U.S. patent application number 12/202068 was filed with the patent office on 2009-03-05 for control of body fluid condition using diuretics, based on weight measurement.
Invention is credited to Sang Hoon Woo.
Application Number | 20090062728 12/202068 |
Document ID | / |
Family ID | 40387869 |
Filed Date | 2009-03-05 |
United States Patent
Application |
20090062728 |
Kind Code |
A1 |
Woo; Sang Hoon |
March 5, 2009 |
Control of Body Fluid Condition Using Diuretics, Based on Weight
Measurement
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 the measured weight of the
patient. For example, this weight can be transmitted wirelessly to
a portable diuretic infusion device attached to the patient.
Inventors: |
Woo; Sang 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.: |
12/202068 |
Filed: |
August 29, 2008 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
60967025 |
Sep 1, 2007 |
|
|
|
60979634 |
Oct 12, 2007 |
|
|
|
60986974 |
Nov 9, 2007 |
|
|
|
60988375 |
Nov 15, 2007 |
|
|
|
61048113 |
Apr 25, 2008 |
|
|
|
Current U.S.
Class: |
604/66 |
Current CPC
Class: |
A61M 5/1723 20130101;
A61M 2202/0496 20130101; A61M 2205/05 20130101; A61M 5/16827
20130101; A61M 5/14276 20130101; A61M 5/14244 20130101; A61M
2205/3569 20130101 |
Class at
Publication: |
604/66 |
International
Class: |
A61M 5/168 20060101
A61M005/168 |
Claims
1. A portable diuretic infusion device comprising: a reservoir for
holding diuretic; a pump connected to the reservoir and connectable
to a human patient, for infusing diuretic from the reservoir into
the patient; and a controller that controls the pump based on a
measured weight of the patient, thereby controlling a rate of
infusion of the diuretic based on the measured weight of the
patient.
2. The device of claim 1 further comprising: a wireless receiver
coupled to the controller, for wirelessly receiving weight
information about the patient.
3. The device of claim 1 further comprising: a user interface that
allows a user to input weight information about the patient.
4. The device of claim 1 wherein the controller adjusts the rate of
infusion based on a measured weight of the patient to maintain a
target weight for the patient.
5. The device of claim 1 further comprising: a second reservoir for
holding a second medication, the pump further for infusing the
second medication from the reservoir into the patient.
6. The device of claim 1 further comprising: a second reservoir for
holding a second medication; and a second pump connected to the
second reservoir and connectable to the patient, for infusing the
second medication from the second reservoir into the patient.
7. The device of claim 1 wherein the controller adjusts the rate of
infusion additionally based on a measured pressure within a cardiac
chamber of the patient.
8. The device of claim 1 wherein the controller adjusts the rate of
infusion additionally based on a measured pressure within a blood
vessel of the patient.
9. The device of claim 1 wherein the controller adjusts the rate of
infusion additionally based on a measured pressure within a cardiac
chamber and/or a blood vessel of the patient to maintain a target
pressure in the cardiac chamber and/or blood vessel.
10. The device of claim 1 wherein the controller adjusts the rate
of infusion additionally based on a measured biomarker.
11. The device of claim 10 wherein the biomarker is one of an
atrial natriuretic peptide, a brain natriuretic peptide, and a
NT-pro brain natriuretic peptide.
12. The device of claim 1 wherein the controller adjusts the rate
of infusion additionally based on the amount of salt, sodium and/or
water content of food.
13. The device of claim 1 wherein the controller adjusts the rate
of infusion additionally based on blood pressure measured
non-invasively.
14. The device of claim 1 wherein the controller adjusts the rate
of infusion additionally based on intrathoracic electrical
impedance.
15. The device of claim 1 wherein the controller stops infusion if
measured weight is not input after a predetermined period of
time.
16. The device of claim 1 wherein the portable diuretic infusion
device is disposable.
17. A diuretic infusion system comprising: a weight measurement
apparatus comprising: a weight sensor for measuring a body weight
of a human patient; and a wireless transmitter for wirelessly
transmitting weight information based on the measured body weight;
and a portable diuretic infusion device comprising: 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; a wireless receiver for wirelessly receiving the weight
information transmitted from the weight 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
weight information.
18. A weight measurement apparatus comprising: a weight sensor for
measuring a body weight of a human patient; and a processor coupled
to the weight sensor, for calculating a dose of diuretic based on
the measured weight; and a display coupled to the processor, for
displaying the calculated dose.
19. A diuretic infusion system comprising: a weight measurement
apparatus comprising: a weight sensor for measuring a body weight
of a human patient; and a wireless transmitter for wirelessly
transmitting weight information based on the measured body weight;
and a portable diuretic infusion device comprising: 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; a controller that controls the pump, thereby controlling a
rate of infusion of the diuretic; and a wireless receiver for
wirelessly receiving one or more commands; and a remote control
device comprising: a wireless receiver for wirelessly receiving the
weight information transmitted from the weight measurement
apparatus; a wireless transmitter for wirelessly transmitting one
or more commands to the portable diuretic infusion device; and 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 weight information.
20. A diuretic infusion system comprising: a weight measurement
apparatus comprising: a weight sensor for measuring a body weight
of a human patient; and a diuretic infusion device comprising: 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
based on the measured body weight, thereby controlling a rate of
infusion of the diuretic based on the measured body weight.
21. The device of claim 20 wherein the pump is a portable pump.
22. The device of claim 20 wherein the pump is a non-portable
pump.
23. The device of claim 20 wherein the pump is an ambulatory drug
infusion pump.
24. The device of claim 20 wherein the pump is an implantable drug
infusion pump.
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 the measured weight of the patient.
This weight 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,
thereby controlling the rate of infusion of the diuretic or other
drug.
[0015] The controller adjusts the rate of infusion based (at least
in part) on a measured weight of the patient. For example, the
protocol may be designed to maintain a target weight for the
patient, so that more diuretic is infused when the patient is over
the target weight and less diuretic is infused when the patient is
under the target weight. In another aspect, the patient's weight
can be measured and then wirelessly transmitted to the diuretic
infusion device. The controller on the diuretic infusion device
receives the weight information and automatically adjusts the
infusion rate.
[0016] In another aspect of the invention, the weight information
is not used to automatically control a diuretic pump. Rather, it is
used to automatically calculate the correct dose of diuretic and
this is displayed to the patient. In one approach, a weight
measurement apparatus (e.g., a scale) includes a weight sensor, a
processor and a display. The weight sensor measures the body weight
of the patient. The processor calculates the corresponding dose of
diuretic based on the measured weight. The dose is shown to the
patient on the display. It could also be shown on other devices,
such as a computer, cell phone, PDA, etc.
[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 (non-weight) biological parameter of a human patient.
The diuretic is dispensed based on the weight measurement and the
measurement of the additional biological parameter(s).
[0018] In other aspects of the invention, the portable diuretic
infusion device is a metered dose diuretic infusion pump. This pump
can include a reservoir for holding diuretic, and a pump connected
to the reservoir and connectable to a human patient for infusing
diuretic from the reservoir into the patient.
[0019] In further embodiments, the diuretic infusion system is
remote control operated. The system can include a weight
measurement apparatus having a weight sensor for measuring a body
weight of a human patient and a wireless transmitter for wirelessly
transmitting weight information based on the measured body weight.
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 weight
information transmitted, a wireless transmitter for wirelessly
transmitting one or more commands to the portable diuretic infusion
device, and a controlled 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 weight
measurement apparatus, the portable diuretic infusion device, and
the remote control device.
[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-a depicts a diuretic infusion system.
[0025] FIGS. 1-b depicts a wireless diuretic infusion system.
[0026] FIG. 2 depicts a more detailed view of a diuretic infusion
device.
[0027] FIG. 3 illustrates operation of a diuretic infusion
system.
[0028] FIG. 4 shows a protocol for use with a diuretic infusion
system.
[0029] FIGS. 5 and 6 illustrate operation of a diuretic infusion
system.
[0030] FIG. 7 is a block diagram of a diuretic pump.
[0031] FIGS. 8-a and 8-b is a mechanical depiction of a diuretic
pump.
[0032] FIG. 9 illustrates wireless operation of a diuretic infusion
system.
[0033] FIG. 10 illustrates operation of a non-wireless diuretic
infusion system.
[0034] FIG. 11 is a mechanical depiction of a diuretic pump with
two reservoirs.
[0035] FIGS. 12 and 13 illustrate diuretic dispensing without a
diuretic infusion device.
[0036] FIG. 14 illustrates infusion of diuretic into the body.
[0037] FIG. 15 is a mechanical depiction of another diuretic
pump.
[0038] FIGS. 16-18 further illustrate operation of further
embodiments for diuretic dispensing.
[0039] FIGS. 19-29 show additional protocols for diuretic
dispensing.
[0040] FIGS. 30 and 31 illustrate further embodiments for a
diuretic infusion system.
[0041] FIGS. 32-35 show additional protocols for diuretic
dispensing.
[0042] FIG. 36 illustrates another diuretic infusion system
including an electric scale.
[0043] FIGS. 37-40 show protocols for use with the diuretic
infusion system of FIG. 36.
[0044] FIG. 41 illustrates another diuretic infusion system
including a remote control device.
[0045] FIG. 42 illustrates a more detailed view of the diuretic
infusion device and the remote control device.
[0046] FIG. 43 illustrates the operation of a closed loop drug
infusion system for a diuretic infusion pump system.
[0047] FIG. 44 illustrates wireless communication of a diuretic
infusion pump system with biological parameter measurement
apparatuses.
[0048] FIGS. 45-a and 45-b illustrate additional drug-infusion
protocols
[0049] FIG. 46 illustrates a diuretic injecting pen-type
device.
[0050] FIG. 47 illustrates a wirelessly-operated diuretic injecting
pen-type device.
[0051] FIG. 48 illustrates the components of the diuretic injecting
pen-type device.
[0052] FIG. 49 illustrates examples of the biological parameters
measured by devices or sensor communicatively coupled to the
diuretic injecting pen-type device.
[0053] FIG. 50 illustrates another type of drug-dispensing pen-type
apparatus for dispensing pills.
[0054] FIG. 51 illustrates the drug-dispensing pen-type apparatus
in wireless communication with a weight measurement apparatus.
[0055] FIG. 52 illustrates a disposable external diuretic infusion
pump.
[0056] FIG. 53 shows another embodiment of a diuretic infusion pump
with a feedback mechanism.
[0057] FIGS. 54 and 55 show various biological parameters and
factors that may be used with various embodiments, such as that of
FIG. 42.
[0058] FIG. 56 illustrates another diuretic infusion system using
an ambulatory diuretic infusion pump.
[0059] 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
[0060] FIG. 1-a 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. FIG. 1-b depicts another embodiment. The
weight sensor 103 communicates with the diuretic infusion device
101, in this example using a wireless communications channel.
Weight information, for example body weight, body weight change,
past body weight measurements and/or body weight trends, is
transferred from weight sensor 103 to the diuretic infusion device
101 via the wireless communication. The diuretic infusion device
101 uses this information to adjust the rate of diuretics infusion
to the patient 102.
[0061] Various wireless technologies may be used. Examples include
Bluetooth, WiFi, Wimax, other RF (radio frequency) technologies,
and infrared and optical technologies. Wireless transmitters and
receivers may be built into the weight sensor 103 and diuretic
infusion device 101. The sensor 103 and diuretic infusion device
101 may communicate directly with each other, or through
intermediary devices such as a remote control device, a separate
computer system (for example, accessible by the patient and/or his
healthcare professional). The computer system may save information
from weight sensor 103 and/or diuretic infusion device 101 to allow
further analysis.
[0062] In one implementation, the weight sensor 103 is activated by
the patient (e.g., by stepping onto a scale), and patients who tend
to accumulate body fluid due to heart disease, kidney disease or
liver disease are instructed to measure body weight frequently
using the weight sensor 103. In an alternate embodiment, the weight
sensor may be located so that it is automatically activated. For
example, the weight sensor may be located in the patient's bed or
as part of a chair that the patient uses regularly. The weight
sensor 103 and/or diuretic infusion device 101 may also obtain
other types of relevant information, such as the time of day of the
weight measurement. In this way, weight measurements can be time
stamped and the time stamp may be used to account for cyclical
variations in body weight.
[0063] Body weight measurements may also be tagged with the
patient's identification so that multiple patients can conveniently
use the same weight sensor 103. In one approach, the diuretic
infusion device 101 or other device 101 identifies the patient to
the weight sensor 103, which then tags the weight information with
the patient's identification. Alternately, the weight sensor 103
may broadcast the weight information, and the diuretic infusion
device 101 has the responsibility to associate the weight
information with the correct patient.
[0064] 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.
[0065] 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. 7 for further
detail). The diuretic infusion pump 201 may not include the
wireless communications chip in alternative embodiments.
[0066] 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.
[0067] 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.
[0068] 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.
[0069] FIG. 3 illustrates operation of a diuretic infusion system.
Screen 303 on the diuretic infusion pump 305 displays information
related to use of the diuretic infusion pump. Dry weight or target
weight is an important parameter which is often used in clinical
settings. At dry weight or target weight, patients likely do not
have signs of volume overload such as swelling of legs or shortness
of breath. When weight is above dry weight or target weight, this
may indicate there is excessive fluid inside the body. When weight
is below dry weight or target weight, this may indicate a patient
is dehydrated. Maintaining body weight near dry weight or target
weight may be effective in preventing heart failure exacerbation
due to body fluid overload.
[0070] This figure illustrates a patient whose weight is 73 kg, 3
kg above the target weight of 70 kg. Weight measurement apparatus
301 also displays the weight of the user on the screen 302. This
body weight is transmitted from the weight measurement apparatus
301 to diuretic infusion pump 305 via wireless communications. Once
the diuretic infusion pump 305 receives a signal from the weight
measurement apparatus 301, the weight information is decoded.
Software coupled with the processor controls at least in part, the
operation of the diuretic infusion pump. More than one processor
may be used to control the diuretic infusion system. A pumping
system controls the transfer of diuretics from a reservoir or a
diuretic cartridge to the tubing system and a cannula.
[0071] The pumping system is controlled by a processor. In FIG. 3,
diuretic infusion pump 305 displays that target weight is 70 kg and
current weight is 73 kg. Software is programmed to calculate a
corresponding diuretics continuous infusion rate and bolus rate. In
this example, the diuretic infusion pump is programmed to increase
the diuretics infusion rate in order to increase excretion of body
fluid and urine output. The previous basal rate was set at 1 mg per
hour. FIG. 3 shows that the basal infusion rate is increased from 1
mg per hour to 1.5 mg per hour.
[0072] The user preferably is instructed to measure weight
frequently and on a regular basis. At a later weighing, if the body
weight is still above target weight but less than weight on the
previous measurement, the same infusion rate of diuretics may be
programmed to continue. If the body weight returns to the target
weight, the infusion rate of the diuretic infusion pump may be
programmed to decrease to prevent dehydration.
[0073] Various protocols on diuretics infusion can be programmed
and/or stored in the processor onboard the diuretic pump, as will
be described in more detail below. This is advantageous compared to
a conventional approach where a doctor gives instructions to the
patient, because patients often do not follow these instructions
and more complex protocols can be carried out by the diuretic pump
than by most patients.
[0074] Buttons on the keypad 304 of the diuretic infusion pump can
be used to program an onboard processor and adjust settings on a
diuretic infusion pump. The diuretic infusion pump may also be
programmed by using a computer system such as a desktop computer, a
portable computer, a portable phone or a remote control.
[0075] FIG. 4 shows a protocol for use with a diuretic infusion
system. In order to maintain body weight at the previously set
target weight or dry weight, the diuretic infusion pump adjusts the
diuretics infusion rate, which likely changes urine output.
Examples for two commonly prescribed diuretics--furosemide and
bumetanide--are illustrated. Referring to FIG. 4, the weight
measurement sensor measures body weight. This information is
transmitted wirelessly to the diuretic infusion pump.
[0076] The onboard program of the diuretic infusion pump calculates
the difference between target weight and current weight. If the
measured body weight is more than 3 kg above target weight (which
may suggest there are approximately 3 kg of extra water inside a
body), the diuretic infusion pump is programmed to increase the
basal rate of diuretics infusion by 100% from the initial basal
rate to increase urine output and excrete excess water and salt. If
the measured body weight is 2-3 kg above target weight, the
diuretic infusion pump is programmed to increase the basal rate of
diuretics infusion by 75% from the initial basal rate to increase
urine output. If the measured body weight is 1-2 kg below target
weight, this may suggest dehydration. The diuretic infusion pump is
programmed to decrease the basal rate of diuretics infusion by 75%
from the initial basal rate. The basal rate is the continuous
infusion rate of a diuretic medication that may be set by a doctor
or a user. Bolus is rapid infusion of a diuretics medication to
expedite the effect to increase urine output rapidly by increasing
drug concentration level in the blood. The diuretic infusion pump
may be programmed to use both basal rate and bolus, or to use only
one infusion method, either basal rate or bolus.
[0077] Conventional methods and technologies for basal infusion and
bolus infusion may be used. If the patient does not want to carry
the diuretic infusion pump constantly, this patient may choose
bolus infusion method only. This user may remove the diuretic
infusion pump after bolus infusion and reinsert it when diuretic
needs to be infused. An alarm may sound to notify a user when it is
time to infuse drug. A user may want to use basal infusion until a
certain time of day (like in the evening) for lifestyle purpose. If
basal infusion of furosemide stops at 7 pm for example, the effect
of furosemide may stop around 10-12 pm. This method may help
patients to avoid urinating in the middle of the night, which is a
common problem for people who take oral diuretic pills at night.
The diuretic infusion pump may be programmed by using software
built in the diuretic infusion pump and/or by using software in a
separate computer that communicates with the diuretic pump via a
wireless communication or non-wireless communication (using a
cradle, port, cable, etc).
[0078] One example of a case is as follows. A doctor may program a
diuretic infusion pump as follows: [0079] Diuretics--furosemide (10
mg/ml) [0080] Initial basal rate--1 mg per hour [0081] Duration of
basal rate--start at 7 AM and end at 7 PM [0082] Maximum basal
rate--5 mg per hour [0083] Bolus infusion--10 mg over 10 minutes at
7 AM and 4 PM [0084] Maximum bolus infusion per each infusion--60
mg [0085] Maximum daily dose combining basal rate and bolus--200 mg
[0086] Target weight--70 kg. [0087] If body weight is more than 3
kg above target weight, increase basal rate by 100% from initial
basal rate and provide bolus infusion of 40 mg at 7 AM and 4 PM.
[0088] If body weight is 2-3 kg above target weight, increase basal
rate by 75% from initial basal rate and provide bolus infusion of
30 mg at 7 AM and 4 PM. [0089] If body weight is 1-2 kg above
target weight, increase basal rate by 50% from initial basal rate
and provide bolus infusion of 20 mg at 7 AM and 4 PM. [0090] If
body weight is 0-1 kg above target weight, increase basal rate by
25% from initial basal rate and provide bolus infusion of 10 mg at
7 AM and 4 PM. [0091] If body weight is 0-1 kg below target weight,
decrease the basal rate by 50% from initial basal rate and provide
bolus infusion of 5 mg at 7 AM. [0092] If body weight is 1-2 kg
below target weight, decrease the basal rate by 75% from initial
basal rate and hold bolus infusion. [0093] If body weight is more
than 2 kg below target weight, stop basal rate and bolus infusion
and instruct a user to contact his/her doctor.
[0094] Let's say a patient measures his weight on a weight
measurement apparatus and finds out that his weight is 3.1 kg above
the previously set target weight of 70 kg. Following the programmed
furosemide protocol shown on FIG. 4, the diuretic infusion pump
increases its basal rate from 1 mg per hour to 2 mg per hour and
provides 40 mg furosemide at 7 AM and 4 PM as a bolus infusion.
Bolus infusion is programmed to be infused over 10 minutes. The
duration of bolus infusion may be adjusted using the keypad.
Maximum basal and bolus rate may be set and may be adjusted by a
user. This maximum rate may be set as upper limit of daily
diuretics dose, upper limit of bolus diuretics dose per each
infusion, upper limit of basal rate, and/or upper limit of weekly
diuretics dose. Setting these limits of diuretics infusion dose may
help to minimize side effects of diuretics such as dehydration,
electrolytes imbalance like hypokalemia, hypotension and kidney
failure.
[0095] In certain embodiments, the diuretic infusion device has the
capacity to deliver 0-10 ml/hour in basal rate and up to 40 ml per
bolus of furosemide (10 mg/ml). Alternatively, the diuretics
infusion device may use other diuretics such as bumetanide,
torsemide, ethacrynic acid, chorothiazide, other concentrations,
other diuretics and other classes of medications as previously
mentioned. In an alternate embodiment, the diuretic infusion device
has the capacity to deliver 0-10 ml/hour in basal rate and up to 10
ml per bolus of bumetanide (1 mg/ml). In another embodiment, the
diuretic infusion pump may have a capacity to deliver 0-20 ml/hour
in basal rate and up to 40 ml per bolus of furosemide (10 mg/ml).
In alternative embodiments, different basal rate ranges and
different bolus rate ranges may be used.
[0096] FIGS. 5 and 6 illustrate operation of a diuretic infusion
system. In FIG. 5, the weight measurement sensor and processor are
onboard within a housing of a weight measurement apparatus. The
weight measurement sensor is electrically connected to the
processor and sends the measured weight to the processor. The
processor is connected to a telemetry system and a signal
transmitter. The weight information is sent from the telemetry
system of the weight measurement apparatus via the transmitter.
[0097] The weight 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 weight
information and performs computations to determine 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 an alternative embodiment, a user
manually inputs measured weight into a diuretic infusion device.
This weight information enters a processor which is housed in the
diuretic infusion pump. The processor performs computations to
determine diuretic infusion rate in a manner similar to that
described above.
[0098] In FIG. 6, if the measured weight is same as the target
weight, the processor controls the electric pump to continue the
current diuretic infusion rate. If the measured weight is different
from the target weight, the program determines if the measured
weight is greater or less than the target weight. If the measured
weight is greater than the target weight, the processor computes
the diuretic infusion rate according to its program and increases
the rate of diuretic infusion. If the measured weight is less than
the target weight, the processor computes the diuretic infusion
rate according to its program and decreases the rate of diuretic
infusion. The target weight may be the same as dry weight or
different from dry weight, depending on the user.
[0099] FIG. 7 is a block diagram of a diuretic pump. Processor 701
(the controller) is contained in the interior of the housing 716 of
the diuretic infusion pump. The housing 716 may be made of plastic
or steel, for example. Processor 701 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.
[0100] The processor 701 is in electrical communication with an
electric motor and pump 713. The processor controls the electric
motor 713 according to its program. The processor also controls a
screen 704, an audible alarm 707, vibratory alarm 708 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 701.
Alternately, weight information may be input into the diuretic
infusion pump manually by a user, for example from a keypad or a
remote controller.
[0101] In this example, flash memory 714 and SRAM 715 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.
[0102] The user may program the processor 701 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 701.
[0103] 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 703. 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.
[0104] 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.
[0105] In FIG. 7, a keypad 709 is located on the housing 716. A
touch screen input device may also be used. The keypad 709 shown in
FIG. 2 includes buttons 203, 202 to provide input to the processor
701.
[0106] 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 712 may be used to detect the motion of a
gear in the drive mechanism for the pump. Cartridge sensor or
reservoir sensor 711 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.
[0107] 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.
[0108] 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.
[0109] 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 716 of the diuretic
infusion pump.
[0110] Not all embodiments require all of the components described
above.
[0111] FIG. 8-a and 8-b are mechanical depictions of a diuretic
pump. The diuretic infusion pump contains a processor 801. The
processor is electrically connected or otherwise communicatively
coupled to an electric motor 802, for example a DC motor with
gear-reducer. The processor 801 controls the electric motor 802
according to its programming. The electric motor 802 is connected
to a peristaltic pump 804. The peristaltic pump 804 has a rotor
inside. A flexible tube inside the peristaltic pump 804 is
connected with a tube 805 and 808. 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 803
to a user via the infusion tube 808. In order to detect if the
diuretics solution is depleted and needs to be replaced or
refilled, a sensor 809 can be used. FIG. 8-b is a simplified
mechanical depiction of a syringe pump system. The pump housing 815
contains a syringe 816. The syringe 816 contains diuretics. The
processor 810 is electrically connected or otherwise
communicatively coupled to an electric motor 811. The processor 810
controls the electric motor 811 according to its programming. The
motor 811 rotates a motor gear which moves a screw 813 axially. A
screw 813 is configured to move axially to push a plunger 814
inside a syringe and push diuretics out of a syringe 816 or a
reservoir through an infusion tube 818 and a cannula 819. 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 805, 808 and the infusion set.
Technologies used in insulin pumps may be used also for diuretic
pumps.
[0112] 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.
[0113] 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.
[0114] FIG. 9 illustrates wireless operation of a diuretic infusion
system. The weight sensing apparatus 901 includes a weight sensor
902, a processor 903, and a wireless transmitter 904 (or wireless
receiver) and antenna 905. The transmitter 904 sends signals 906
that contain weight information.
[0115] The weight signal may be sent to different receivers.
Diuretic infusion pump receives the signal 906 through an onboard
receiver 908 via an antenna 907. A computer such as a home (or
physician office) desktop computer or portable computer may receive
the signal 906 through an onboard receiver 910 via antenna 909. A
handheld communication device such as an iPod, MP3 player, handheld
computer, remote control device, or portable phone may receive the
signal 906 through onboard receiver 912 via an antenna 911. A user
may choose to send information to a computer or handheld
communication device for the purpose of saving weight information
into the computer or connecting with the internet to send weight
information to healthcare providers.
[0116] FIG. 10 illustrates operation of a non-wireless diuretic
infusion system. In this embodiment, there is no wireless
communication between diuretic infusion pump 1005 and a scale 1001.
Instead, a user weighs his weight using the scale 1001. The user
manually inputs the measured weight into the diuretic infusion pump
using a keypad on the diuretic infusion pump (or other input
device). In this example, the measured weight (73 kg) on the scale
1001 is shown on the display 1002. The user inputs 73 kg into the
diuretic infusion pump weight using the keypad.
[0117] The keypad 1009 may have various buttons which are used for
particular functions and programming. For example, button 1006 has
"S" sign on it and it is used to select a particular menu, number,
letter, protocol, medication etc. Button 1004 has "M" sign on it
and it is used to show menus, protocols, numbers, letters,
medications, etc on the screen 1003 that can be selected using the
"S" button. Buttons 1007 and 1008 are used to scroll menus,
protocols, numbers, letters and medications up 1008 or down
1007.
[0118] In addition to processor control of the infusion rate, the
user may be able to adjust the infusion rate manually using the
keypad. If the user wants to increases infusion rate more than what
is recommended or programmed by the program, or if the user wants
to decrease infusion rate less than what is recommended or
programmed by the program, the user manually adjusts the rate using
the M button 1004, scroll buttons 1007, 1008 and/or S button
1006.
[0119] FIG. 11 is a mechanical depiction of a diuretic pump with
two reservoirs: in this case a diuretics reservoir 1101 and an
insulin reservoir 1102. 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 1103, 1104
inside an ambulatory infusion pump and leaves the housing of the
pump via a tube 1109 outside the ambulatory infusion pump. There
may be two separate channels within the tube 1109 through which
each medication is delivered separately. Each medication is
delivered to a user through different holes 1111, 1112. In
alternative embodiments, a syringe pump system can be used instead
of a peristaltic pump 1106. Two syringes can have separate electric
motors that control the movement of the plunger of the respective
syringes and release of each medication.
[0120] 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 1110 controls an electric
motor 1105 and a pump 1106 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.
[0121] FIGS. 12 and 13 illustrate diuretic dispensing without a
diuretic infusion device. Here, a user takes diuretic pills
according to displayed instructions on the screen of the scale or
separate display device. A weight measurement sensor detects the
weight of the user. This weight measurement sensor is electrically
connected to a processor. The processor computes a diuretic pill
dosage according to its program. Instructions 1303 are displayed on
a screen 1302 of the electric scale 1301, as shown in FIG. 13. A
separate display device may contain a wireless communication chip,
a transmitter/receiver, and a processor, and may perform the
computation of drug dosage when weight information enters the
processor.
[0122] In this example, the measured weight is 3 kg above the
target weight of 70 kg. The processor computes the diuretics pill
dosage and displays instructions on the screen to increase the dose
of furosemide from 10 mg twice a day to 20 mg twice a day. An
example protocol is the following: [0123] If body weight is more
than 2 kg above target weight, increase the dosage of diuretics by
100%. [0124] If body weight is 1-2 kg above target weight, increase
the dosage of diuretics by 50%. [0125] If body weight is 0.5-1 kg
above target weight, increase the dosage of diuretics by 25%.
[0126] If body weight is 0-0.5 kg above target weight, hold
diuretics. Another example of oral furosemide dose titration
protocol is shown in FIG. 19.
[0127] FIG. 14 illustrates infusion of diuretic into the body. In
FIG. 2, diuretic medication is infused into subcutaneous tissue. In
alternative embodiments shown in FIG. 14, diuretic medication may
be infused into a peritoneal cavity, an intravascular space (e.g.,
into a vein) or intramuscularly. The diuretic infusion pump 1407
attaches to a tubing system 1406, an adhesive 1405 and a needle
1403.
[0128] A plastic tube 1401 (a catheter) is attached to a silicone
bubble 1404 (septum). Tip 1408 of the plastic tube may be located
into a peritoneal space or a vein (or an artery). A needle 1403 is
inserted into the silicone bubble. Medication is delivered from the
infusion pump 1407 through a tubing system 1408, a needle 1403 and
a plastic tube 1401 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 1402 and silicone bubble 1404 may be located in
subcutaneous tissue or may be located outside the skin.
[0129] FIG. 15 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.
[0130] FIG. 11 shows an infusion pump with two drug reservoirs
1101, 1102 that share one pump 1106. FIG. 15 shows two peristaltic
pumps 1503, 1504 connecting with two different reservoirs 1501,
1502. A processor 1505 is electrically connected with electric
motors 1511, 1512. The processor 1505 controls these electric
motors 1511, 1512 and pumps 1503, 1604 to deliver medication from
each medication reservoir 1501, 1502. The pump 1503 is connected
with a reservoir 1501 and delivers a medication from a reservoir
1501 through a tubing system 1506, 1508 to a user. The pump 1504 is
connected with the reservoir 1502 and delivers medication from the
reservoir 1502 through a tubing system 1507, 1509 to a user.
[0131] In this example, the tube 1508 merges with tube 1509.
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 1510, 1513. Two medications may be
delivered according to two separate programs, protocols,
parameters.
[0132] 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.
[0133] FIGS. 16-18 further illustrate operation of other
embodiments. In FIG. 16, oral diuretic medication is used in
combination with a diuretic infusion pump. Some patients may need
to take doses of diuretics that are higher than what is available
from a portable diuretic infusion pump. In some cases, a larger
diuretic infusion pump may be used. However, some people may not
like the larger size. In an alternate approach, the diuretics
infusion pump may instruct the user to take oral diuretics to
supplement the diuretic infusion. This can keep the size of the
pump smaller. In FIG. 16, the display 1602 of a diuretic infusion
pump 1601 shows instruction to take furosemide 80 mg pill in
addition to diuretic infusion through the diuretic infusion pump.
FIG. 24 shows a protocol that uses oral furosemide pills in
addition to furosemide infusion.
[0134] In FIG. 17, the device provides instructions on diuretic
titration based on a patient's body weight or other conditions or
variables. In this example, the device does not have infusion
capacity. Examples include portable phones and PDAs (personal
digital assistant). Here, the device 1701 has a display 1702 which
shows instructions to increase the dose of furosemide according to
the weight.
[0135] In FIG. 18, the diuretic infusion device has various other
functions that may improve the health of patients. For example, if
body weight increases due to increased body fluid, it helps to
remind patients to control the amount of salt (sodium) that they
take daily. The display 1802 shows instructions to avoid food high
in sodium. 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.
[0136] 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 1802. See FIG. 36. 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 1803 to notify family, help agent, 911 or hospital
for help during emergent situations. These various functions may be
programmed by a healthcare provider.
[0137] 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. 18, a user is instructed to take potassium
chloride (KCL) 20 meq. See also FIG. 54.
[0138] FIGS. 19-35 show additional protocols for diuretic
dispensing. FIG. 19 illustrates an example of oral furosemide dose
titration protocol that may be programmed for the diuretic infusion
pump, weight measurement apparatus or other devices.
[0139] FIG. 20 illustrates an example of a furosemide infusion
algorithm that may be programmed in the diuretic infusion pump or a
remote control device. Bolus infusion is added to the basal rate
infusion when the measured weight exceeds the target or dry weight
by a certain value.
[0140] In FIG. 21, body weight is measured on different days. Body
weight 1 on day 1 is compared with a previously set target weight
(or dry weight). Body weight 2 on day 2 is compared with a set
target weight and weight 1 to determine if weight is decreasing or
increasing. Body weight 3 on day 3 is compared with a set target
weight and weight 2, weight 1 to determine if weight is decreasing
or increasing. Assume that weight 1 is greater than the target or
dry weight. If weight 2 is greater than the target weight, but less
than weight 1, this may indicate that the diuretic infusion based
on weight 1 and the target weight is lowering the body weight. If
weight 2 is greater than both the target weight and weight 1, this
may indicate that the diuretic infusion based on weight 1 may not
be working appropriately and require an increase of diuretic
infusion.
[0141] FIG. 22 illustrates an algorithm that may be programmed in
the diuretic infusion pump. Even if measured body weight is greater
than the previously set target weight or dry weight, different dose
of diuretic infusion may be required depending on whether weight is
increasing or decreasing. If weight 2 is greater than the target
weight, but less than weight 1, dose computation is performed
according to protocol 1 of FIG. 23. However, if weight 2 is greater
than target weight and weight 1, diuretic dose computation is
performed according to protocol 2 of FIG. 23.
[0142] FIG. 24 illustrates another example of diuretic protocol. If
weight 3 measured on day 3 is still greater than weight 2 on day 2
despite increase of furosemide bolus and basal rate infusion, a
higher dose of furosemide may be needed. To avoid rapid consumption
of furosemide in the reservoir or cartridge, a user may be asked to
take a furosemide pill in addition to furosemide infusion. A user
has an option to choose this furosemide protocol 3 or not. If a
user does not want to use this protocol 3, he can choose not to use
this protocol using the menu and keypad on the diuretic pump. If
this protocol 3 is not chosen, furosemide infusion may be adjusted
according to a protocol 1, protocol 2 or protocol 4 to increase the
infusion rate. Protocol 4 is shown in FIG. 25.
[0143] FIG. 26 illustrates another example of a furosemide infusion
protocol. This protocol 5 does not use basal rate infusion of
furosemide. This protocol 5 provides only bolus infusion of
furosemide. This protocol may be useful for people who want to
remove the diuretic infusion pump after bolus infusion.
[0144] FIG. 27 illustrates an example of a block diagram of an
algorithm that may be programmed in the diuretic infusion pump.
FIG. 27 is different from FIG. 22 in that it utilizes different
protocols. Protocols 6 and 7 are shown in FIGS. 28 and 29.
[0145] FIG. 30 illustrates another example. Diuretic infusion pump
3001 has a screen 3002. A user uses a keypad to edit weight
information. The target weight is displayed on the screen. A cursor
is located on the number to the right of the decimal point. In this
FIG. 31, it is located on the digit 5 3003. A user can choose
different number using scrolls 3004, 3005. S button 3006 is pressed
to select a number. The current weight can be manually put into the
diuretic infusion pump in a similar manner.
[0146] In FIG. 31, a furosemide infusion protocol is shown on the
screen 3101 of the diuretic infusion pump 3102. The underlined
numbers can be changed using scroll buttons 3103, 3104. If scroll
button 3103 is pressed, the number increases. If scroll button 3104
is pressed, the number decreases. The cursor is located on
underlined thick number 3107, which is a 3. If scroll button 3103
is pressed once, the 3 changes to 4. If scroll button 3104 is
pressed once, the 3 changes to 2. If button S 3105 is pressed, the
number is selected. If button S is pressed when number 3107 is 3,
the 3 is selected and cursor moves on to next underlined number
3108. If all numbers are selected, button M is pressed to move on
to another menu.
[0147] FIG. 32 shows another algorithm that may be programmed in
the diuretic infusion pump. In this embodiment, there are three
different diuretic dose protocols: a low dose diuretic protocol
(FIG. 33), a moderate dose diuretic protocol (FIG. 34) and a high
dose diuretic protocol (FIG. 35). The low dose protocol may be used
when a low dose diuretic is adequate to maintain the target body
weight. If the body weight continues to increase on the low dose
diuretic protocol, the diuretic infusion pump is programmed to
automatically change the protocol to the moderate dose diuretic
protocol. If the body weight continues to increase on the moderate
dose diuretic protocol, the diuretic infusion pump is programmed to
automatically change the protocol to the high dose diuretic
protocol.
[0148] In the reverse direction, if the body weight decreases below
a target weight on high dose diuretic protocol, the diuretic
infusion pump is programmed to automatically change the protocol to
the moderate dose diuretic protocol. If the body weight decreases
below a target weight on the moderate dose diuretic protocol, the
diuretic infusion pump is programmed to automatically change the
protocol to the low dose diuretic protocol.
[0149] Another protocol is to automatically change the diuretic
dose protocol to a higher dose protocol if the body weight remains
above a target weight for more than a set period of time. For
example, if the body weight remains above a target weight for more
than three days in a row on the low dose diuretic protocol, the
diuretic pump changes the protocol to the moderate dose diuretic
protocol to decrease body weight. Yet another protocol is to
automatically change the diuretic dose protocol to a lower dose
protocol if the body weight remains below a target weight for more
than a set period of time. In another example, if the body weight
remains below a target weight for more than two days in a row on
the high dose diuretic protocol, the diuretic pump is programmed to
automatically change the protocol to the moderate dose diuretic
protocol. In alternative embodiments, there may be more or less
than three different dose diuretic protocols and/or the triggers of
when to switch protocols may also vary. In alternative embodiments,
the diuretic infusion pump may change the drug infusion protocol
only after a user and/or a healthcare provider, such as a physician
or a nurse, approves the change of the drug infusion protocol.
[0150] A healthcare provider may review the data transmitted by the
diuretic infusion pump system over the internet, wireless
communication, a phone, and/or fax. Data including (not limited to)
current weight, previous weight, blood pressure, the dosage of a
drug, the name of the drug in use, condition of the user, the
presence of other symptoms such as chest pain may be delivered to a
healthcare provider. A healthcare provider may be able to program
the diuretic infusion pump remotely via an internet in alternative
embodiment.
[0151] FIG. 36 depicts another embodiment of the present invention
that uses both weight and blood pressure measurements. A blood
pressure cuff 3604 is attached to an arm of a human body 3602. The
blood pressure cuff 3604 can be connected to a blood pressure
measuring device 3605. The blood pressure measuring device 3605 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 3601
can communicate wirelessly or via other means with the blood
pressure measuring device 3605. In alternative embodiments, the
blood pressure measuring device 3605 can communicate wirelessly or
via other means with an electric scale 3603. In alternative
embodiments, a user manually inputs measured blood pressure into a
diuretic infusion device or a remote control device.
[0152] FIG. 37 illustrates another example of a furosemide infusion
protocol. As shown in FIG. 36, 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.
[0153] FIG. 38 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. 38 shows
the diuretic infusion pump infusing enalaprilat as well as
furosemide according to measured blood pressure to maintain target
blood pressure.
[0154] FIG. 39 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.
[0155] FIG. 40 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.
[0156] 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.
[0157] FIG. 41 illustrates another embodiment. A diuretic infusion
device 4101 is attached to a human body 4102. This portable
diuretic infusion device 4101 delivers diuretics from a reservoir
to the human body 4102. The diuretic infusion device 4101 may be
smaller in size compared to other embodiments shown in other
figures. This diuretic infusion device 4101 can be disposable. The
diuretic infusion device 4101 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 4101 can communicate wirelessly or via
other means with a remote control device 4104. The remote control
device 4104 can communicate wirelessly with a weight measurement
device 4103 and a diuretic infusion device 4101 in one embodiment.
The remote control device 4104 may communicate wirelessly with only
the diuretic infusion device 4101, and not with the weight
measurement device 4103 in alternative embodiments.
[0158] FIG. 42 further illustrates the diuretic infusion device
4201. The diuretic infusion device 4201 has a needle 4203 and
cannula 4202. The diuretic infusion device 4201 is connected to a
human body 4211 subcutaneously via a cannula 4202. The diuretic
infusion device 4201 is disposable in some embodiments, but the
reservoir of the diuretic infusion device can alternatively be
refilled via a hole 4205. The remote control device 4204 programs
and controls the diuretic infusion device 4201. The remote control
device 4204 contains a programmable processor, a controller, a
wireless transmitter/receiver, a keypad with order entry buttons
4207, 4208, 4209, 4210 and a display screen 4206, though some
embodiments may contain fewer components or additional components.
Measured body weight can be transmitted wirelessly from a weight
measurement device 4203 to the remote control device 4204, 4204 in
this embodiment. In alternative embodiments, a user manually inputs
measured body weight into the remote control device 4204. A
controller of the remote control device 4204 may be coupled to a
processor and a wireless receiver/transmitter. When weight
information enters the processor of the remote control device 4204,
the processor can compute the dosage of diuretic based on body
weight. The remote control device 4204 wirelessly transmits
commands to the diuretic infusion device 4201. The remote control
device 4204 can control the infusion rate of the diuretic infusion
device 4201 wirelessly or by other means (e.g., wired). A user can
choose and program particular diuretic infusion protocol(s) using
button(s) 4207, 4208, 4209, 4210 on the keypad of the remote
control device 4204. Various drug infusion protocols and methods
shown in other figures (see FIGS. 4, 19-35, 37, 38, 45 and other
figures) may be embedded in the processor of the remote control
device 4204.
[0159] The processor within the remote control device 4204 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 4204 computes the dosage of diuretic based on
various biological parameters using protocols shown in other
figures. For example, FIGS. 54 and 55 show various biological
parameters and factors that may be used in these embodiments in
combination with weight. 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 4204 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
4204 in alternative embodiments.
[0160] FIG. 43 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.
[0161] 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 biological 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. One example is illustrated in
FIG. 44. 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 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.
[0162] 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.
[0163] 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.
[0164] FIG. 45 illustrates another example of a drug infusion
protocol. In one example, the measured weight of a user is 74 kg
and the target weight is set at 70 kg. There is 4 kg difference
between the target weight and measured weight, and the measured
weight is above the target weight. Following the protocol seen in
FIG. 45-a, the basal rate of furosemide infusion increases by 0.05
mg multiplied by 40 (4 kilograms equals 40 times 100 grams), and
0.05 mg multiplied by 40 is equal to 2 mg. The basal rate of
furosemide infusion increases by 2 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 3 mg per hour for 8 hours daily. If the
protocol seen in FIG. 45-b is to be used, the bolus rate of the
furosemide increases by lmg multiplied by 40 (4 kilograms equals 40
times 100 grams) which is 40 mg. If the previously set bolus dose
of furosemide was 20 mg twice a day, the new bolus dose of
furosemide is 60 mg twice a day following the protocol of 45-b. 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).
[0165] FIG. 46 illustrates an embodiment of a diuretic injecting
apparatus. A preferred diuretic injecting apparatus is a pen-type
injecting apparatus. A diuretic pen is a diuretic delivery system.
The diuretic pen 4602 in FIG. 46 contains a diuretic cartridge
4601. The diuretic drug contained in the cartridge 4601 is
delivered to a user 4604 subcutaneously or intramuscularly via an
injection needle 4603. In one embodiment, a replaceable diuretic
cartridge is used. Alternatively, a diuretic pen with a prefilled
diuretic cartridge can be thrown away when the diuretic runs out.
The body of a diuretic pen is generally a cylindrical tube, but can
also take on other shapes. The diuretic pen can also be designed
without the needle. The diuretic cartridge 4601 contains a plunger
4608 which is moved by an injection screw 4606 axially toward the
injection needle 4603 by pressing a knob 4605 or a button 4605. The
diuretic pen has a display 4607, which can show information such as
time, dose of diuretics, battery use, date, previously used drug
dosage, etc. The diuretic pen may contain a memory storage device.
One example of a memory storage device is flash memory. The knob of
the diuretic pen 4605 may be used to inject dose, change time or
date, go to dose memory, adjust dose by pressing or turning the
knob 4605, and so forth. In some embodiments, the dosage of
diuretic can be determined based on the amount of salt and/or water
intake. In alternative embodiments, the diuretic pen is a metered
dose diuretic infusion system. When the knob 4605 is pressed, a
predetermined amount of diuretic is delivered to the user. For
example, if the user presses the knob 4605 once, a diuretic
injection pen releases 2 mg of furosemide. The user can be
instructed to press the knob 4605 once when the user eats food with
low salt and/or water content, to press the knob twice for food
with moderate salt and/or water content, or to press the knob three
times for food with high salt and/or water content.
[0166] FIG. 47 illustrates wireless communication between a
diuretic pen 4701 and a weight measurement device 4702. Measured
weight may be input into the diuretic pen wirelessly or manually. A
user may input weight manually by using button(s), a knob, etc. As
shown in FIG. 48, the diuretic pen 4701 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 weight.
[0167] FIG. 49 illustrates examples of biological parameters that
are measured by various devices and/or sensors. 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.
[0168] FIG. 50 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 5006 which contains medication pills 5004. Some
embodiments of this pen-type apparatus contain drug suspension. For
example, a user may use this pen-type drug dispensing apparatus
5006 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 lmg 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 5007 and a knob 5001. When knob 5001 is
pushed, screw 5003 is moved to push the pills out of the drug
container. Screw 5003 movement is controlled by a processor in some
embodiments, though screw 5003 movement is controlled manually in
other embodiments. The dosage of 14mg 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 5001 and/or buttons on the apparatus. In alternative
embodiments, when knob 5001 is pressed, a predetermined number of
pills are released out of the container 5006. For example, two
tablets of lmg furosemide pill can be released out of the container
when knob 5001 is pressed. The user may be instructed to press the
knob 5001 one time when the user plans to eat food with low salt
and/or water content, to press the knob 5001 twice when a user
plans to eat food with moderate salt and/or water content, or press
the knob 5001 three times when he plans to eat food with high salt
and/water content.
[0169] FIG. 51 illustrates another embodiment of the present
invention. The pen-type apparatus 5101 is wirelessly connected with
a weight measurement apparatus 5107. The weight measured by the
weight measurement apparatus 5107 is wirelessly transmitted to the
pen-type apparatus 5101. The transmitted weight information enters
the processor in the pen-type apparatus 5101, and the processor
computes the dosage of the diuretics based on the weight. The
dosage of the diuretics is displayed on screen 5104. When knob 5105
is pushed, screw 5103 is moved to push the pills out of the drug
container 5106. Screw 5103 movement can be controlled by a
processor or controlled manually.
[0170] FIG. 52 illustrates another embodiment of the invention. In
this embodiment, a disposable external diuretic infusion pump 5201
is attached to the body 5205 of a user. This disposable external
diuretic infusion pump includes a reservoir that contains the
diuretic. This external diuretic infusion pump 5201 can be a
metered dose infusion pump. The external diuretic infusion pump
5201 is set to deliver a predetermined volume of a drug to the
user. When the user pushes a button 5202, a predetermined volume of
the drug is delivered via a cannula 5203 to the user. The tip of
the cannula 5203 is located subcutaneously in a preferred
embodiment. In some embodiments, a reservoir may be refilled
through a hole 5204. 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 lmg of furosemide to the user each
time button 5202 is pressed. The user can be instructed to press
the button 5202 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 5202 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.
[0171] FIG. 53 illustrates another embodiment. It is important to
measure body weight 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. 53, 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.
[0172] FIGS. 54 and 55 show various biologicalal parameters and
factors that may be used with various embodiments, such as that of
FIG. 42. A remote control device may communicate wirelessly or via
other methods with various devices/sensors as shown in FIG. 54. A
remote control device may use various biologicalal parameters shown
in FIG. 55 to compute the dosage of diuretics.
[0173] FIG. 56 illusrates an ambulatory diuretic infusion pump 5601
mounted at a pole 5602. A diuretic contained in a bag 5606 is
infused into a vein of a patient 5604 through intravenous tube
system 5603. The diuretic infusion pump 5601 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 5605 into the diuretic infusion pump
5601 using a keypad. 5607 or using a remote control device. The
weight measured by the scale 5605 can be transmitted wirelessly to
the diuretic infusion pump in another embodiment.
[0174] 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.
[0175] 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.
[0176] 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.
[0177] 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.
[0178] 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.
[0179] 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.
[0180] 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.
[0181] 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.
* * * * *