U.S. patent application number 10/038516 was filed with the patent office on 2003-07-03 for method and apparatus for providing medical treatment therapy based on calculated demand.
Invention is credited to Bui, Tuan.
Application Number | 20030125662 10/038516 |
Document ID | / |
Family ID | 21900408 |
Filed Date | 2003-07-03 |
United States Patent
Application |
20030125662 |
Kind Code |
A1 |
Bui, Tuan |
July 3, 2003 |
Method and apparatus for providing medical treatment therapy based
on calculated demand
Abstract
A medical treatment administration system 10 for delivering a
medical treatment to a patient 18. The system 10 has a medical
device 12, an electronic processor 28 coupled to the medical device
12, and a sensor 16 coupled to the processor 28. The sensor 16
receives one or more signals which it transfers 24 to the processor
28. The signals can be derived from the patient's physiological
condition and/or the environment of the patient. The processor 28
receives the signals and performs a calculation 30 of the signal.
Based on the result of the calculation, the processor 28 regulates
the distribution of medical treatment to the patient 18 over a
period of time.
Inventors: |
Bui, Tuan; (Green Oaks,
IL) |
Correspondence
Address: |
Francis C.M. Kowalik, Esq.
Corporate Counsel, Law Department
BAXTER INTERNATIONAL INC.
One Baxter Parkway, DF2-2E
Deerfield
IL
60015
US
|
Family ID: |
21900408 |
Appl. No.: |
10/038516 |
Filed: |
January 3, 2002 |
Current U.S.
Class: |
604/67 ;
128/DIG.13 |
Current CPC
Class: |
A61M 5/1723
20130101 |
Class at
Publication: |
604/67 ;
128/DIG.013 |
International
Class: |
A61M 031/00 |
Claims
I claim:
1. A medical treatment apparatus for providing medication to a
patient, comprising: a medical device having a supply of medication
and a means for delivering the medication to the patient, a control
algorithm coupled to the medical device, and a sensor coupled to a
patient to receive information from the patient concerning the
physiological condition of the patient, the information being
transferred from the sensor to the control algorithm, wherein the
control algorithm is adapted to process the information to control
the delivery of the medication from the medical device to the
patient based on the information that was processed.
2. The medical treatment apparatus of claim 1, further comprising
an input device for adjusting parameters of the control
algorithm.
3. The medical treatment apparatus of claim 1, further comprising a
sensor that receives information from the environment of the
patient and transfers the information to the control algorithm
which processes the information.
4. A medical apparatus for delivering a treatment to a patient,
comprising: a medical device having a medical treatment and a
controller electrically connected to the medical device, the
controller dynamically processing a signal received from a sensing
device, the controller developing a feedback control based on a
result of processing the signal to determine whether medication
should be delivered from the medical device to the patient and
providing the feedback control to the medical device to control the
delivery of the medical treatment to the patient.
5. The medical apparatus of claim 4, further comprising a control
algorithm electronically connected to the controller, wherein the
control algorithm processes the signal received from the sensing
device, and wherein the control algorithm develops a feedback
control based on the result of processing the signal to determine
whether medication should be delivered from the medical device to
the patient.
6. The medical apparatus of claim 5, wherein the control algorithm
for the controller is downloaded to the controller.
7. The medical apparatus of claim 4, wherein the medical device has
a supply of medication to be delivered to the patient.
8. The medical apparatus of claim 4, wherein the signal is
automatically obtained from a physiological condition of the
patient without intervention from the patient.
9. The medical apparatus of claim 4, wherein the signal is
automatically obtained from a sensor without intervention from the
patient, and wherein the signal relates to a condition of the
environment surrounding the patient.
10. The medical apparatus of claim 4, wherein the controller is a
component of the medical device.
11. The medical apparatus of claim 4, further comprising an input
device coupled to the controller, the input device provided to
allow an authorized user to manipulate the control algorithm.
12. The medical apparatus of claim 11, wherein the input device is
a remote controller located at a second location distinct from a
first location, and wherein the medical device is located at the
first location.
13. The medical apparatus of claim 4, wherein the sensing device
comprises a vital signs monitor coupled to the patient, the vital
signs monitor obtaining a signal from the patient.
14. The medical apparatus of claim 4, wherein the sensing device
comprises an activity sensor coupled to the patient, the activity
sensor obtaining a signal from the patient.
15. The medical apparatus of claim 4, wherein the sensing device
comprises a light sensor coupled to the controller, the light
sensor obtaining a signal based on the ambient light.
16. The medical apparatus of claim 4, wherein the sensing device
comprises an environmental sensor coupled to the controller, the
environmental sensor obtaining a first signal based on an
environmental factor of the environment of the patient and sending
a second signal to the controller.
17. The medical apparatus of claim 4, wherein the controller and
the sensing device are an integral component.
18. The medical apparatus of claim 4, wherein the sensing device is
an input device that receives manual input.
19. The medical apparatus of claim 18, wherein the patient provides
the manual input.
20. A medical treatment administration system for delivering a
medical treatment to a patient, comprising: a medical device that
delivers a medical treatment to a patient, the medical device
having a processor to regulate the distribution of medical
treatment to the patient over a period of time; and, a first sensor
coupled to the processor, the sensor receiving a signal from the
patient concerning the patient's physiological condition and
transmitting the signal to the processor, the processor receiving
the signal from the sensor and processing the signal to regulate
the distribution of medical treatment from the medical device.
21. The medical treatment administration system of claim 20,
wherein the first sensor is an input device that receives manual
input.
22. The medical treatment administration system of claim 21,
wherein the patient provides the manual input.
23. The medical treatment administration system of claim 20,
wherein the physiological condition is selected from the group
consisting of: the patient's heart rate, the patient's body
temperature, the patient's activity, the patient's metabolic
demand, the patient's cellular metabolism, and the patient's
cellular proliferation.
24. The medical treatment administration system of claim 20,
wherein the processor has a control algorithm that processes the
signal.
25. The medical treatment administration system of claim 20,
further comprising an input device for controlling the
processor.
26. The medical treatment administration system of claim 20,
further comprising a second sensor coupled to the processor, second
sensor obtaining a signal based on a condition of the patient's
environment, the second sensor further transmitting the signal to
the processor.
27. The medical treatment administration system of claim 26,
wherein based on the specific medical treatment to be administered
to the patient, the processor requests the signal from one of the
first sensor and second sensor.
28. The medical treatment administration system of claim 26,
wherein based on the specific medical treatment to be administered
to the patient, the processor requests signals from both of the
first sensor and second sensor, and wherein the processor processes
the signals and regulates the distribution of medical treatment
from the medical device based on the cumulative result of the
processed signals.
29. The medical treatment administration system of claim 20,
wherein the sensor receives a plurality of signals from the patient
concerning the patient's physiological condition and transmits the
signals to the processor, and wherein the processor receives the
signals, processes the signals and regulates the distribution of
medical treatment from the medical device based on the cumulative
result of the processed signals.
30. The medical treatment administration system of claim 20,
wherein the sensor includes an activity sensor that monitors the
body temperature of the patient and that develops a signal to send
to the processor, and a vital signs monitor that monitors the
patient's heart rate and that develops a signal to send to the
processor to, and wherein based on the specific medical treatment
to be administered the processor requests the signal from one of
the activity monitor and the vital signs monitor.
31. The medical treatment administration system of claim 24,
further comprising a second medical device that delivers a medical
treatment to the patient, wherein the control algorithm receives
the signal from the second sensor, processes the signal, and
regulates the distribution of medical treatment from the second
medical device to the patient.
32. The medical treatment administration system of claim 31,
wherein the control algorithm for the first medical device is
distinct from the control algorithm for the second medical
device.
33. A medical treatment administration system for delivering a
medical treatment to a patient, comprising: a medical device that
delivers a medical treatment to a patient; an electronic processor
coupled to the medical device; and, a sensor coupled to the
processor, the sensor receiving a signal from the patient's
environment, the sensor further transmitting the signal to the
processor, wherein the processor regulates the distribution of
medical treatment from the medical device to the patient over a
period of time based on a calculation of the signal.
34. A medical apparatus, comprising: a programmable medical device
for administering a medical treatment to a patient, wherein the
programmable medical device has a means for administering the
medical treatment to the patient, wherein the programmable medical
device has a first input device for entering control commands for
the programmable medical device, and wherein the programmable
medical device is disposed at a first location; a controller having
a control algorithm coupled to the programmable medical device, the
controller having an input device for entering control commands for
the controller, the controller receiving a signal relating to the
physiological condition of the patient, the controller further
controlling the medical device in response to a physiological
change in the condition of the patient.
35. The medical apparatus of claim 34, wherein the input device for
the controller is disposed at a second location.
36. The medical apparatus of claim 34, wherein the input device for
controller and the programmable medical device is the same
device.
37. The medical apparatus of claim 34, further comprising a second
programmable medical device for administering a second medical
treatment to a patient, wherein the controller controls both the
first and second programmable medical devices.
38. The medical apparatus of claim 34, further comprising a second
programmable medical device for administering a second medical
treatment to a patient, and a second controller for controlling the
second programmable medical device, wherein the second controller
receives a signal relating to the physiological condition of the
patient.
39. The medical apparatus of claim 34, further comprising a second
programmable medical device for administering a second medical
treatment to a patient, the second programmable medical device
being manipulated based on a signal received relating to the
patient's environment.
40. A method to provide medical treatment for a patient where the
delivery of the medical treatment is triggered by one or more
physiological conditions of the patient, comprising the steps of:
providing a medication treatment device; providing a control
algorithm; providing a sensor; and, utilizing the sensor to measure
a physiological condition of the patient, transferring the measured
condition to the control algorithm and entering the measured
condition in the control algorithm, developing a result, developing
feedback control based on the result from the control algorithm,
and manipulating the medication treatment device based on the
feedback control to deliver treatment to the patient.
41. The method of providing medical treatment to a patient of claim
40, further comprising: providing an input device for the control
algorithm, and manipulating the input device to modify the control
algorithm.
42. The method of providing medical treatment to a patient of claim
40, wherein the medication treatment device is an infusion
pump.
43. A method to provide medical treatment for a patient where the
delivery of the medical treatment is triggered by one or more
environmental conditions, comprising the steps of: providing a
medication treatment device; providing a control algorithm;
providing a sensor; and, utilizing the sensor to measure an
environmental condition of the environment of the patient,
transferring the measured condition to the control algorithm and
entering the measured condition in the control algorithm,
developing a result, developing feedback control based on the
result from the control algorithm, and manipulating the medication
treatment device based on the feedback control to deliver treatment
to the patient.
44. The method of providing medical treatment to a patient of claim
43, further comprising: providing a remote input device for the
control algorithm, and manipulating the input device to modify the
control algorithm.
Description
DESCRIPTION
[0001] 1. Technical Field
[0002] The present invention relates generally to a medical
treatment apparatus for providing a medical treatment to a patient
based on a calculated demand, and more specifically to a medical
treatment administration system for delivering a medical treatment
to a patient that is automatically triggered and controlled by a
patient's physiological and/or environmental conditions.
[0003] 2. Background of the Invention
[0004] For many types of medical treatments, the impact and
ultimate usefulness of the treatment depends on the patient's
tolerability and sensitivity to the treatment. Such measures assist
physicians in accurately and effectively treating patients. To
date, however, most medical treatments are provided to the patient
based on objective measurements, rather than on actual measurements
of the specific subject or environment of the subject.
[0005] For example, typical medical treatment parameters for many
drug therapies are provided based on the generic circadian system.
Under the circadian system it has been know in the medical industry
that typical biological functions of plants and animals reoccur at
approximately 24-hour intervals. In humans, the body's clock is
located in the suprachiasmatic nucleus (SCN), a distinct group of
cells found within the hypothalamus. The SCN controls or
coordinates the circadian rhythm in the human body. Typically, a
human's circadian rhythm is calibrated by the alternation of light
through the eyes and darkness via melatonin secretion by the pineal
gland.
[0006] Furthermore, the cellular metabolism and proliferation in
normal human tissues display similar rhythms, and thus have
predictable amplitudes and times of peak and trough. Such rhythms
influence drug pharmacology, tolerability, and ultimate usefulness.
For example, it has been thought that the circadian rhythm
influences the uses and effects of anti-cancer medication,
including tolerability and anti-tumor efficacy in cancer treatment.
Therefore, in chronopharmacologic intervention, anti-cancer drugs
are delivered according to a standard circadian rhythm, especially
with chemotherapy. For example, Floxuridine delivery is typically
given in four doses, each dose dependent on the time of the
day:
[0007] 14% of dose between 9 am and 3 pm;
[0008] 68% of dose between 3 pm and 9 pm;
[0009] 14% of dose between 9 pm and 3 am; and,
[0010] 4% of dose between 3 am and 9 am.
[0011] Generally, the time at which the medication is delivered is
selected by the physician to objectively coincide with changes in
the patient's metabolism. However, the circadian rhythm is merely
an estimate of the changes in the patient's metabolism, and is not
based on the actual patient's metabolism. Thus, whether the
medication delivery actually coincides with the patient's actual
metabolism is neither evaluated nor determined.
[0012] Additionally, different medical treatments have different
optimum dosing time-profiles. For example, different anti-tumor
drugs are typically dosed at different times: Epirubicin and
Daunorubicin are typically dosed at 2 hours after light onset;
Cyclophasphamide is typically dosed at 12 hours after light onset;
Cisplatin is typically dosed at 15 hours after light onset; and,
Vinblastine is typically dosed at 18 hours after light onset. As
can be seen, different drugs have different mechanisms of
action.
[0013] Other factors, however, may also affect proper medical
treatment. For example, the minimum sensitivity of normal tissue is
thought to be related to the enzyme levels that affect drug
metabolism (e.g., glutathione). An overall driver of these
variables is thought to be the rest-activity cycle of the patient.
Because of this effect, it is known that laboratory rat studies
should be conducted with the animal subjected to a 12 hour light,
and 12 hour dark cycle.
[0014] Nevertheless, it is known that different patients, and with
regard to cancer treatment, even different tumors, are not all on
the same circadian cycle. Thus, there are at least two aspects one
needs to optimize during circadian therapy: (1) the peak
sensitivity of the tumor(s); and, (2) the minimum sensitivity of
the normal tissues.
[0015] Standard chronopharmacologic intervention takes advantage of
the circadian rhythm in drug tolerability by controlling the timing
and dosing. Thus, it can reduce the effect of toxicity and improve
the quality of life for the patient. Furthermore, with many drugs,
including chemotherapy drugs, by administering a higher maximum
tolerated dose at the least toxic circadian time, an improvement in
survival may be derived. However, as explained above, there are
numerous flaws with providing medical treatments following the
standard circadian system.
[0016] Thus, a method and a means for subjectively determining,
triggering and controlling the delivery of medical treatments for a
specific patient is highly desirable.
SUMMARY OF THE INVENTION
[0017] The method and apparatus for providing medical treatment
therapy of the present invention is based on actual data to
calculate a strategic control. Generally, the system of the present
invention comprises a medical device, a control algorithm coupled
to the medical device, and a sensing device.
[0018] According to one aspect of the present invention, the
sensing device automatically receives a signal and transfers the
signal to the control algorithm. The control algorithm processes
the signal received from the sensing device to determine whether
the medical treatment should be delivered to the patient. Based on
the result of the processed signal, the control algorithm develops
a feedback control to control the delivery of the medical treatment
to the patient.
[0019] According to another aspect of the present invention, a
medical apparatus is provided for delivering a treatment to a
patient. The medical apparatus comprises a medical device having a
medical treatment, and a controller electrically connected to the
medical device. The controller has a control algorithm stored
therein that dynamically processes a signal received from a sensing
device. The control algorithm develops a feedback control based on
a result of processing the signal to determine whether medication
should be delivered from the medical device to the patient and
provides the feedback control to the medical device to control the
delivery of the medical treatment to the patient.
[0020] According to another aspect of the present invention, the
sensor is coupled to a patient to receive information from the
patient concerning the physiological condition of the patient. The
information received from the sensor is transferred to the control
algorithm, and the information is processed to control the delivery
of the medication from the medical device to the patient.
[0021] According to another aspect of the present invention, the
signal concerning the patient's physiological condition is selected
from the group consisting of: the patient's heart rate, the
patient's body temperature, the patient's activity, the patient's
metabolic demand, the patient's cellular metabolism, and the
patient's proliferation.
[0022] According to another aspect of the present invention, the
sensor receives a signal from the patient's environment. The sensor
transmits the signal to the processor, wherein the processor
regulates the distribution of medical treatment from the medical
device to the patient over a period of time based on a calculation
of the signal.
[0023] According to another aspect of the present invention, the
medical treatment administration system for delivering a medical
treatment to a patient comprises a medical device and a first
sensor. The medical device has a processor that regulates the
distribution of medical treatment to the patient over a period of
time based on a signal from the sensor. The first sensor, which is
coupled to the processor, receives a signal from the patient
concerning the patient's physiological condition and transmits the
signal to the processor. The processor then processes the received
signal to regulate the distribution of medical treatment from the
medical device.
[0024] According to another aspect of the present invention, the
medical treatment administration system further comprises a second
sensor coupled to the processor. The second sensor obtains a signal
based on a condition of the patient's environment and transmits the
signal to the processor. Depending on the specific medical
treatment to be administered to the patient, the processor requests
the signal from one of the first sensor and second sensor.
[0025] According to another aspect of the present invention, the
processor requests signals from both of the first sensor and second
sensor, and the processor processes the signals and regulates the
distribution of medical treatment from the medical device based on
the cumulative result of the processed signals.
[0026] According to another aspect of the present invention, the
sensor receives a plurality of signals from the patient concerning
the patient's physiological condition and transmits the signals to
the processor. The processor receives the signals, processes the
signals and regulates the distribution of medical treatment from
the medical device based on the cumulative result of the processed
signals.
[0027] According to another aspect of the present invention, the
medical treatment administration system further comprises a second
medical device that delivers a medical treatment to the patient.
The processor receives a signal from the second sensor, processes
the second signal, and regulates the distribution of medical
treatment from the second medical device to the patient.
[0028] According to another aspect of the present invention, the
medical apparatus, comprises a programmable medical device for
administering a medical treatment to a patient, and a controller.
The programmable medical device has a first input device for
entering control commands for the programmable medical device, and
the controller has a second input device for entering control
commands for the controller. The input devices may be located in
the same location, or one or more input devices may be located at a
remote location, which may or may not be the same remote
location.
[0029] According to another aspect of the present invention, the
sensing device of the present invention comprises a vital signs
monitor coupled to the patient. The vital signs monitor obtains a
first signal from the patient and transfers a second signal to the
controller.
[0030] According to another aspect of the present invention, the
sensing device comprises an activity sensor coupled to the patient.
The activity sensor obtains a first signal from the patient and
transfers a second signal to the controller.
[0031] According to another aspect of the present invention, the
sensing device obtains a signal based on the cellular metabolism of
the patient.
[0032] According to another aspect of the present invention, the
sensing device obtains a signal based on the cellular proliferation
in the patient.
[0033] According to another aspect of the present invention, the
sensing device comprises a light sensor coupled to the controller,
the light sensor obtaining a first signal based on the ambient
light and sending a second signal to the controller.
[0034] According to another aspect of the present invention, the
sensing device and the controller having the control algorithm are
an integral component.
[0035] According to yet another aspect of the present invention, a
method to provide medical treatment for a patient is provided. The
delivery of the medical treatment may be triggered by one or more
physiological or environmental conditions of the patient.
[0036] Other features and advantages of the invention will be
apparent from the following specification taken in conjunction with
the following drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0037] To understand the present invention, it will now be
described by way of example, with reference to the accompanying
drawings in which:
[0038] FIG. 1 is a block diagram of a medical treatment
administration system of the present invention;
[0039] FIG. 2 is a block diagram of a variation of the medical
treatment administration system of FIG. 1, including remote
controlling;
[0040] FIG. 3 is a block diagram of another variation of the
medical treatment administration system of FIG. 1, including where
the controller is a component of the medical device;
[0041] FIG. 4 is a block diagram of another variation of the
medical treatment administration system of FIG. 1, including a
variety of sensing devices;
[0042] FIG. 5 is a block diagram of another variation of the
medical treatment administration system of FIG. 1, including a
variety of sensing devices;
[0043] FIG. 6 is a block diagram of another variation of the
medical treatment administration system of FIG. 1, including where
the controller and the sensing device are an integral
component;
[0044] FIG. 7 is a block diagram of another variation of the
medical treatment administration system of FIG. 1, including a
plurality of medical treatment devices;
[0045] FIG. 8 is a block diagram of another variation of the
medical treatment administration system of FIG. 7, including a
processor for a plurality of medical treatment devices;
[0046] FIG. 9 is a front elevation view of one embodiment of an
infusion pump utilized with the present invention; and,
[0047] FIG. 10 is a block diagram of one type of a control
algorithm of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0048] While this invention is susceptible of embodiments in many
different forms, there is shown in the drawings and will herein be
described in detail preferred embodiments of the invention with the
understanding that the present disclosure is to be considered as an
exemplification of the principles of the invention and is not
intended to limit the broad aspect of the invention to the
embodiment illustrated.
[0049] Referring now in detail to the Figures, there is shown a
medical treatment administration system 10 utilizing a medical
treatment delivery control to distribute the medical treatment
based on the condition of the specific patient and/or a change in
the environment of the specific patient. As shown in FIG. 1, one
embodiment of the medical treatment administration system 10
includes a medical device 12, a control algorithm 26 coupled to the
medical device 12, and a sensor 16 coupled to the patient 18. The
medical device 12 may be one of a variety of devices, including,
but not limited to infusion pumps, ventilators, insulin delivery
devices, and anesthesia delivery devices, however, one of ordinary
skill in the art would understand that other medical devices could
be utilized without departing from the scope of the invention.
Additionally, the medical device 12 may be programmable.
[0050] In one embodiment, an infusion pump 20, illustrated in FIG.
9, is utilized as the medical device 12 for administering a liquid
medicant to the patient 18. Typically, the medical device 12 has a
supply of medication (not shown) and a means for delivering the
medication (not shown) to the patient 18. With the infusion pump
20, the supply of medication is typically a liquid medicant
retained in a syringe or IV-type bag. Additionally, with an
infusion pump 20 the means for delivering the medication includes a
liquid injection device, often a hollow needle or catheter, adapted
to be connected to the patient, a conduit or tubing connected to
the liquid injection device, a pumping mechanism for pumping the
liquid medicant through the conduit and into the patient via the
liquid injection device, and a controller for controlling the
pumping mechanism. However, when other types of medical devices are
utilized, the medical treatment and the means for delivering the
treatment will likely vary to be in accord with the specific
medical device. For example, a ventilator provides oxygen to the
patient, an insulin delivery mechanism delivers insulin to the
patient, and an anesthesia device provides anesthesia gas or
anesthesia medication to the patient, is each with the appropriate
delivery means.
[0051] In the embodiment illustrated in FIG. 1, the sensor 16 is
coupled to the patient 18 and receives information from the patient
18 concerning the physiological condition of the patient 18. As is
understood by one of ordinary skill in the art, such physiological
conditions may include, but are not limited to, the patient's heart
rate, the patient's body temperature, the patient's blood pressure,
the patient's activity level, the patient's cellular metabolism,
the patient's cellular proliferation, the patient's metabolic
demand, the patient's food intake, and the patient's SpO.sub.2
level, etc. Such factors, as well as other factors known by one of
ordinary skill in the art, are understood to be triggering events
for the distribution of medical treatment, and especially drug
therapy, to individuals in the treatment of medical conditions.
Additionally, the sensing device may comprise an input device for
receiving a manual input. The manual input may be provided by a
health care provider or the patient. One example of the patient
providing input for the sensing device is where the medical device
12 is a insulin delivery mechanism. As such, the patient may
provide input to the sensor indicating the type of food consumed by
the patient.
[0052] In one embodiment, multiple sensors 16 are comprised in a
portable multiparametric physiological monitor (not shown) for
continuous monitoring of certain physical parameters of the
patient. The monitor has sensors 16, including: EKG electrodes, a
chest expansion sensor, an accelerometer, a chest microphone, a
barometric pressure sensor, a body temperature sensor and an
ambient temperature sensor. Each of the sensors provides an output
signal to an analog-to-digital converter (ADC).
[0053] In such an embodiment, the sensors 16 may be provided in a
body strap (not shown) which, could comprise a chest strap upon
which are distributed the various sensors and supporting
electronics. (It will be recognized by those skilled in the art
that a multiparametric monitoring device may also be mounted by a
strap about a part of the body other than the chest). The chest
strap is adapted to fit around the torso of the patient 18.
[0054] The variety of parametric sensors 16 are located on the
strap as most appropriate for the parameter (or parameters) which
it detects. Each of the sensors 16 provides an electrical input to
analog circuitry which filters and amplifies the sensor signals, as
known in the art of signal processing, and outputs them to an
analog-to-digital converter, which may be part of controller
hardware. The sensors in the strap may be as follows: a pectoralis
temperature sensor which senses the temperature of the surface of
the patient's chest; barometric pressure sensor which senses the
ambient barometric pressure of the patient's environment; chest
expansion (ventilation) sensor which detects the tension on the
chest strap as an indication of the expansion and contraction of
the patient's chest; accelerometer which detects movement and
inclination of the patient's body; ambient temperature sensor which
senses the ambient temperature of the patient's environment;
microphone which detects sounds from within the patient's torso;
underarm temperature sensor which senses the temperature of the
side of the patient's torso underneath the arm; and, EKG electrodes
which detect electrical signals caused by action of the heart
muscle. The EKG electrodes are used in combination with ground, or
reference, electrodes, and are placed in contact with the skin of
the patient's chest to detect electrical signals generated by the
pumping action of the patient's heart muscle. The EKG
(electrocardiogram) is an indication of the patient's heart
activity, as is well known in the a field of medicine.
[0055] Also as shown in FIG. 1, sensor 17 may be provided in
addition to, or in substitution of, sensor 16. Sensor 17 obtains
information concerning the environment of the patient 18.
Typically, the sensors 16,17 automatically obtain the signal
concerning the physiological condition of the patient and/or the
condition of the environment, respectively, without intervention
from the patient 18. Depending on the information required by the
control algorithm 26, multiple sensors 16,17 may be utilized in
series or in parallel (FIGS. 1, 4, 7 and 8).
[0056] The sensors 16,17 may be any device that is capable of
receiving a signal (i.e., information), whether from an individual
16, such as a signal concerning the individuals heart rate, body
temperature, blood pressure, activity level, cellular metabolism,
cellular proliferation, metabolic demand, SpO.sub.2 level, etc., or
based on an environmental condition 17, such as the ambient
temperature, ambient light condition, etc. As shown in FIGS. 4 and
5, such sensors 16,17 may include, but are not limited to, vital
signs monitors, blood pressure monitors, light sensors,
environmental sensors and activity sensors. Additionally, as shown
in FIG. 6, rather than being a separate component, the sensors
16,17 may be integral with the controller 28.
[0057] The signal received from the sensor 16,17 is electrically
transferred 24 to a control algorithm 26. As shown in FIGS. 2, 3
and 6, the control algorithm 26 may be a part of the controller 28
(also referred to as a processor). Additionally, as shown in FIG.
3, the controller 28 may be a component of the medical device 12.
Depending on the specific medical treatment to be administered to
the patient 18, the control algorithm 26 may request signals from
one or more sensors 16,17. While it is understood that the
rest-activity or metabolism cycle of a patient can be determined
invasively by measuring various elements including blood cell
counts, plasma or serum concentration of cortisol, liver enzymes,
and creatine, other methods may also be available. For example, the
rest-activity or metabolism cycle of a patient can also be measured
non-invasively by the vital sign or activity of the patient.
Additionally, it has been found that the body temperature of a
patient drops during the night, and that a patient's heart rate
drops when the patient is at rest. Accordingly, such signals are
obtained by the sensors 16,17, and such information is transferred
24 to the control algorithm 26 for processing.
[0058] It is understood that the control algorithm 26 will likely
be different for each different medical treatment, and further it
is also understood that the control algorithm 26 may be different
for different patients, even for the same medical treatment. One
example of a control algorithm 26 is shown in FIG. 10. As shown in
FIG. 10, the control algorithm 26 is utilized to control the
delivery of medication to a patient as a function of the patient's
18 heart rate. In this embodiment, the control algorithm 26
receives a signal of the patient's heart rate from one of the
sensors 16. The control algorithm 26 processes the signal 30 by
comparing the signal with the maximum heart rate. If the heart rate
signal is less than the maximum heart rate signal the control
algorithm develops a feed back control 32 to reduce the rate of
infusion of the infusion pump 12 by 2%. If the heart rate signal is
not less than the maximum heart rate signal the control algorithm
further determines if the infusion therapy has been completed. If
the infusion therapy has not been completed, feedback control 32 is
provided to continue infusion. Additional processing 30 of the
heart rate signal is subsequently continued. If the infusion
therapy has been completed, feedback control 32 is provided to stop
the infusion pump 12.
[0059] After the control algorithm 26 receives the transferred
signal 24 it processes 30 the signal through the control algorithm
26 and the resultant feedback control 32 is developed. If multiple
signals are requested and received from a plurality of sensors
16,17, each required signal is processed 30 through the control
algorithm 26 as programmed, and a resultant feedback control 32 is
developed. The feedback control 32 operates as a control signal for
the medical device 12 to control or regulate delivery of the
medical treatment to the patient 18.
[0060] This is accomplished by transferring 34 the feedback control
32 that was developed by the control algorithm 26 to the medical
device 12. The feedback control 32 provides the commands for
operation of the medical device 12. The feedback control 32
typically provides one of two signals or commands to the medical
device 12: deliver 36 medical treatment to the patient 18 or do not
deliver 38 medical treatment to the patient. If the feedback
control 32 provides a signal to deliver 36 the medical treatment it
may also provide a signal to the medical device 12 indicating the
amount and rate of treatment to provide to the patient 18. Such a
signal may include increasing or decreasing the rate of medication
delivery.
[0061] As shown in FIG. 7, multiple medical devices 12a, 12b may be
utilized to deliver 36 medical treatments to the patient 18. The
specific medical treatments may be the same, and may merely be
dosed differently, or each medical device 12a,12b may deliver 36 a
different medical treatment to the patient 18. Further, as also
shown in FIG. 7, separate control algorithms 26a,26b may be
utilized for each medical device 12a,12b, respectively. The
embodiment of FIG. 7, utilizes two distinct control algorithms
26a,26b, and numerous sensors 16a, 16b and 17. Sensors 16a, 17
transfer 24 signals to control algorithm 26a, which, depending on
the treatment to be delivered 36 to the patient 18, may process 30
the signals from one or both of the sensors 16a,17 to develop a
resultant feedback control 32a. Sensor 16b transfers 24 a signal to
control algorithm 26b which likewise processes 30 the signal and
develops a resultant feedback control 32b. Feedback control 32a is
sent to the first medical device 12a to control the delivery 36a of
medical treatment to the patient 18, while feedback control 32b is
sent to the second medical device 12b to control the delivery 36b
of medical treatment to the same patient 18.
[0062] Conversely, as shown in FIG. 8, one control algorithm 26 may
control multiple medical devices 12a,12b. In this embodiment, one
control algorithm 26 is utilized with a plurality of sensors 16a,
16b and 17. Sensors 16a, 16b and 17 transfer 24 signals to the
control algorithm 26, which, depending on the treatment to be
delivered 36 to the patient 18, may process 30 the signals from one
or more of the sensors 16a, 16b and 17 to develop one or more
resultant feedback controls 32a,32b. Feedback control 32a is sent
to the first medical device 12a to control the delivery 36a of
medical treatment to the patient 18, while feedback control 32b is
sent to the second medical device 12b to control the delivery 36b
of medical treatment to the same patient 18. Accordingly, in this
embodiment the control algorithm 26 for the first medical device
12a is the same control algorithm 26 as for the second medical
device 12b.
[0063] Because the medical treatment apparatus 10 may be utilized
with different treatment therapies, the control algorithm 26 is
generally modified or changed for each different treatment therapy.
Thus, as shown in FIGS. 1 and 2, an input device 42 is generally
provided to adjust and set the control parameters 44 of the control
algorithm 26. The input device 42 may be coupled to the controller
28 or directly to the control algorithm 26. While the control
algorithm 26 may be manually input, it may also be dynamically
downloaded as from a database or network.
[0064] Further, as shown in FIG. 1, the medical device 12 may also
have an input device 48 therefor. The input device 48 for the
medical device 12 allows a user, typically an authorized clinician
to enter control commands 50 to adjust or set control parameters
for the medical device 12. In an alternate embodiment, the input
device for the medical device 12 is the same as the input device
for the controller/control algorithm.
[0065] As shown in FIG. 2, a remote controller 46 (i.e., a remote
input device) may be provided for remotely adjusting or setting the
control parameters of the control algorithm 26 and/or controller
28. U.S. Pat. No. 5,885,245, assigned to the assignee of the
present invention, discloses a remote controller, among other
things, and is expressly incorporated herein by reference, and made
a part hereof. The remote controller 46 is disposed at a room
location (i.e. a second location) remote from the room location at
which the medical device 12 is located (i.e., a first location).
The remote controller 46 could be disposed in a different room of
the same building in which the medical device 12 is disposed, or in
a different building than the one in which the medical device 12 is
disposed. The remote controller 46 is connected to a conventional
voice/data modem 52 via a data link 54, and the modem 52 is also
connected to a telephone 56 via a voice link 58. The medical device
12 is connected to a conventional voice/data modem 60 via a data
link 62, and the modem 60 is connected to a telephone 64 via a
voice link 66. The two modems 52, 60 are interconnected to
bidirectional voice and data communication via a communication link
68, which could be a telephone line, for example. Additionally, the
remote controller 46 may communicate with the control algorithm 26
via an internet, an intranet and a wireless network. Furthermore,
the remote controller 26 may be a server.
[0066] While the specific embodiments have been illustrated and
described, numerous modifications come to mind without
significantly departing from the spirit of the invention, and the
scope of protection is only limited by the scope of the
accompanying Claims.
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