone, metoprolol, sotalol, esmolol,
lidocaine, disopyramide, propafenone, dofetilide, flecainide,
procainamide and atropine. The diuretic infusion pump may contain
and infuse only anti-arrhythmic drug communicating with an ICD or a
pacemaker in alternative embodiments.
[0112] In another embodiment, a user can use one reservoir that
contains diuretics and a second reservoir that contains an
inotropic drug that increases blood pressure. Examples of inotropic
drugs include (but are not limited to) dopamine, dobutamine,
phosphodiesterase inhibitor, amrinone, milrinone, enoximone,
pimobendan, levosimendan, calcium sensitizing agent, venarinone,
and ibopamine. In alternative embodiments, the diuretic infusion
pump contains a combination of antihypertensive drugs, inotropic
agents, diuretics, and it adjusts the infusion rate according to
blood pressure measured by non-invasive blood pressure measurement
device and/or measured body weight.
[0113] FIG. 21 depicts another embodiment. An implantable device
2104 has a pair of electrodes on the surface. The implantable
device 2104 is connected to a cardiac ring electrode or coil
electrode positioned in the heart 2105 in the human body 2101 via a
wire 2102. Intrathoracic impedance between the implantable device
case and the right ventricular lead can be measured multiple times
a day. If the intrathoracic impedance decreases, this may suggest
fluid is accumulating in the lungs due to worsening heart failure.
The implantable device 2104 can be a pacemaker, an implantable
cardioverter defibrillator, or a cardiac resynchronization therapy
device. One example of a suitable implant is OptiVol fluid status
monitoring device from Medtronic. The diuretic infusion pump 2103
can communicate wirelessly with the implantable device 2104. The
diuretic infusion pump 2103 can adjust the infusion rate of
diuretics according to the measured impedance to maintain the
target impedance. FIG. 49 illustrates an example of a furosemide
infusion protocol according to measured intrathoracic impedance.
The diuretic infusion pump may adjust the infusion rate of
diuretics according to the average of impedance measurements taken
over a predetermined period of time to maintain target measured
average impedance.
[0114] FIG. 22 depicts another embodiment. The diuretic infusion
pump 2203 receives weight information wirelessly or manually from a
weight measurement device 2201 and communicates wirelessly with the
implantable device 2204 which was shown in FIG. 21.
[0115] FIG. 23 illustrates an example of a furosemide infusion
protocol according to measured intrathoracic impedance. The
diuretic infusion pump may adjust the infusion rate of diuretics
according to the average of impedance measurements taken over a
predetermined period of time to maintain target measured average
impedance.
[0116] FIG. 24 illustrates another embodiment. A diuretic infusion
device 2401 is attached to a human body 2402. This portable
diuretic infusion device 2401 delivers diuretics from a reservoir
to the human body 2402. The diuretic infusion device 2401 may be
smaller in size compared to other embodiments shown in other
figures. This diuretic infusion device 2401 can be disposable. The
diuretic infusion device 2401 contains a reservoir, a programmable
processor, an exit port, a cannula and a motor, though some
embodiments may contain fewer components or additional components.
The diuretic infusion device 2401 can communicate wirelessly or via
other means with a remote control device 2404. The remote control
device 2404 can communicate wirelessly with an intrathoracic
impedance measurement device 2405 and a diuretic infusion device
2401 in one embodiment. The remote control device 2404 may
communicate wirelessly with only the diuretic infusion device 2401,
and not with the intrathoracic impedance measurement device 2405 in
alternative embodiments.
[0117] FIG. 25 further illustrates the diuretic infusion device
5101. The diuretic infusion device 2501 has a needle 2503 and
cannula 2502. The diuretic infusion device 2501 is connected to a
human body 2511 subcutaneously via a cannula 2502. The diuretic
infusion device 2501 is disposable in some embodiments, but the
reservoir of the diuretic infusion device can alternatively be
refilled via a hole 2505. The remote control device 2504 programs
and controls the diuretic infusion device 2501. The remote control
device 2504 contains a programmable processor, a controller, a
wireless transmitter/receiver, a keypad with order entry buttons
2507, 2508, 2509, 2510 and a display screen 2506, though some
embodiments may contain fewer components or additional components.
Measured biological parameters shown in other figures can be
transmitted wirelessly from a biological parameter measurement
device to the remote control device 2404, 2504 in this embodiment.
In alternative embodiments, a user manually inputs measured
biological parameters into the remote control device 2504. A
controller of the remote control device 2504 may be coupled to a
processor and a wireless receiver/transmitter. When biological
parameter information enters the processor of the remote control
device 5104, the processor can compute the dosage of diuretic based
on the biological parameter(s). The remote control device 2504
wirelessly transmits commands to the diuretic infusion device 2501.
The remote control device 2504 can control the infusion rate of the
diuretic infusion device 2501 wirelessly or by other means (e.g.,
wired). A user can choose and program particular diuretic infusion
protocol(s) using button(s) 2507, 2508, 2509, 2510 on the keypad of
the remote control device 2504. Various drug infusion protocols and
methods shown in other figures (see FIGS. 14-15, 17-20, 23, 55 and
other figures) may be embedded in the processor of the remote
control device 2504. The processor within the remote control device
2504 may be able to compute the dosage of a diuretic based on the
amount of salt, sodium and/or water of food. A user may infuse a
diuretic before or when the user eats food that contains salt
and/or water to excrete extra salt and water to maintain optimal
body fluid condition. In other embodiments, the processor within
the remote control device 2504 computes the dosage of diuretic
based on various biological parameters using protocols shown in
other figures. For example, FIGS. 36 and 37 show various biological
parameters and factors that may be used in these embodiments. The
biological parameter measurement sensors can be coupled with an
implantable device(s) like a pacemaker, an implantable cardioverter
defibrillator, a cardiac resynchronization therapy, etc. The remote
control device 2504 can communicate wirelessly with the biological
parameter measurement sensor(s). An intracardiac/intravascular
pressure monitoring sensor, an intrathoracic impedance monitor
sensor, or a patch sensor can communicate wirelessly with the
remote control device 2504 in alternative embodiments.
[0118] FIG. 26 illustrates another embodiment of the present
invention. In this embodiment, the diuretic infusion pump system
can be a closed loop drug infusion system. The closed loop drug
infusion system includes a biological parameter measurement sensor
and/or a biological parameter measurement device, a controller,
drug infusion pump, a drug delivery system, wireless communication
module, though not all of these may be included in alternative
embodiments or additional modules or devices may be included. In
the closed loop drug infusion system, measured biological parameter
signal enters the controller of the diuretic infusion system
wirelessly or via other means. The controller of the diuretic
infusion pump automatically adjusts and controls the drug infusion
according to the algorithms programmed in the diuretic infusion
pump in the closed loop drug infusion system. The controller of the
diuretic infusion pump adjusts the drug infusion to achieve or
maintain a target biological parameter which is programmed into the
diuretic infusion pump.
[0119] As shown in FIG. 27, many different biological parameter
measurement sensors and/or biological parameter measurement devices
can be used for the present invention. Examples of these biological
parameter measurement sensors/devices include, but are not limited
to, a patch sensor system, an intracardiac pressure sensor system,
an intravascular pressure sensor system, an intrathoracic impedance
monitor sensor system, a non-invasive blood pressure measurement
sensor system, a weight measurement sensor and/or device, a blood
pressure measurement cuff and device, a heart rate measurement
sensor system, an electrocardiogram monitoring sensor and/or
device, an arrhythmia monitoring sensor system and other vital sign
measurement devices. These biologic sensors can be coupled with
other implantable medical devices, such as a pacemaker, an ICD, or
a cardiac resynchronization therapy. The biological parameter
measurement sensor/device and the diuretic infusion pump can
preferably communicate wirelessly. The sensor/device and the
diuretic infusion pump may communicate via other means in
alternative embodiments. Other means may include, but are not
limited to, wired communication, manual data input and other
methods described in the present invention. More than one
biological parameter sensor and/or device may be used in
combination with a diuretic infusion pump. For example, a weight
measurement device and intravascular blood pressure measurement
sensor system may be used in combination with a diuretic infusion
pump. A weight measurement device and a patch sensor may be used in
combination with a diuretic infusion pump. These different sensors
and devices may communicate wirelessly or via other means.
Different types of patch sensors may be included in the closed
and/or open loop drug infusion system. The patch sensor is further
described in FIG. 28. The drug infusion system may adjust the
infusion of drug(s) according to an average (e.g., a mean or
median) value of biological parameters in alternative embodiments.
For example, the drug infusion system can adjust the infusion of
diuretics according to the average of the measured weight over
three days. If the daily measured body weight is 70 kg, 72 kg, 71
kg over the past three days, the diuretic infusion pump can be
programmed to adjust the rate of diuretic infusion according to 71
kg which is median value of three measured weights. The drug
infusion system can adjust the infusion of diuretics according to
the average value of measured intrathoracic electrical impedance
over a period of time. In some embodiments, the diuretic infusion
pump is programmed to adjust the rate of diuretic infusion
according to an average value of biomarkers, blood pressure,
intracardiac pressure or other biological parameters mentioned
previously over a certain period of time.
[0120] In alternative embodiments, the diuretic infusion pump
system is an open loop drug infusion system. The diuretic infusion
pump can receive measured weight or other biological parameters
from sensor(s) wirelessly or manually, however the diuretic
infusion pump may or may not automatically adjust the rate of
infusion in an open loop system. A user, a doctor, a nurse and/or
other people that are involved in the use of the diuretic infusion
pump system may need to approve or choose particular protocol(s)
and methods. These people can also control the controller of the
diuretic infusion pump. Healthcare provider(s) can transmit a new
order or new drug infusion protocols to the diuretic infusion pump
system via the Internet, a phone, or other methods. In an open loop
drug infusion system, wireless communication among the devices may
or may not be used.
[0121] In some embodiments, a user chooses an open loop system, a
closed loop system, or mixed loop system (e.g., a closed loop
system when a certain conditions are met and open loop system when
a certain conditions are not met). The diuretic infusion pump
system can be programmed to be a closed loop system when measured
blood pressure is within a certain parameter, when a user does not
have symptoms, such as chest pain, and/or when the dosage of an
infused drug is within a certain range. The diuretic infusion pump
can be programmed to be an open loop system when these conditions
are not met in a mixed loop system.
[0122] FIG. 28 illustrates a patch sensor system 2802 and a drug
infusion pump 2803. The patch sensor system 2802 is attached to a
human body 2801. The patch sensor system can contain more than one
sensor 2804, 2805 and/or electrodes 2804, 2805. The patch sensor
system can be coupled to a processor, wireless communication
module, a controller and software program, though it may not be
coupled to all of these in alternative embodiments or may be
coupled to additional devices. In some embodiments, the patch
sensor system 2802 measures blood pressure, heart rate,
intrathoracic electrical impedance, body fluid status, heart
rhythm, biomarkers, and detects heart arrhythmia. This patch sensor
2802 is preferably attached to the chest, but may be attached to
back, head or other parts of the body in alternative embodiments.
The patch sensor 2802 can include an electrode generating an
electrical waveform and/or an optical system generating an optical
waveform to measure various biological parameters, such as blood
pressure, pulse, oxygen saturation, heart rhythm. Intrathoracic
electrical impedance can be measured by the patch sensor system
2802 using multiple electrodes and/or multiple sensors.
Intrathoracic impedance between multiple sensors and electrodes can
be measured multiple times a day in one embodiment. The patch
sensor system 2802 communicates wirelessly with the diuretic
infusion pump 2803 in a closed loop drug infusion system or an open
loop drug infusion system. The diuretic infusion pump 2803 adjusts
the infusion of diuretics and/or other drugs according to
biological parameter(s) measured by the patch sensor system 2802 to
maintain the target biological parameter. The diuretic infusion
pump can adjust the infusion of diuretics and/or other drug(s) to
maintain, for example, target blood pressure, intrathoracic
impedance, heart rate, body fluid condition surrogate marker, etc.,
using drug infusion protocols shown in other figures. More than one
patch sensor system 2802 can be used and attached to different
parts of the body. One example of a suitable external patch sensor
monitoring system is MUSE.TM. clinical system from CORVENTIS.TM.,
INC.
[0123] FIG. 29 illustrates another example of a drug infusion
protocol. In one example, the measured intracardiac pressure of a
user is 17 mmHg and the target intracardiac pressure is set at 12
mmHg. There is 5 mmHg difference between the target cardiac
pressure and measured cardiac pressure, and the measured cardiac
pressure is above the target cardiac pressure. Following the
protocol seen in FIG. 29, the basal rate of furosemide infusion
increases by 0.3 mg multiplied by 5 and 0.3 mg multiplied by 5 is
equal to 1.5 mg. The basal rate of furosemide infusion increases by
1.5 mg per hour for 8 hours following the protocol. If the
previously set basal rate of furosemide was 1 mg per hour for 8
hours daily, the new basal rate of the furosemide is 2.5 mg per
hour for 8 hours daily. A user or a healthcare provider can change
the underlined numbers according to a person's sensitivity to
diuretics. The change of the protocol could occur automatically or
occur upon the approval of a user and/or healthcare
provider(s).
[0124] FIG. 30 illustrates wireless communication between a
diuretic pen 3001 and a remote control device 3002 which receives
biological parameter information from biological parameter
measurement device. Measured biological parameter may be input into
the diuretic pen wirelessly or manually. A user may input
biological parameter manually by using button(s), a knob, etc. As
shown in FIG. 31, the diuretic pen 3001 can contain a processor,
software, and telemetry system, though the diuretic pen may not
have all of these components or may have additional components. The
processor within the diuretic pen can compute the dose of diuretic
drug based on the biological parameter.
[0125] FIG. 32 illustrates examples of sensors/devices measuring
various biological parameters. These devices and/or sensors are
connected to a diuretic pen wirelessly in some embodiments. The
diuretic pen can compute the dose of diuretic injection based on
these biological parameters.
[0126] FIG. 33 shows possible data flow for computation of the
diuretics dose. In alternative embodiments, the processor uses
various other factors to compute diuretics dose. Examples include
physical signs, vital signs, bio markers, symptoms, intracardiac
pressure, intravascular pressure, intrathoracic electrical
impedance and NYHA classification, etc., as shown in FIG. 33. For
example, if B-type natriuretic peptide (BNP) is elevated, this may
indicate increased body fluid volume and congestive heart failure.
If BNP is above 100 pg/ml, the diuretic pen can increase (or
adjust) the dose of the diuretics.
[0127] FIG. 34 illustrates another embodiment of the present
invention. This figure shows another type of a drug dispensing
apparatus. One embodiment of this drug dispensing apparatus is a
pen-type apparatus 3406 which contains medication pills 3404. Some
embodiments of this pen-type apparatus contain drug suspension. For
example, a user may use this pen-type drug dispensing apparatus
3406 based on "sodium counting." "Sodium counting" is utilized when
a user or a processor of a device calculates the dosage of diuretic
based on the amount of sodium intake. For example, a user may be
instructed by a physician to use 2 mg of furosemide per 50 mg of
sodium intake. The pen-type apparatus might contain multiple 2 mg
or 1 mg furosemide pills, though various doses of furosemide can be
contained in the apparatus. If a user plans to eat 350 mg of
sodium, the user can take 14 mg of furosemide according to the
"sodium counting." Thus, 14 mg can be input into the pen-type
apparatus using a button 3407 and a knob 3401. When knob 3401 is
pushed, screw 3403 is moved to push the pills out of the drug
container. Screw 3403 movement is controlled by a processor in some
embodiments, though screw 3403 movement is controlled manually in
other embodiments. The dosage of 14 mg furosemide is not readily
available at a pharmacy because 14 mg is not a commonly used dose
of furosemide pill. If the pen-type apparatus contains 2 mg
furosemide pills, 7 furosemide tablets are taken out of the
dispenser. This pen-type drug dispensing apparatus makes it easy to
dispense various doses of diuretics and other medications. In one
embodiment, this pen-type diuretic dispensing apparatus contains a
processor which can compute the dose of diuretics when a user
inputs the amount of sodium or salt into the pen-type diuretic
dispensing apparatus. A user can input the amount of sodium or salt
using knob 3401 and/or buttons on the apparatus. In alternative
embodiments, when knob 3401 is pressed, a predetermined number of
pills are released out of the container 3406. For example, two
tablets of 1 mg furosemide pill can be released out of the
container when knob 3401 is pressed. The user may be instructed to
press the knob 3401 one time when the user plans to eat food with
low salt and/or water content, to press the knob 3401 twice when a
user plans to eat food with moderate salt and/or water content, or
press the knob 3401 three times when he plans to eat food with high
salt and/water content.
[0128] FIG. 35 illustrates another embodiment of the invention. In
this embodiment, a disposable external diuretic infusion pump 3501
is attached to the body 3505 of a user. This disposable external
diuretic infusion pump includes a reservoir that contains the
diuretic. This external diuretic infusion pump 3501 can be a
metered dose infusion pump. The external diuretic infusion pump
3501 is set to deliver a predetermined volume of a drug to the
user. When the user pushes a button 3502, a predetermined volume of
the drug is delivered via a cannula 3503 to the user. The tip of
the cannula 3503 is located subcutaneously in a preferred
embodiment. In some embodiments, a reservoir may be refilled
through a hole 3504. One example of a metered dose diuretic
infusion is as follows. If a user is expected to eat food that
contains salt, the user may be instructed to use this metered dose
diuretic infusion pump before or at the time of eating this food.
For example, a pump may deliver 1 mg of furosemide to the user each
time button 3502 is pressed. The user can be instructed to press
the button 3502 one time when the user plans to eat food with low
salt content, twice when the user plans to eat food with moderate
salt content, three times when the user plans to eat food with high
salt content. The user may be able to urinate and excrete salt
shortly after eating using this device system. People with heart
failure are instructed to avoid food with high salt content because
of body salt and fluid overload. This apparatus and method can
allow people to take an extra amount of salt/water and still
prevent them from developing salt/body fluid overload. The metered
dose diuretic infusion pump can deliver a diuretic based on
measured body weight. The user may be instructed to press the
button 3502 once when the measured body weight is 1 kg above target
weight, twice when the measured body weight is 1-2 kg above target
weight, and three times when the measured body weight is more than
2 kg above target weight. The metered dose drug infusion pump can
be implanted under skin in some embodiments.
[0129] FIG. 36 illustrates another embodiment. It can be important
to measure body weight and/or biological parameters regularly, to
take electrolyte supplements, such as potassium supplement or
magnesium supplement, and to measure blood pressure while a user
uses a diuretic infusion pump for safety reasons. As shown in FIG.
36, the user is asked if he took potassium supplement, measured his
body weight, and measured his blood pressure. If the user inputs
"yes," the diuretic infusion pump is programmed to continue
diuretic infusion. If the user inputs "no," the diuretic infusion
pump can be programmed to discontinue diuretic infusion until the
user inputs "yes." This feedback mechanism is a safety feature of
the diuretic infusion system.
[0130] FIG. 37 illustrates examples of sensors/devices measuring
various biological parameters. These devices and/or sensors are
connected to a remote control device wirelessly in some
embodiments. The remote control device can compute the dose of
diuretic injection based on these biological parameters.
[0131] FIG. 38 shows possible data flow for computation of the
diuretics dose. In alternative embodiments, the processor uses
various other factors to compute diuretics dose. Examples include
physical signs, vital signs, bio markers, symptoms, intracardiac
pressure, intravascular pressure, intrathoracic electrical
impedance and NYHA classification, etc. For example, if B-type
natriuretic peptide (BNP) is elevated, this may indicate increased
body fluid volume and congestive heart failure. If BNP is above 100
pg/ml, the remote control device can compute the dosage and
increase (or adjust) the dose of the diuretics.
[0132] A photograph of the user's legs or other parts of the body
can be taken by the diuretic infusion pump system by a camera or a
cell phone. The photograph can be transmitted to a healthcare
provider. The healthcare provider reviews the photograph of legs,
and may be able to verify the body fluid condition by comparing the
measured weight with the photograph. The diuretic infusion pump can
also have a built-in camera. The healthcare provider can detect
malfunction of the weight scale when the measured body weight is
far greater than the target weight but the photograph of the legs
does not show any swelling.
[0133] FIG. 39 illustrates another embodiment of the invention.
Urinary catheter 3905 is placed into a bladder of a human body
3902. Urinary catheter 3905 is connected with a drainage bag 3904.
The amount of urine output over a period of time can be measured
using this urinary catheter and drainage bag. In one embodiment,
the urine output measurement system can include a urinary catheter,
a drainage bag, a sensor to measure urine output, a transmitter, a
receiver, a processor, software, etc., though it can have fewer or
more components. The measured urine output over a predetermined
period of time is transmitted wirelessly or by other means (e.g.,
wired, manual data input, etc.) to a diuretic infusion pump 3901.
The diuretic infusion pump 3901 automatically adjusts the infusion
rate of diuretic based on the urine output in order to achieve a
target urine output. In alternative embodiments, the diuretic
infusion pump has a separate a remote control device, a portable
computer system, a PDA, etc., which can communicate wirelessly or
via other means (e.g., wired, manual data input, etc.) with the
urine output measurement system.
[0134] As one example, a physician programs the diuretic infusion
pump system to achieve 2400 ml of urine output over a 24-hour
period. In order to achieve this, a urine output of 100 ml per hour
is required on average over 24 hours. Various diuretic infusion
protocols shown in other figures may be programmed into the
diuretic infusion pump. The sensor of the urine output measurement
system measures the amount of the urine output. The transmitter of
the urine output measurement system transmits the urine output
information wirelessly or by other means (e.g., wired, manual data
input, etc.) to the diuretic infusion pump system and/or a separate
computer, a remote control device, etc. If the urine output over a
predetermined period of time is less than the target urine output,
the diuretic infusion pump can increase diuretic infusion to
increase urine output. If the urine output over a predetermined
period of time is greater than the target urine output, the
diuretic infusion pump can decrease diuretic infusion to decrease
urine output. If the urine output were 80 ml over one hour, the
diuretic infusion pump would increase the diuretic infusion to
achieve 120 ml over the next hour to achieve 100 ml per hour of
urine output. The diuretic infusion pump 3901 can deliver the
diuretic intravascularly, subcutaneously, intramuscularly, etc. In
one embodiment, the diuretic infusion pump 3901 can communicate
wirelessly or by other means (e.g., wired, manual data input, etc.)
with a non-invasive blood pressure monitoring system 3907. The
non-invasive blood pressure monitoring system 3907 can have a
processor, a controller, software, a wireless transmitter/receiver,
though it may have fewer or more components in alternative
embodiments.
[0135] When blood pressure is measured using a blood pressure cuff
3906, the measured blood pressure is transmitted wirelessly or by
other means (e.g., wired, manual data input, etc.) to the diuretic
infusion pump 3901. If blood pressure is below a predetermined
level, the diuretic infusion pump 3901 can stop the diuretic
infusion or adjust the diuretic infusion based on the program. This
system may reduce the risk of hypotension. If blood pressure is
above a predetermined level, the diuretic infusion pump 3901 can
increase diuretic infusion or adjust the diuretic infusion based on
the program.
[0136] In alternative embodiments, the urine output measurement
system comprises a urinary catheter, a urine drainage bag, and a
sensor to measure urine output, but does not include a wireless
transmitter and receiver. The user may input the urine output over
a certain period of time manually into a diuretic infusion pump
system and/or a separate computer or a remote control device. In
alternative embodiments, the diuretic infusion pump system can
communicate wirelessly or by other means (e.g., wired, manual data
input, etc.) with the urine output measurement system and other
biological parameter sensors (see other figures). The diuretic
infusion pump system can adjust the diuretic infusion to maintain
the target urine output, as well as to maintain the target
biological parameter (e.g., the target intravascular pressure, the
target intracardiac pressure, and/or the target intrathoracic
impedance).
[0137] FIG. 40 illustrates the operation of a diuretic infusion
system according to one embodiment. In FIG. 40, the urine output
measurement sensor and processor are onboard, within a housing of
the urine output measurement apparatus. The urine output
measurement sensor is electrically connected to the processor, and
sends the measured urine output to the processor. The processor is
connected to a telemetry system and a signal transmitter. The urine
output information is sent from the telemetry system of the urine
output measurement apparatus via the transmitter.
[0138] The urine output information signal is received by a
receiver of the diuretic infusion pump. The receiver of the
diuretic infusion pump is electrically connected to a processor
which is housed in the diuretic infusion pump. The processor
receives the urine output information and performs computations to
determine the diuretic infusion rate, such as basal rate and bolus
rate, according to programmed parameters, protocols and algorithms.
The processor controls an electric motor to deliver diuretic from a
reservoir to a user through an outlet, a tube, and an infusion set
of the diuretic infusion pump. In alternative embodiments, the user
manually inputs measured urine output into the diuretic infusion
device. This urine output information enters a processor which is
housed in the diuretic infusion pump. The processor performs
computations to determine the diuretic infusion rate as described
with regard to other figures.
[0139] FIG. 41 illustrates the wireless operation of the diuretic
infusion pump system. The urine output measurement system 4101
includes a urine output measurement sensor 4102, a processor 4103,
and a wireless transmitter 4104 (or a wireless receiver), a urinary
catheter, a urine drainage apparatus, and an antenna 4105. The
transmitter 4104 sends signals 4106 that contain urine output
information.
[0140] The urine output signal(s) can be sent to different
receivers. The diuretic infusion pump receives the signal(s) 4106
through an onboard receiver 4108 via an antenna 4107. A handheld
communication device, such as a remote control device, an iPOD.TM.,
an MP3 player, a handheld computer, or a portable phone may receive
the signal 4106 through an onboard receiver 4112 via an antenna
4111. The user may choose to send information to a computer or
handheld communication device for the purpose of saving urine
output information on the computer or connecting with the Internet
to send urine output information to healthcare providers. The
diuretic infusion pump system and/or handheld communication device
can receive biological parameter signal(s) wirelessly or by other
means (e.g., wired, manual data input, etc.) from the biological
parameter sensor, transmitter, or processor 4110. FIG. 38 provides
examples of biological parameters.
[0141] FIG. 42 illustrates an example of furosemide infusion
protocol based on urine output.
[0142] FIG. 43 illustrates an ambulatory diuretic infusion pump
4301 mounted at a pole 4310. A diuretic contained in a bag 4303 is
infused into a vein of a patient 4305 through an intravenous tube
system 4304. The diuretic infusion pump 4301 contains a controller
which adjusts the rate of diuretic infusion based on urine output
and/or other biological parameter(s). A user can input the urine
output measured by urine output measurement system 4308, 4309 using
a keypad 4302 or using a remote controller. The urine output
measured by the urine output measurement system can be transmitted
wirelessly to the diuretic infusion pump 4301 in another
embodiment. The blood pressure measured by blood pressure
measurement system 4306, 4307 can be manually input into the
diuretic infusion pump 4301 or transmitted wirelessly into the
diuretic infusion pump 4301.
[0143] FIG. 44 illustrates an ambulatory diuretic infusion pump
4401 mounted at a pole 4402. A diuretic contained in a bag 4406 is
infused into a vein of a patient 4404 through intravenous tube
system 4403. The diuretic infusion pump 4401 contains a controller
which adjusts the rate of diuretic infusion based on weight and/or
other biological parameters. A user can input the weight measured
by weight measurement scale 4405 into the diuretic infusion pump
4401 using a keypad. 4407 or using a remote control device. The
weight measured by the scale 4405 can be transmitted wirelessly to
the diuretic infusion pump in another embodiment.
[0144] Even though the term "diuretic infusion pump" (or "diuretic
infusion system" or similar variants) is used in this application,
one of ordinary skill in the art would know that this term is not
limited to the use of diuretics, but can also use other types of
drugs, as well. Thus, this term is not limited to diuretics. Many
different drugs can be used for the diuretic infusion pump.
Examples of such drugs are described in other parts of the
application.
[0145] Diuretic infusion pumps can contain two reservoirs in some
embodiments. One reservoir can contain furosemide. The other
reservoir can contain buffering solution. Buffering solution
includes (but is not limited to) sodium chloride solution, Lactated
Ringer's solution, or Dextrose 5% solution. Some furosemide
solution may have a high pH of about 9. Mixing a furosemide
solution with a sodium chloride solution, Lactated Ringer's
solution or Dextrose 5% solution may lower the pH of the furosemide
solution.
[0146] Furosemide discolors when it is exposed to light. Discolored
furosemide is not recommended to be used. A reservoir and cartridge
within a diuretic infusion pump may be light resistant to protect
furosemide or other drugs from being exposed to the light.
[0147] In all of the above embodiments, the diuretic infusion pump
was located external to the body. However, alternatively, internal
and implantable diuretic infusion pumps may also be made. The
diuretic infusion pumps are also shown as portable in the above
description. In alternative embodiments, the diuretic infusion pump
may not be portable.
[0148] In another aspect of the invention, a user of the diuretic
infusion pump may choose to use the device for long term or may
choose to use it for short term when his body weight changes. The
diuretic infusion pump can also be used in various locations: home,
outpatient facilities and hospitals, as well as the intensive care
unit.
[0149] Programs and protocols coupled with the diuretic infusion
pump preferably have various safety measures to minimize side
effects of diuretics. One example of a safety measure is that the
diuretic infusion pump stops infusing diuretics when a user does
not measure body weight in a certain period after previous weight
measurements. For example, the diuretic infusion pump may be
programmed to stop diuretic infusion in two days if the diuretic
infusion pump does not receive a new body weight measurement. This
safety measure helps to avoid using inappropriately high dose of
diuretics when previously measured body weight is higher than
actual body weight. Alarms and display on the screen may be
programmed to request a user to enter a new body weight measurement
into the diuretic infusion pump.
[0150] The above description and illustration of preferred
embodiments of the invention has been presented to provide
illustration and description. It is not intended to limit the
invention to the precise forms that are disclosed. Many variations
and modifications will be apparent to people skilled in this
art.
[0151] Depending on the form of the components, "coupling" or
"connection" between components may take different forms. Dedicated
circuitry can be coupled to each other by hardwiring or by
accessing a common register or memory location, for example.
Software "coupling" can occur by any number of ways to pass
information between software components (or between software and
hardware, if that is the case). The term "coupling" is meant to
include all of these and is not meant to be limited to a hardwired
permanent connection between two components. In addition, there may
be intervening elements. For example, when two elements are
described as being coupled to each other, this does not imply that
the elements are directly coupled to each other nor does it
preclude the use of other elements between the two.
* * * * *