Note: Descriptions are shown in the official language in which they were submitted.
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METHOD AND SYSTEM FOR IMPROVING VASCULAR SYSTEMS
BY BIOFEEDBACK AND NETWORKING
PRIORITY CLAIM; CROSS-REFERENCE TO RELATED APPLICATIONS
The present application claims domestic priority, under 35 U.S.C. ~119(e),
from
prior provisional application number 60/295,768, filed June 5, 2001, the
entire contents of
which are hereby incorporated by reference as if fully set forth herein.
FIELD OF THE JNVENTION
The present invention generally relates to medical and physiological
information
processing systems. The invention relates more specifically to a method and
system for
improving vascular systems in humans using biofeedback and network data
communication.
BACKGROUND OF THE INVENTION
The approaches described in this section could be pursued, but are not
necessarily
approaches that have been previously conceived or pursued. Therefore, unless
otherwise
indicated herein, the approaches described in this section are not~prior art
to the claims in
this application and are not admitted to be prior art by inclusion in this
section.
Vasculax disease occurs widely in humans and is a significant cause of
premature
death in many human populations. In general, vascular disease is characterized
by the
accumulation of fatty deposits on the walls°of the arteries, causing
the arterial walls to
thicken and become less elastic. As a result, the flow of blood to all cells
and tissues of
the body is reduced. Heart disease is an example of vascular disease. Coronary
artery
disease is the leading cause of death in the adult population of the United
States.
The medical community recognizes that the incidence of vascular disease in
many
populations can be reduced significantly. One way to reduce the incidence of
vascular
disease is to improve identification of individuals' risks for hypertension,
elevated
cholesterol, obesity, diabetes, smoking, inactivity and aging. Vascular
disease is strongly
associated with these conditions. As one commentator has observed, "[t]ools
that would
quantify all cardiovascular risks for use with hypertension would be a welcome
and even
more powerful aid than the additive technique we now have." See S. Sheps,
"Treating
Hypertension," Hippocrates, v. 13 no. 11 (Dec. 1999).
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Presently, medical evaluation and treatment of vascular disease involves using
vascular studies to determine whether an individual presenting symptoms are
due to
vascular disease. Such studies may involve use of procedures and machines such
as
magnetic resonance imaging, angiograms, thallium scans, and others, many of
which are
expensive to administer. As a result, they are generally used only in patients
who already
exhibit other symptoms of vascular disease, or who have other associated
health
problems. Recently the American Heart Association issued a Scientific
Statement (see
Circulation, 2000;101:e3 and Circulation, 2000;101 e163) suggesting possible
evaluation
interventions using ankle brachial blood pressure, ultrasound and volume
studies and
scans. However, these methods are not widely used at the clinical level for
evaluation of
vascular disease.
Currently, Doppler vascular studies are performed to evaluate peripheral
artery
disease occurring in the arms or legs. Further, the AHA Scientific Statement
identified
above references prior work in using duplex vascular studies of the carotid
arteries to
determine and correlate anatomical changes of the coronary arteries. However,
Doppler
vascular studies (functional studies) of the peripheral circulatory system are
not presently
used to evaluate risk of cardiovascular disease, and are not used to evaluate
risk in
asymptomatic individuals.
Even when vascular disease is successfully identified in a patient, the
current
standard of care has drawbacks. For example, drugs of the class known as beta
blockers
are coimnonly prescribed, but these often cause significant complications,
including
depression of the heart, emotional depression, impotence, effects on diabetic
control,
effects on exercise, etc.
Biofeedback techniques are known for treating certain kinds of health problems
by training people to respond to signals from their own bodies. See, e.g., B.
Runck,
"What is Biofeedback?," National Institute of Mental Health, Dept. of Health &
Human
Services Pub. No. (ADM) 83-1273. However, biofeedback is not presently applied
to the
treatment of vascular disease.
Still another problem associated with treatment of vascular disease is that
health
care providers lack the ability to receive and evaluate data about the then-
current vascular
health of an individual outside the clinical setting. Certain techniques for
obtaining
snapshots of data are known. For example, a Holter monitor may be used to
gather an
electrocardiogram from an individual during that person's normal activities
away from a
clinical setting. Conventional EKG electrodes are attached to the individual
at a clinic,
and the electrodes are coupled to a portable data collection device that
measures and
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stores EI~G data over a specified period of time, typically 24 hours. After
the data
collection period, the individual returns to the clinic, where the data is
downloaded into a
computer for analysis, and the monitor is removed. However, Holter monitors
are not
reliable, and rnay indicate cardiac disease only when it is severe. The same
disadvantages
are known with respect to treadmill stress tests.
Past approaches to addressing similar problems include certain online
businesses.
For example, "Healtheheart.com" offers online monitoring of cardiovascular
diseases and
online storage of clinical records, but is offered only to physicians and
essentially
monitors only disease conditions. "Stayhealthy.com" provides certain online
tools for
health evaluation, but functions only as an information service. "Wellmed.com"
offers
online services for personal health including personalized records and clinic
files.
"Lifemasters.com" provides online monitoring of patients with chronic
diseases.
"Dynapulse.com" provides blood pressure monitoring devices to measure cardiac
function based on blood pressure readings that are uploaded over the Internet.
An analysis
center interprets data and provides reports. None of these approaches,
however, uses
biofeedback interactions, and none uses Doppler vascular data obtained from
the
peripheral vascular system as a global measurement tool for evaluating
vascular disease.
Based on the foregoing, there is a need for a way for improved systems and
methods for treatment of vascular disease.
There is also a need for a way for a healthcare provider to collect vascular
data
from an individual who is engaging in normal daily activities, away from a
clinic, over a
long period of time, such as months or years.
There is also a need for a way for a patient and a healthcare provider to
concurrently have access to such vascular data.
Further, it would be benef cial to have ways for patients to engage in self
directed
follow-up treatment of vascular disease through biofeedback techniques, after
the initial
physician evaluation.
SUMMARY OF THE INVENTION
The foregoing needs, and other needs and objects that will become apparent for
the following description, are aclueved in the present invention, which
comprises, in one
aspect, a method for improving vascular systems in humans using biofeedback
and
network data communication.
In one aspect, the invention provides a method for improving diagnosis,
prevention, reduction and prognosis of vascular disease by evaluating the
vascular system
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of an individual. Embodiments may involve measuring risk of vascular disease
using
blood pressure measurements, pulse measurements, and Doppler vascular
monitoring
from the peripheral vascular system, in association with biofeedback
mechanisms and
data communication over a network. Thus, embodiments provide methods and means
for
preventing, reducing, diagnosing, and determining a prognosis for vascular
disease.
In other embodiments, methods for treating vascular disease in humans and
generating data representing treatment plans are disclosed. A first set of
clinical vascular
health data from a healthcaxe provider and representing a vascular health
condition of a
patient is received at a data center server that is communicatively coupled to
a public data
network. One or more vascular disease analysis algorithms are applied to the
first set of
vascular health data, to result in creating and storing an initial treatment
plan for the
patient.
A second set of vascular health data is received, after initial physician
evaluation,
from a monitoring device that is associated with the patient and that is
communicatively
coupled to the data network. The second set of vascular health data include
data obtained
using a Doppler vascular monitor that is attached to an external location
proximate to the
peripheral vascular system of the patient. One or more vascular analysis
algorithms are
applied to result in creating one or more supplementary treatment plans for
the patient. At
least one of the treatment plans includes a biofeedback interaction. The
treatment plans
are provided to the patient over the data network. The foregoing steps are
iteratively
repeated one or more times as determined by the physician and patient,
resulting in
improved vascular health.
Embodiments are applicable to treatment of individuals who are asymptomatic or
symptomatic with respect to vascular disease, hypertension, elevated
cholesterol, and
diabetes, and are useful in achieving stress reduction, addressing weight
problems,
smoking cessation, and improving personal lifestyle choices and habits.
In other aspects, the invention encompasses a computer apparatus and a
computer
readable medium configure to carry out the foregoing steps.
BRIEF DESCRIPTION OF THE DRAWINGS
The present invention is illustrated by way of example, and not by way of
limitation, in the figures of the accompanying drawings and in which like
reference
numerals refer to similar elements and in which:
FIG. 1 is a block diagram of a system fox improving vascular systems in
humans,
according to one embodiment;
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FIG. 2 is a flow diagram that provides an overview of a method of improving
vascular function in humans, using the system of FIG. 1, according to one
embodiment;
FIG. 3 is a block diagram of a vascular monitoring device, according to one
embodiment;
FTG. 4 is a block diagram of a vascular data and treatment application,
according
to one embodiment;
FTG. 5 is a block diagram of an architecture of a vascular data center server,
according to one embodiment;
FIG. 6A is a flow diagram that illustrates one embodiment of a network
biofeedback vascular disease treatment method;
FIG. 6B is a flow diagram that illustrates a second embodiment of a network
biofeedback vascular disease treatment method involving both a user or patient
and a
healthcare provider;
FIG. 6C is a flow diagram that illustrates a further embodiment of a network
biofeedback vascular disease treatment method;
FIG. 7 is a flow diagram of a first biofeedback interaction that provides a
progressive relaxation technique;
FIG. 8 is a flow diagram of a second biofeedback interaction that provides a
nutrition interaction;
FIG. 9 is a flow diagram of a third biofeedback interaction that provides an
exercise interaction;
FIG. 10A is a flow diagram of a fourth biofeedback interaction that addresses
effects of cardiovascular medications;
FIG. 1 OB is a flow diagram of a fifth biofeedback interaction that relates to
physician review of data results; and
FIG. 11 is a block diagram that illustrates a computer system upon which an
embodiment may be implemented.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
A method and apparatus for improving treahnent of vascular disease in humans
using biofeedback and network data communication is described. In the
following
description, for the purposes of explanation, numerous specific details are
set forth in
order to provide a thorough understanding of the present invention. It will be
apparent,
however, to one skilled in the art that the present invention may be practiced
without
these specific details. In other instances, well-known structures and devices
are shown in
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block diagram form in order to avoid unnecessarily obscuring the present
invention.
Embodiments are described herein according to the following outline:
1.0 Structural and Functional Overview
Structural Details of One Embodiment
Vascular Data Measurement Device
Vascular Data Client Application
Data Center Server Architecture
Functional Details of One Embodiment
Network Biofeedback Vascular Disease Treatment Method
Interaction with User Alone (After Initial Physician Evaluation)
Interaction with User and Healthcare Provider
Institutional, University and Research Uses
Examples of Biofeedback Mechanisms
4.0 Implementation Mechanisms-Hardware Overview
5.0 Extensions and Alternatives
1.0 STRUCTURAL AND FUNCTIONAL OVERVIEW
In one aspect, the invention provides a method for improving diagnosis,
prevention, reduction and prognosis of vascular disease by evaluating the
vascular system
of an individual. Embodiments may involve measuring risk of vascular disease
using
blood pressure measurements, pulse measurements, and Doppler vascular testing,
in
association with biofeedback mechanisms and data communication over a network.
Thus,
embodiments provide methods and means for preventing, reducing, diagnosing,
and
determining a prognosis for vascular disease.
FIG. 1 is a block diagram of a system for improving vascular systems in
humans,
according to one embodiment. A user or patient 10 has a monitoring device 12
that is
communicatively coupled to a first client system 14A. The client system 14A
may be, for
example, a personal computer, personal digital assistant (PDA), wireless
computing
device, or worlcstation, etc., that is interfaced to monitoring device 12
using an
appropriate hardware interface and software interface. Throughout this
description, the
terms "patient" and "user" are used interchangeably to refer to any individual
who uses
the systems and methods described herein, regardless of medical or health
condition.
The monitoring device 12 is an electronic unit for monitoring and generating
data
relating to one or more physiological characteristics of patient 10. In one
embodiment,
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monitoring device includes a pulse monitor, blood pressure monitor, pulse
oxymeter, and
vascular Doppler monitor. All such monitors may be contained within a single
unit that is
handheld or otherwise conveniently secured to the body. Alternatively, a
plurality of
separate conventional monitoring devices including a vascular Doppler monitor
may be
used, which are collectively represented by element 12 in the drawing figures.
In still
other embodiments, different monitoring devices are used; for example,
monitoring
device 12 may comprise a glucometer for monitoring blood glucose and diabetes
using
the same techniques described herein with respect to vascular disease. In one
specific
embodiment, monitoring device 12 comprises a vascular Doppler sensor that can
gather
pulse waveform data, and analysis software for generating waveforms from the
sensor is
provided in server 18.
Client system 14A executes a vascular data client application I5, browser 17,
and
operating system 19. Vascular data client application 15 provides data
gathering, data
communication, and treatment planW ng functions, and is described in further
detail in a
separate section below. Browser 17 is a convention HTML browser program such
as
Netscape Communicator, Microsoft Internet Explorer, etc. Operating system 19
may be
the Microsoft Windows~ operating system, Mac OS, LINUX, or a similar system
that
can supervise and control higher-level applications and manage data input and
output.
Client system 14A is communicatively coupled, directly or indirectly through
one
or more routers, switches, gateways, or other network equipment, to a public
data
network 16. In one embodiment, network 16 is the set of interconnected global
internetworks known as the Tnternet.
A second client system 14B, associated with a healthcare provider 30, also is
communicatively coupled to network 16. The healthcare provider 30 is a
physician or
other healthcare professional that is involved in treatment of patient 10. For
example,
healthcare provider 30 may be a personal physician of patient 10 and the
client system
14B may be located in the office or clinic of that physician. The client
system 14B also
may be located in a location outside the clinical setting, including mobile
locations or
informal evaluation and treatment locations; no specific treatment location is
required.
Healthcare provider 30 also represents an institution such as a hospital or
other
facility and its personnel who may be involved in treating patient 10. Client
system 14B
also executes the software elements shown with respect to client system 14A.
In certain
embodiments, client system 14A executes a physician version of client
application 15,
which offers functions of interest or appropriate to physicians.
In this description, the terms "physician" and "healthcare provider" are used
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interchangeably and are intended to broadly refer to physicians, nurse
practitioners,
nutritionists, chiropractors, psychologists, psychiatrists, alternative health
providers,
hospitals, clinics, and similar healthcare personnel or institutions.
For purposes of illustrating a clear example, in FIG. 1 only one client system
14A
is shown in association with one patient 10 and only one client system 14B is
shown in
association with one healthcare provider 30. However, in a practical
embodiment, there
may be any number of client systems, patients, and healthcare providers
concurrently
connected to network 16, and the use of thousands or millions of such clients
is
contemplated.
A server 18 is communicatively coupled to network 16. A detailed description
of
server 18 is provided is a further section below. In one embodiment, server 18
is an
enterprise-server class computer system that executes a vascular analysis
application 20,
Web server 24, and operating system 22. In general, server 18 provides a
central point for
storage of patient data, treatment plans, and user information, and for
performing
administrative functions such as user registration, report generation, etc.
Server 18 also is
communicatively coupled to a database 26 for storage of patient data,
treatment plans,
user information, and system support information. Database 26 may be a
conventional
relational database system such as Oracle 8i, Microsoft SQL Server, Microsoft
Access,
etc.
Network 16 is communicatively coupled to client system 14A, client system 14B,
and server 18 using network links 13b, 13c, and 13d, respectively. Each link
13b, 13c,
13d to network 16 may be any kind of communication link, including wireless
links or
landline links.
Similarly, monitoring device 12 is coupled to client system 14A by a link 13a,
which may be wireless or wired. In still another embodiment, monitoring device
12
incorporates a processor, cellular RF modem and appropriate software that
enable
wireless communication of data between monitoring device 12 and either server
18 or
client system 14A through a network. In wireless embodiments, signals pass
through one
or more wireless gateways and may traverse one or more wireless networks in
addition to
network 16.
The server 18 and client systems 14A, 14B each are provided with means for
ensuring system security and protecting the privacy of patient information.
For example,
hardware elements such as firewalls may be used, and software mechanisms such
as
passwords, user authentication, and encrypted data communications may be used.
FIG. 2 is a flow diagram that provides an overview of a method of improving
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vascular function in humans, using the system of FIG. 1, according to one
embodiment.
In FIG. 2 and all other flow diagrams provided herein, the order of steps
presented is not
a required order, unless otherwise explicitly stated herein. Further,
additional steps may
be introduced and one or more steps may be omitted without departing from the
spirit and
scope of the invention.
In block 202, a patient arrives at a medical office for treatment. In
alternative
embodiments, described fizrther herein, a patient may interact with elements
of the system
of FIG. 1 at any location; thus, interaction at a medical office is not
required. In block
204, the patient provides and a healthcare provider at the medical office
receives medical
history information from the patient and any available pre-existing laboratory
test results.
For example, the patient and/or the healthcare provider complete a medical
history of the
patient that identifies family history factors relating to vascular disease,
and evaluate any
available laboratory test results.
In block 206, the medical staff receives or more physiological data
measurements
associated with the patient. For example, the healthcare provider performs
data gathering
for the patient, performs one or more physiological tests in the medical
office, or requests
one or more new laboratory tests. Data gathering may involve, for example,
performing a
physical examination of the patient and measuring one or more physiological
data values
of the patient, such as age, height, weight, blood pressure, body mass index,
etc.
Physiological testing may involve performing a Doppler vascular study,
obtaining a pulse
oxymetry value, determining blood cholesterol values, etc.
As indicated by arrow 208, at block 206 a first biofeedback interaction may be
performed. The biofeedback interaction of arrow 208 may comprise communication
between physician and patient consisting of use of 3D models, an illustration
of goals,
reminders of patient goals, affirmations by the patient, or other messages of
the physician
to the patient.
In block 210, the data obtained in block 204 and block 206 is transmitted
across a public
data network, such as the Internet, to a data center that has facilities for
storing and
analyzing the data. For example, referring again to FIG. 1, the data is sent
from the client
system 14B of healthcare provider 30 to server 18. Data communication between
client
system 14B and server 18 may use conventional techniques such as HTTP
messaging,
calls to Java Server Pages (JSPs), submission of data to HTML forms, etc. In
one specific
embodiment, data from a vascular study performed at the medical office is sent
through
network 16, with or without assistance by one or more wireless networks, to
server 18,
where a software program will analyze, interpret, and store data; the software
uses one or
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more accepted medical algorithms and evaluates and recommends treatment
programs for
hypertension, elevated cholesterol, diabetes, nutrition, exercise, or stress
reduction.
In block 212, the data is analyzed using one or more vascular health analysis
algorithms. For example, vascular analysis application 20 (FIG. 1) is provided
with the
data values, executes one or more algorithms that analyze the data values, and
generates
one or more treatment plans and/or recommendation messages as a result.
In block 216, the treatment plans, recommendation messages, and any other data
generated by the data center (e.g., server 18 of FIG. 1) are transmitted over
the public data
network to the healthcare provider. For example, data developed by server 18
is
communicated through network 16 to client system 14B. In block 218, the
medical staff
and the patient receive the data that was provided by the data center. In
block 220, the
medical staff and the patient evaluate the data provided by the data center to
determine a
course of action. For example, a healthcare provider can interpret the data
provided by the
data center, modify the treatment plans, explain treatment plan options to the
patient, etc.
As part of block 220, as indicated by arrow 222, a second biofeedback event
may be
performed. Examples of suitable biofeedback events axe described in further
sections
below.
In block 224, the healthcare provider and the patient initiate one or more
medical
programs consisting of using one or more treatments, using one or more
medications,
viewing videos or interacting with computer-displayed graphical 3D models. As
part of
block 224, as indicated by arrow 226, a third biofeedback event may be
performed. In one
embodiment, for example, the third biofeedback event of arrow 226 involves the
patient
viewing a computer display showing a graphical 3D model of the vascular system
while
the patient is connected to a blood pressure monitor and pulse monitor. While
viewing the
graphical 3D model, the patient cm perform relaxation exercises or other
therapy and
observe, in real time, the effect of the therapy on the function of the
patient's vascular
system. As another example, while the patient is connected to equipment that
measures
and displays blood pressure and changes in Doppler vascular waveforms, the
patient
hears an audible signal corresponding to pulse action in the vascular system,
and sees an
animated graphical display of vascular wall movement that is proportional to
the data that
is then currently being gathered in real time.
In block 228, the patient interacts with the medical program remotely using
computer access to the public data network. For example, refernng to FIG. 1,
while
located at home, a workplace, or any other desired location, the patient
connects client
system 14A to network 16. The patient then interacts locally with vascular
data client
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application 15, and remotely with server 18 and server application 20. As part
of block
228, as indicated by arrow 230, a fourth biofeedback event is performed. For
example, at
home, the patient connects monitoring device 12 to the patient while client
system 14A is
connected through network 16 to server 18. The patient then performs an
athletic activity,
e.g., by using a home treadmill, exercise bicycle, etc. During the athletic
activity, the
patient may observe data values associated with the patient's vascular
functions in real .
time on the display of client system 14A. The patient can then adjust how the
patient is
performing the athletic activity to favorably affect the vascular system.
Alternatively, the
patient can perform relaxation activities, view educational videos, etc. Use
during
athletic activity is not required; the monitoring device 12 may be used and
data values
may be observed before or after the athletic activity.
In block 232, data generated by the medical program as part of block 228
and/or
block 230 is communicated over the public data network to the data center. For
example,
real-time vascular data, or user input to the vascular data client application
15 that was
provided in non-real-time, is communicated to server 18. In block 234, the
data center
stores the data values representing patient interaction with the system. Block
234 may
also involve modifying one or more treatment plans or recommendations that
were
previously generated by the data center.
Thereafter, control flows optionally to either block 204 or block 212. The
steps of
FIG. 2 may iterate any number of times as the patient and healthcare provider
perform
additional activities, biofeedback events, data gathering and analysis
functions, treatment
program modifications, etc.
Vascular risk evaluation performed in the foregoing manner achieves numerous
useful objectives. For example, vascular disease risk may be evaluated for
both
asymptomatic and symptomatic patients. The clinical skills of physicians in
vascular
medicine are improved. Patient treatment outcomes are determined and recorded
for
evaluation. Patients participate in their own treatment over an extended
period of time.
2.0 STRUCTURAL DETAILS OF ONE EMBODIMENT
2.1 VASCULAR DATA MEASUREMENT DEVICE
FIG. 3 is a block diagram of a vascular monitoring device, according to one
embodiment.
Monitoring device 12 comprises a processor 210 having a battery 208 that
serves
as a power supply and a clock 212 that provides synchronization signals.
Processor 210
may be a microprocessor, micro controller, etc. Program instructions and data
for
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controlling operation of processor 210 are stored in a read-only memory (ROM)
214 and
random-access memory (RAM) 216; in certain embodiments, ROM 214 and RAM 216
are integrated with processor 210 in the form of on-chip storage. A Universal
Serial Bus
(LTSB) interface 218 terminates at a USB port 220 for connecting the
monitoring device to
a personal computer, peripherals, or any other suitable system.
Monitoring device 12 further comprises a pulse data interface 202, oxymetry
interface 204, and blood pressure interface 205 that are respectively coupled
to probes
206A, 206B and a blood pressure cuff 207. In one embodiment, probes 206A, 206B
are
integrated into a housing that contains and protects the other elements of
FIG. 3, forming
a self contained manually graspable monitor that may be easily and
conveniently used in
a variety of personal physical activities. Probe 206A, for receiving pulse
data, may be
structured for attachment to a forger, wrist, ankle, or other external
anatomical structure
having a superficial pulse point. Probe 206B, for receiving oxygen saturation
information,
may be structured for attachment to a fingernail or toenail. Cuff 207 may be
affixed to a
forger, wrist, arm, ankle, etc.
Further, in one specific embodiment, probe 206A functions as an acoustic
vascular Doppler sensor that can gather acoustic pulse waveform data, and
analysis
software for generating waveforms from the sensor is provided in server 18. In
this
embodiment, probe 206A is secured to a pulse point at one of the extremities
of the
vascular system, such as the ankle. Alternatively, a separate wand, probe or
other sensor
may be provided for collecting acoustic Doppler vascular data, for analysis by
software in
server 18. Such server software is operable to create and store data
representing one or
more vascular data waveforms, in graphical form or in terms of raw data
values, based on
acoustic signals obtained by probe 206A. Thus, monitoring device 12 serves as
a data
gathering mechanism whereas server 18 analyzes and generates graphical images
and
other interpretations of the acoustic data that is gathered.
Further, in this arrangement, measurements of pulse, blood pressure, and pulse
oxymetry are received by processor 210 when the monitoring device 12 is
gripped by a
patient or other user. Data values are determined by processor 210 in
cooperation with
interfaces 202, 204, 205 and provided to RAM 216 or to external systems and
applications through USB interface 218. For example, under program control,
client
system 14A can read data values for a patient pulse, blood pressure, and
oxymetry by
sending appropriate messages to processor 210 through USB interface 218 and
receiving
responsive messages with the data values.
Optionally, monitoring device 12 incorporates an RF interface 219, antenna and
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appropriate software that enables wireless communication of data between
monitoring
device 12 and either server 18 or client system 14A through a network. With
wireless
cormnunication, monitoring device 12 is easily transported by the user for use
during an
exercise activity, biofeedback interaction, or other activity.
2.2 VASCULAR DATA CLIENT APPLICATION
FIG. 4 is a block diagram of a vascular data client application, according to
one
embodiment.
Vascular data client application 15 principally comprises, in this embodiment,
a
presentation layer 404, treatment plan engine 406, and data transfer engine
408. Each of
the foregoing elements may be implemented using one or more computer programs,
programmatic objects, or other software elements, using any desired language
system. In
one embodiment, each of the foregoing elements comprises one or more Java~
classes.
Presentation layer 404 is responsible for receiving data from subordinate
layers
and presenting the data to a user. In one embodiment, presentation layer 404
calls
functions of a browser dynamic linked library (DLL) associated with an
operating system
412 of the client system 14A in order to generate output that is readable
using browser 17
of the client system. Alternatively, presentation layer 404 may call windowing
and
display functions of the operating system 412; in still another alternative,
the presentation
layer generates a bitmapped graphical display.
Treatment plan engine 406 is responsible for generating one or more treatment
plans for a patient user, for presenting one or more treatment plans to the
user, managing
patient interaction with the treatment plans, and for evaluating and modifying
one or more
treatment plans that are received from server 18. Treatment plan engine 406
interacts with
a local data store 414, which contains one or more patient data values 414A
and one or
more treatment plans 414B. Local data store 414 may comprise a database stored
in local
disk storage of client system 14A. For example, Microsoft Access may be used
for local
storage, or a proprietary data format may be used. Treatment plans 414B also
may include
one or more video streams, audio streams, graphical models of anatomic or
physiological
elements, etc.
Data transfer engine 408 is responsible for managing communication of data
from
vascular data client application 15 to other software or systems. For example,
data
transfer engine 408 interacts with a device interface 416 to obtain
physiological data
values from monitoring device 12. Alternatively, data transfer engine 408
interfaces with
TCP/IP stack 410 of operating system 412 to communicate data using HTTP over a
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public data network.
2.3 DATA CENTER SERVER ARCHITECTURE
FIG. 5 is a block diagram of an architecture of a vascular data center server,
according to one embodiment.
liz the embodiment of FIG. 5, data center server 18 is coupled to network 16
through a firewall 502 that allows only authorized data traffic to enter the
data center
server. In certain embodiments, server 18 is coupled to a wireless gateway 501
that is in
turn coupled to one or more wireless networks. In this arrangement, server 18
can send
and receive data using traditional landline mechanisms such as the Internet or
through
wireless networks.
The server 18 is, in one embodiment, a server-class computer that executes an
application server 504 and server application 20. An example of suitable
application
server software is a Java 2, Enterprise Edition (J2EE) application server such
as those
commercially available from WebLogic. However, embodiments are not limited to
use of
a J2EE application server, and any other suitable application server may be
used.
Server application 20 comprises control functions, treatment plan engine
functions, invoicing and payment functions, and data transfer functions.
Further, in one
embodiment, server application 20 interacts with a plurality of software
services that
perform support functions. In the embodiment of FIG. 5, such services
including a
presentation service 512, registration service 516, aclininistration service
518,
authentication service 520, wireless data service 514, data transfer service
SIS, system
service 511, and database service 510.
Presentation service 512 is responsible for receiving HTTP requests from
clients
and rendering content. In one embodiment, content rendering is performed using
a
combination of Java servlets and Java Server Pages (JSPs). The presentation
service 512
may comprise an image server, panel, and servlet controller. The image server
is
responsible for rendering images that are requested by a client browser,
including images
that form part of a medial program or treatment plan. The panel is responsible
for
receiving user interface elements of a medical program or treatment plan, and
rendering
them by ordering and laying out the elements. The panel also performs device-
specific
rendering. The servlet controller is responsible for receiving and processing
servlet
requests and dispatching the servlet requests to a specific subsystem. The
servlet
controller may comprise a plurality of different servlets, and serves as a
central point for
retrieving data that is used in JSP pages.
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Registration service 516 is responsible for registering patient users and
healthcare
users in the system by recording identification information, passwords, and
related data.
The administration service 518 is responsible for enabling editing and
configuration of
the application server 504, including creation, update and deletion of users
and groups of
users, data communication settings, etc. Authentication service 520 is
responsible for
receiving requests of users to log-in to or use the system, verify passwords,
and otherwise
authenticate users before services axe offered to them. Wireless data service
514 is
responsible for dispatching data to and receiving messages from wireless data
services,
e.g., through wireless gateway 501.
Database service 510 manages interaction with a database 508. The database 508
may be a conventional relational database system that stores a patient data
table,
healthcare provider data table, treatment plan table, and system data. For
security or
privacy reasons, any of the foregoing tables may be maintained in a separate
database
server.
In one embodiment, system service 511 comprises auditing, caching, logging,
offline, persistence, and time service components. The auditing component
enables
creation of an audit trail in database 508 that identifies functions performed
by other
system elements. The caching component enables caching of objects including
treatment
plan data, user data, images, text, and other programmatic objects. The
logging
component supports an operational log in database 508 for debugging and error
evaluation purposes. The offline component allows a client to receive
notification of
changes in information that occurred when the client was disconnected from
network 16;
in one embodiment, the offline component interacts with an offline client plug-
in at each
client 14A, 14B, which is omitted for clarity. The persistence component
encapsulates
stored procedures that axe used to read and store data. The time service
component allows
persistent, recurring actions to be created and scheduled.
In certain embodiments, server 18 and server application 20 provide a hosted
service to one or more patients 10 and healthcare providers 30. Thus, an
entity that owns
or operates server 18 may function as an application service provider that
makes services
of server application 20 available to patients 10 and healthcare providers 30
on fee basis.
Fees may be collected on a monthly or subscription basis, or on a pay-per-
service basis.
For example, a fee may be imposed on a healthcare provider for each clinical
study that is
carried out on a patient; access to resulting data may be included in the fee,
or priced
separately.
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3.0 FUNCTIONAL DETAILS OF ONE EMBODIMENT
The description of certain functions below may refer to actions that may be
taken
by a user, client or system. Alternatively, for simplicity, the description
may refer only to
a user; however, in that case, the term "user" is meant broadly to refer to an
individual
acting through an appropriate computer user interface, or to a client computer
interacting
programmatically with an appropriate machine interface, or to an external
server,
software application, or other computer system interacting programmatically
with an
appropriate machine interface. Thus, all references to user action are
intended broadly and
not as limited to individual human user action.
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3.1 NETWORK BIOFEEDBACK VASCULAR DISEASE TREATMENT
METHOD
FIG. 6A is a flow diagram that illustrates one embodiment of a network
biofeedback vascular disease treatment method. In the approach of FIG. 6A, a
patient
who is undergoing treatment for vascular disease interacts with a medical
program using
a software program and a client system such as a personal computer. In another
approach,
which is described further herein, the patient may interact with a medical
program that is
hosted on a server that is accessed by the patient over a data network, such
as the Internet.
In a third approach, the patient may interact with the program under physician
care in a
medical office, hospital, or other healthcare site.
W another alternative embodiment, institutions such as managed care
organizations, community centers, hospitals, insurance companies, and
employers
offering employee assistance programs may interact with the server application
or client
application. In still another alternative, researchers such as those
affiliated with
universities may interact with the server application or client application to
perform
research based on data stored at the server, and correlated with other
investigation
protocols in the area of vascular diseases evaluation, treatment, and follow
up.
In each of these approaches, the medical program provides an educational
component in which video information, audio information, and/or 3D graphical
models
show normal and abnormal physiology and structures relating to the circulatory
system
and heart. The patient may interact with such audiovisual information in order
to
understand the effect of various activities and medications on the physiology.
Thus, the
audiovisual interactions help to illustrate dramatic changes that can occur in
vascular
disease.
One or more of such audiovisual interactions may involve a biofeedback
component. Thus, a patient may evaluate the patient's own circulation and
other vascular
characteristics by viewing and hearing the audiovisual information. For
example, using a
monitoring device, the client system can receive and display blood pressure
and Doppler
vascular wavefonn data for observation by the patient. The client system can
concurrently
audibly play acoustic data obtained from the patient using the Doppler
vascular monitor
in the monitoring device, enabling the patient to hear their pulse and
circulatory
characteristics. Over time, by applying one or more treatment plans, the
patient may see
and hear changes in the patient's physiology, resulting in positive
improvement in
vascular health.
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The frequency of such interactions may vary. For example, a physician may
recommend one or more periodic evaluations, such as monthly, or three times a
year,
depending on risk factors associated with the patient and the patient's
physical condition.
Data gathered by the client system or the server may be used in long-term
formal
studies of populations of patients, or by the physician and patient for long-
term study of
the patient's improvement. For example, data gathered by the client system or
the server
may be used to monitor lifestyle changes, such as changes in diet, exercise,
and
performance of stress reduction exercises. The data gathered by the system may
be used
to measure the effect of medications or dietary supplements that the patient
is taking.
Researchers may use the data, on an aggregated or anonymous basis, to compare
and
correlate with other study data or other treatment approaches. For example,
researchers
may compare the effectiveness of biofeedback and lifestyle adjustments to
invasive
imaging approaches or to surgical approaches.
Further, clinical studies become more accessible in both cost and
availability.
Physicians and patients have permanent, continuous online access to
information about
patient health; physicians can remotely evaluate and monitor patients on a
long-term basis
without requiring an unreasonable number of clinic or office visits.
In one embodiment, the foregoing approaches may be integrated with other
medical treatment. For example, the foregoing approaches may be performed in
conjunction with prescription of drugs classified as calcium channel blockers,
ACE
inhibitors, ACE blockers, vitamin B12 or niacin therapy, etc., which have been
found to
avoid the side effects associated with beta-blockers, and to concurrently
promote
circulation in all tissues. Using these approaches, significant benefits in
treatment may be
realized. These benefits may include increased circulation in the extremities,
heart and
brain; control of migraine headache; control and reversal of early Alzheimer's
disease;
increased coronary circulation; increased capacity for exercise; increased
circulation to
the sexual organs resulting in improved sexual function; and other benefits.
The approaches described herein may include biofeedback principles,
meditation,
and progressive relaxation techniques in combination with physiological
measurements
obtained from Doppler vascular monitors and other devices. These treatment
modalities
are usually given and instructed by medical and paramedical providers; in
contrast, in the
present approaches they are achninistered by the physician and patient.
The approaches herein therefore can save time and money in the course of
treatment, and can increase the skills and effectiveness of the user in
addressing specific
physiological goals, such as to reverse or prevent cardiovascular disease and
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complications, for example heart attacks and strokes. The primary healthcare
provider or
physician can assist the user-patient with further recommendations and follow
up, having
seen the above exercises and treatment results.
In a similar mariner, the server application and client application can assist
the
user to address other treatment recommendations, such as lifestyle changes.
For example,
embodiments can recommend one or more exercise plans. In this approach, a user
attaches monitoring device 12 in order to gather data values for blood
pressure, vascular
pulses, and oxygen saturation, while riding a stationary bike or a treadmill
at home. Client
application 15 stores and analyzes the data values before the exercise regimen
begins,
during a period of exercise, and during the cool down period of exercise.
Client
application 15 is provided with safety parameters that suggest a protocol or
level of
exercise to the user based on the physiological data values previously
gathered and stored
at the server.
In another embodiment, vascular data client application 15 and vascular data
server application 20 provide a nutrition evaluation and recommendation
function. To
support the nutrition function, the patient completes a software-driven or
online
questionnaire that gathers data about the type of foods recently consumed by
the user, the
amount of the goods, how the foods were prepared, and other data. The user
submits the
completed questionnaire to the server 18 using server application 20, or saves
the
completed questioimaire locally using client application 15. W response,
applications 15,
20 provide an evaluation of the nutritional content of the foods identified by
the user. The
report specifies the amount of proteins, carbohydrates, fat, cholesterol, poly-
and
monounsaturated fats, salt, minerals and vitamins, fiber content, and other
characteristics
of the foods.
The nutrition function then generates one or more suggested meal plans or
dietary
plans. The nutrition plan function generates the dietary plans based on an
evaluation of
data values retrieved from database 26, such as weight, cholesterol levels,
blood pressure
and other factors. The nutrition plan function may also prompt the user to
provide
additional data values representing factors such as user preferences, etc.
In still another embodiment, input from a digital video camera or digital
still
camera is received at client system 14A and communicated over network 16 to
server 18.
Periodically during interaction with a user, client application 15 requests
the user to place
the camera in position for recording an image, and then receives and records
one or more
digital images of the user. The digital images are communicated over network
16 to
server 18. Client application 15 and server application 20 may use the images
for
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documentation of body weight; evaluation of facial expressions to measure
tension and
anxiety; and for recording skin torpor and coloration to assist in evaluating
circulation.
The digital image information also may be used to enable a healthcare provider
to
monitor the biofeedbaclc functions that are performed by the user.
3.2 INTERACTION WITH USER ALONE (AFTER INITIAL PHYSICIAN
EVALUATION)
A specific approach involving interaction of a user or patient with client
application 15 and server application 20 is now described with reference to
FIG. 6A. In
block 602, the patient arrives at a computer desk or similar location at which
client
system 14A is located. Block 602 may also involve activating a PDA or wireless
device at
any location; embodiments are not limited to home use.
In block 604, the patient fills out a data form to provide basic physiological
information, including medical lustory information, in response to prompts
from vascular
data client application 15 (FIG. 1). Typically block 604 is performed after an
initial
physician evaluation of the patient. Block 604 may also involve receiving data
identifying
medications that the patient is then currently taking in order to facilitate
risk analysis. In
block 606, the user uses a monitoring device to provide blood pressure,
Doppler vascular
data values, and blood oxygen saturation values. Thus, block 606 may involve
the user
affixing monitoring device 12 to the user's body and activating a function of
client
application 15 that retrieves the data values from the monitoring device. The
data values
are stored locally at client system 14A.
As data values are gathered in block 606, a biofeedback mechanism is
performed,
as indicated in block 608. In one embodiment, the biofeedback mechanism of
block 608
involves client application 15 generating and displaying a real-time graphical
representation of the data values that the monitoring device 12 is gathering.
For example,
client application 15 may generate a display depicting an artery in cross-
section and
animate the displayed artery in coordination with data pulses that are
collected by the
Doppler vascular monitor. The patient can visualize the patient's
physiological condition
and can modify certain physical characteristics, such as breathing rate, in
order to result in
other internal modifications.
In block 610, data collected by the patient is sent to a data center for
analysis. For
example, data obtained by the monitoring device 12 and stored by client system
14A is
communicated over the public data network 16 to the server 18. In block 612,
one or
more analysis algorithms are applied to the data provided by the patient or
through the
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monitoring device, to result in generating one or more reports, treatment
plans, or other
output data that may be useful to the patient for treatment.
Block 612 may also involve performing a risk analysis for the patient, the
results
of which may be reported to the patient in later steps, e.g., block 616.
Operation of the
process of FIG. 6A may vary depending on the results of the risk analysis. For
example, if
the analysis of block 612 determines from the data entered by the patient that
the patient
is categorized as "low risk" for cardiovascular events, then the user would be
able to
utilize the other steps of the method in the patient's discretion. Block 612
may also
involve issuing a recommendation that that patient give copies of the reports
to the
patient's treating physician, who may have additional recommendations.
If the user is on treatment programs with a healthcare provider, e.g., taking
blood
pressure medications, then block 612 may request the patient to take other
action, and
may prevent the patient from carrying out other steps in FIG. 6A, such as
performing
biofeedback interactions as described below with respect to block 624, 626,
etc. Such
control may be enforced by client application 15 or server application 20. For
example, if
the user is on blood pressure medications, is diabetic, or has other symptoms,
then
algorithms embodied in client application or server application 20 may
instruct the patient
to consult a physician for a recommendation of treatment parameters.
If the patient is categorized as "high risk," then client application 15 may
recommend that the patient should not engage in certain biofeedback
interactions, such as
the exercise interaction described herein with respect to FIG. 9, without the
direction of a
personal physician. However, under control of client application 1 S, a
patient 10 who is
classified as "high risk" may still perform other functions of the program.
For example,
the "high risk" patient may perform biofeedback interactions relating to
stress reduction,
weight loss and nutritional modifications.
In block 614, the reports, treatment plans, or other result data are
communicated to
the patient. For example, such result data is sent from server 18 over network
16 to client
system 14A for use by client application 15.
In block 616, the patient uses the received data in one or more local patient
interactions. For example, client application 1 S displays a graphical model
that enables
the patient to view pathological changes with respect to the arterial walls.
As a result, a
biofeedback mechanism occurs, as indicated by arrow 618.
In block 620, the patient and a physician evaluate the result data. For
example, the
physician can interpret the result data and provide one or more specific
recommendations
to the patient for improving vascular health. Alternatively, the physician can
confirm the
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recommendations embodied in the result data and request the patient to begin a
medical
program as outlined in the result data. Through this process, a biofeedback
interaction
occurs, as indicated by arrow 622.
In block 624, the patient selects and performs one or more biofeedback
processes.
Specific biofeedback processes are described further herein in connection with
FIG. 7,
FIG. ~, FIG. 9, and FIG. l0A-10B. In one embodiment, client application 15
displays a
menu of available biofeedback interactions that can be facilitated using the
client
application, for example, using a graphical user interface. The patient 10
provides user
input to client system 14A that selects one of the biofeedback interactions.
Examples
include a progressive relaxation interaction, nutrition interaction, exercise
interaction, an
interaction relating to medication effects, etc. In response, client
application 15 generates
graphical displays or images, plays audio files, or plays video information to
lead the
patient 10 through the biofeedback interaction. As a result, biofeedback to
the patient
occurs, as represented by arrow 626.
Patient participation in the biofeedback interactions that are selected in
block 624
may result in generating further patient physiological data or response data.
In block 62~,
such response data is communicated to the server for processing and analysis.
In
response, the server analyzes and evaluates the response data based on one or
more
algorithms or medical calculators. Data resulting from such analysis and
evaluation is
presented to the patient, resulting in further biofeedback as indicated by
arrow 630.
In block 632, the result data is communicated over the data network to the
patient.
Thereafter control may return to block 604 in which the patient may provide
further
physiological or history data and repeat one or more of the foregoing steps.
Thus, a
patient may iterate the process of FIG. 6A one or more times as determined by
the patient
or by the patient in consultation with a physician, to result in improvements
to vascular
health.
In this approach, the user can perform self evaluation of the user's medical
condition, self treatment of one or more symptoms, and can follow up on the
patient's
physical progress, physiological data, and health reports.
FIG. 6C is a flow diagram that illustrates a further embodiment of a network
biofeedback vascular disease treatment method. In block 634, a patient arrives
at a
computer desk or similar facility at which a PC, PDA, or other client system
is located.
For example, patient 10 (FIG. 1) arnves at a location of client system 14A. In
block 636,
the patient provides one or more data values to the client system in response
to prompts
that are provided under program control. For example, client application 15
prompts the
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patient to enter height, weight, and similar physiological values, information
identifying
the patient's physician, medical history and medication information, etc.
Blocks 634, 636
may involve the same processes as blocks 602, 604 of FIG. 6A.
In block 638, a test is performed to determine whether the patient should be
classified as high risk. Block 638 may involve, for example, evaluating the
information
entered in block 636 using one or more medical calculators or algorithms that
identify
risk factors. Risk factors may include, for example, a high weight value
indicative of
morbid obesity; excessively high cholesterol values; high blood pressure
values; a family
history of early death because of vascular disease; dietary factors; the
presence of
diabetes; and other factors. If the patient is identified as "high risk" in
block 638, then
control is transferred to block 640 in which the client application requests
the user to
consult with a treating physician. After doing so, the patient may resume
operation at
block 634.
If the test of block 638 is negative, then control passes to block 642. In one
embodiment, client application 15 generates a graphical display or audiovisual
program
that illustrates normal changes on the walls of arteries. Thus, an educational
program that
illustrates normal physiology of the cardiovascular system is provided. In
block 644,
client application 15 generates an additional display or audiovisual program
that shows
pathological changes on the walls of arteries. This provides the patient with
an
audiovisual educational illustration of goals of treatment and consequences of
failure to
address vasculax disease.
The program generated as part of block 644 may follow the abnormal changes
that
occur with various degrees of disease of the vascular system. Video graphics
may
illustrate these normal and abnormal changes on the walls of the arteries. For
example, an
audiovisual graphical display may illustrate how the artery wall stretches
normally when
minimal plaque formation is present, and may illustrate how the artery is
affected with
increased plaque formation or arteriosclerosis. The audiovisual graphical
display may
also illustrate chemical components of the plaque formation, e.g., calcium,
fats,
cholesterol, etc.
In block 646, the user uses a monitoring device to measure physiological data
values of the user. In one embodiment, monitoring device 12 is used. The
monitoring
device 12 may comprise a blood pressure monitor, Doppler vascular monitor, and
pulse
oxymeter, and may provide data values representing the patient's blood
pressure, pulse,
vascular acoustics and waveforms, and blood oxygen saturation to client
application 15.
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In block 648, the data values generated by the monitoring device are received
at
the client application and sent over a data network to a server at a data
center. For
example, HTTP communications initiated by Web~browser 17 under control of
client
application 15 may be used to send data values in HTML forms, or other data
transfer
mechanisms, to server application 20 of server 18 under control of Web server
24.
In block 650, the server receives the data sent in block 648. In one
embodiment,
each user or patient who wishes to use the process of FIG. 6B first registers
with the
system of FIG. 1 and receives a username and password. The username and
password are
associated with a unique user account at server 18 and a segregated storage
area in
database 26. The data values that are sent in block 648 are stored in the
user's account.
Block 650 also involves processing and evaluating the physiological data
values based on
one or more algoritlnns or medical calculators. As a result, one or more sets
of treatment
plans, recommendations or other result data are generated.
W block 658, the patient may continue with one or more other biofeedback
processes. For example, client application 1 S or server application 20 may
generate and
present one or more menus to the patient and prompt the patient to select one
or more
biofeedback interactions. As examples, the biofeedback interactions of FIG. 7,
FIG. 8,
FIG. 9, or FIG. 10A-1 OB may be selected. As indicated by block 660 and the
loop formed
with block 658, selection and use of biofeedback interactions may iterate one
or more
times.
Performing the biofeedback interactions as part of block 658, block 660 may
result in client application 15 generating one or more result data values.
When the patient
is satisfied with use of the biofeedback interactions, then control passes to
block 662, in
which the server processes the result data values by applying one or more
algorithms or
medical calculators. As a result, further result data values, treatment plans,
or
recommendations are generated. In block 664, the further result data values,
treatment
plans, or recommendations are provided to the user. In one embodiment, block
664
involves storing the further result data values, treatment plans, or
recommendations in the
user's account at server 18 and generating an alert message that informs the
user that the
further result data values, treatment plans, or recommendations are available
for review or
evaluation.
In block 668, a determination is made regarding whether the further result
data
values, treatment plans, or recommendations represent a reduction or increase
in vascular
health. The test of block 668 may involve self analysis by the patient or
automatic
analysis by client application 15 or server application 20. If a reduction is
identified, then
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control passes to block 640 in which a physician may perform a further
clinical
consultation with the patient. If an increase is identified, then improvement
in health is
signified, as indicated by block 670. The patient may then proceed with
additional
monitoring, at block 646, or with further biofeedback interactions.
3.3 INTERACTION WITH USER AND HEALTHCARE PROVIDER
FIG. 6B is a flow diagram that illustrates a second embodiment of a network
biofeedback vascular disease treatment method involving both a user or patient
and a
healthcare provider. The approach of FIG. 6B may be used by physicians, nurse
practitioners, nutritionists, chiropractors, psychologists, psychiatrists,
alternative health
providers, and others as an integral part of their evaluation and treatment
protocol.
Tn one embodiment, the process of FIG. 6B is implemented using a provider-
specific version of vascular data client application 15 (FIG. 1) that is
executed at client
system 14B in coordination with provider-specific functions of server
application 20.
Alternatively, client systems 14A, 14B may execute the same client application
15 in
which a provider version has certain provider-specific functions enabled and a
patient
version has the provider-specific functions disabled.
Refernng now to FIG. 6B, in block 634 a patient arrives at a computer desk or
similar facility at which a PC, PDA, or other client system is located. For
example,
patient 10 (FIG. 1) arrives at a location of client system 14A. In block 636,
the patient
provides one or more data values to the client system in response to prompts
that are
provided under program control. For example, client application 15 prompts the
patient to
enter height, weight, and similar physiological values, information
identifying the
patient's physician, medical history and medication information, etc.
In block 638, a test is performed to determine whether the patient should be
classified as high risk. Block 638 may involve, for example, evaluating the
information
entered in block 636 using one or more medical calculators or algorithms that
identify
risk factors. Risk factors may include, for example, a high weight value
indicative of
morbid obesity; excessively high cholesterol values; high blood pressure
values; a family
history of early death because of vascular disease; dietary factors; the
presence of
diabetes; and other factors.
If the patient is identified as "high risk" in block 638, then control is
transferred to
block 640 in which the client application requests the user to consult with a
treating
physician. After or during such a consultation, the treating physician
determines whether
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the patient is in a condition appropriate for continued use of the process of
FIG. 6B; if so,
then the patient may resume operation at block 634 or block 642.
If the test of block 638 is negative, then control passes to block 642, in
which
client application 15 generates a graphical display or audiovisual program
that illustrates
normal changes on the walls of arteries or other structures of the vascular
system. In
block 644, client application 15 generates an additional display or
audiovisual program
that shows pathological changes on the walls of arteries or other structures
of the vascular
system. This provides the patient with an audiovisual illustration of goals of
treatment and
consequences of failure to address vascular disease.
W block 646, data is generated using a monitor. For example, the user uses a
monitoring device to measure physiological data values of the user. In one
embodiment,
monitoring device 12 is used. The monitoring device 12 may comprise a blood
pressure
monitor, Doppler vascular monitor, and pulse oxymeter, and may provide data
values
representing the patient's blood pressure, pulse, vascular acoustics, and
blood oxygen
saturation to client application 15.
In block 648, the data values generated by the montoring device are received
at
the client application and sent over a data network to a server at a data
center. For
example, HTTP communications initiated by Web browser 17 under control of
client
application 15 may be used to send data values in HTML forms, or other data
transfer
mechanisms, to server application 20 of server 18 under control of Web server
24.
In block 650, the server receives the data sent in block 648. In one
embodiment,
each user or patient who wishes to use the process of FIG. 6B first registers
with the
system of FIG. 1 and receives a username and password. The username and
password are
associated with a unique user account at server I8 and a segregated storage
area in
database 26. The data values that are sent in block 648 are stored in the
user's account.
Block 650 also involves processing and evaluating the physiological data
values based on
one or more algorithms or medical calculators. As a result, one or more sets
of treatment
plans, recommendations or other result data are generated.
In block 652, the result data are sent to the physician of the patient who was
identified by the patient in block 636. In one embodiment, each physician has
a user
account, and block 652 involves storing a reference to the result data in an
in-box at
server 18 that is uniquely associated with the physician. The physician may
access the in-
box by using a Web browser that is executed at client system 14B to connect to
server 18,
logging in with the physician's username and password, accessing a portal
display, and
selecting the in-box. The in-box may comprise a plurality of message entries.
When a
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message entry is selected and opened, server application 20 generates a
display of
pertinent patient data.
In block 654, the physician evaluates the result data. Such evaluation may
involve
reviewing physiological data value in comparison to a traditional patient
chart, consulting
references, and otherwise arriving at a determination of the patient's
condition and what
treatment is advisable. In block 656, the patient and the physician evaluate
the result data
together. Block 654 and block 656 may be combined in one operation. Block 656
may
involve an office consultation with the patient in which the result data are
displayed and
reviewed. Alternatively, block 656 may involve the patient and physician
engaging in a
scheduled telephone conference or on-line chat to discuss the data. In these
alternatives,
both the physician and patient may concurrently access and view the result
data by using
Web browsers at client systems 14A, 14B, respectively, to view data in the
patient
account and physician account that is stored at server 18. In yet another
alternative, the
process of FIG. l OB is used.
In block 658, the patient may continue with one or more other biofeedback
processes. For example, client application 15 or server application 20 may
generate and
present one or more menus to the patient and prompt the patient to select one
or more
biofeedback interactions. As examples, the biofeedback interactions of FIG. 7,
FIG. 8,
FIG. 9, or FIG. 10A-1 OB may be selected. As indicated by block 660 and the
loop formed
with block 658, selection and use of biofeedback interactions may iterate one
or more
times.
Performing the biofeedback interactions as part of block 658, block 660 may
result in client application 15 generating one or more result data values.
When the patient
is satisfied with use of the biofeedback interactions, then control passes to
block 662, in
which the server processes the result data values by applying one or more
algorithms or
medical calculators. As a result, further result data values, treatment plans,
or
recommendations are generated. In block 664, the further result data values,
treatment
plans, or recommendations are provided to the user. In one embodiment, block
664
involves storing the further result data values, treatment plans, or
recoxmnendations in the
user's account at server 18 and generating an alert message that informs the
user that the
further result data values, treatment plans, or recommendations are available
for review or
evaluation.
In block 666, the user's physician evaluates the further result data values,
treatment plans, or recommendations that were generated. In one embodiment,
block 664
may involve also sending an alert message to the physician that the user
identified in
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block 636, so that the physician is aware that new data for evaluation is
available. A
physician-formatted copy of the further result data values, treatment plans,
or
recommendations may be stored in the physician's in-box or in association with
the
physician's account.
In block 668, the physician determines whether the further result data values,
treatment plans, or recommendations represent a reduction or increase in
vascular health.
If a reduction is identified, then control passes to bloclc 640 in which the
physician may
perform a further clinical consultation with the patient. If an increase is
identified, then
improvement in health is signified, as indicated by block 670. The patient may
then
proceed with additional monitoring, at block 646, or with further biofeedback
interactions.
Further, in certain embodiments, a physician-specific version of client
application
15 and/or server application 20 offer certain additional features and
functions to
physicians or other healthcare providers. For example, a physician may enroll,
using
software functions provided by client application 15 at client system 14B and
server
application 20, in a teaching program that is provided by the owner or
operator of server
18 and relating to the use, interpretation, and benefits of the processes of
FIG. 6A, FIG.
6B.
In another embodiment, the healthcare provider may enroll in a research
organization that is involved in monitoring data gathered by server
application 20 and in
monitoring progress of patients who use client application 15, server
application 20, and
the processes described herein. In yet another embodiment, the provider may
register with
server 18 to join a referral list of individuals who need care or follow up,
and who do not
have a primary physician, or who are treated by a primary physician who does
not
participate in the methods described herein or in the system of FIG. 1.
In yet another embodiment, a physician may instruct server application 20 to
permit other physicians or healthcare providers to access data concerning
selected
patients that has been gathered by the server application. In tlus approach,
server 18
provides a centralized repository that is accessible by other physicians who
are
researching or treating vascular disease.
A healthcare provider may use the methods described herein only for an initial
evaluation of a patient. The provider may choose to follow one or more
different
treatment methods depending on his specialty and patient factors. The provider
may
participate in the system and methods described herein only with respect to
blood
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pressure and vascular health, or with respect to all other physiological
functions described
herein.
3.4 INSTITUTIONAL, UNIVERSITY AND RESEARCH USES
The system and methods described herein also may be used by institutions to
facilitate various healthcare programs. For example, client application 15 and
server
application 20 may be used, specifically as described herein or with
appropriate
modifications, in weight reduction programs, stress reduction programs, cancer
treatment
programs and support groups, diabetes treatment programs, cardiac
rehabilitation
programs, etc. In this approach, participants in such programs interact with
one or more
client systems 14A under control of client application 15, in the same manner
described
above. Administrators, supervisors, or physicians in charge of the
institutional programs
may access data and participate in the system using client systems 14B and
access to
patient data in server 18 under control of server application 20.
In the university and research context, the system and methods described
herein
may be used for evaluation of patients with potential vascular disease in
addition to those
recommendations made in the American Heart Association Scientific Statement
referenced above. The system and methods described herein can be used in
conjunction
with other currently used and on-going monitoring evaluations, such as
coronary and
cardiac catheterizations, ultrasound evaluations of cardiac status, etc.
3.5 BIOFEEDBACK MECHANISMS
In any of the foregoing embodiments, the user can interact further by
selecting one
or more biofeedback options or exercises. For example, assume that a patient
is viewing
an educational display generated by the program. The program prompts the user
to select
a biofeedback exercise. The patient selects a "Beach Stroll" biofeedback
exercise. In
response, the client system displays an oceanfront scene on the display of the
client
system. The client system then plays, using a sound system integrated into the
client
system, an audio file that states the following:
"Imagine yourself walking on the beach. You are concentrating on the sounds of
the waves. You are breathing slowly. You feel the cool misty ocean air. You
are feeling
the sand on your feet, on your hands, you are sitting. You are aware of the
sun shining on
you, then you are feeling warm and you are feeling this warmth passing to the
various
regions of your body. The warmth starts at your face, then this travels to
your arms and
all the way down to your fingertips. These sensations travel to the back
muscles and the
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shoulders. These sensations go to the chest and your belly muscles and you are
aware of
these muscles moving in and out with each slow breath. These sensations
continue down
to your legs, the warm feeling continues to travel down to your feet and you
are more
aware of the sand ,the water, and the warmth of the sun."
This example is merely one of several options offered to a user by the client
application. The biofeedback mechanisms may be used daily, weekly, or
according to any
other schedule determined by the patient or physician. These sessions improve
stress
reduction and management, and assist in treatment and reversal of
arteriosclerosis.
FIG. 7 is a flow diagram of a first biofeedback interaction that provides a
progressive relaxation technique. Steps of FIG. 7 may be implemented using
software
instructions as part of client application 15.
In block 702, client application 15 instructs the patient regarding viewing
the
display screen as the interaction occurs in subsequent steps. For example,
client
application 15 causes client system 14A to play an audio file that states,
"you may close
your eyes or leave them open, whichever you prefer." In block 704, the patient
is
prompted to select a relaxation scenario such as walking on the beach, walking
in the
forest, etc. The scenarios are selected to assist the patient in achieving
relaxation.
In block 706, the user attaches a monitoring device. For example, the user
attaches
a monitoring device that provides a blood pressure monitoring capability,
Doppler
vascular monitor, and pulse oxymeter. Alternatively, separate monitoring
devices that
perform similar functions may be attached.
In block 70~, one or more instructions are issued to the user. For example,
client
application 15 instructs the user to adopt slow breathing, and to concentrate
on air
movement through the respiratory tract. In block 710, one or more further
instructions are
issued. For example, client application 15 instructs the user to concentrate
on allowing
muscle tightness around the neck shoulders to loosen, and optionally may issue
one or
more further instructions. Concurrently, client application 15 displays
graphical images
and video information, and plays sound files that represent the selected
scenario. Thus,
the audible instructions and video display are coordinated to present a visual
and auditory
experience corresponding to the selected scenario, in a way that induces
relaxation.
Also concurrently, result data and other data representing vital signs of the
user
are displayed, as indicated in block 712 and block 714. For example, vital
sign data is
displayed in real time on the video display of client system 14A. In this
context, vital
signs include blood pressure, pulse, oxygen content, and vascular waveforms.
Thus, the
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user is able to see, in real time, responses and changes in the vital signs,
and correlate the
changes with the patient's level of relaxation.
The user also can use the process of FIG. 7 to induce a reverse effect for
purposes
of evaluation and observation. For example, in response to appropriate
instructions by
client application 15, the user may see how blood pressure, pulse, oxygen
content, and
vascular waveforms are altered during stressful conditions or thought
processes.
FIG. 8 is a flow diagram of a second biofeedback interaction that provides a
nutrition interaction.
In block 802, client application 15 causes client system 14A to display one or
more audiovisual programs relating to benefits of good nutrition. For example,
client
application 15 may generate a display of information that separates healthy
foods in
comparison to unhealthy foods, as shown by block 804. As indicated in block
806,
audiovisual programs about healthy foods may be coupled by video illustrations
on the
effects of the cardiovascular system in their reversal and treatment of
arteriosclerosis.
Similarly, as shown by block 808, audiovisual programs about unhealthy foods
may be
presented in association with audiovisual information about accelerated
formation of
plaque formation on the artery wall. In block 810, client application 15 may
provide
visualization exercises for the user to follow on how healthy foods benefit
better health
and fitness.
In block 812, the user is prompted to select whether to perform another
biofeedback interaction, such as the progressive relaxation biofeedback
interaction of
FIG. 7. If the user selects such an interaction, it is invoked or performed,
as shown by
block 816. In either case, improvement in user health occurs, as indicated by
block 814.
FIG. 9 is a flow diagram of a third biofeedback interaction that provides an
exercise
interaction.
In one embodiment, the process of FIG. 9 provides a biofeedback interaction in
the area of cardiovascular aerobic exercise, as shown by block 902. In
general, a user
follows illustrations generated by client application 15 on the effects of
aerobic exercise
on the cardiovascular system, and which show the benefits of aerobic exercise.
In block
904, the user attaches a monitoring device, or one or more separate monitoring
devices, as
in block 706 of FIG. 7.
In block 906, client application 1~5 prompts the user to select an exercise
type and
complexity. The user then participates in the selected or recommended
exercises using
equipment available to the user, and with the monitoring device attached to
the user. For
example, in one embodiment, the user may choose from among walking in place,
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performing hand grips, performing knee bends, performing modified squats,
performing
arm exercises, etc. Concurrently, data representing vital signs of the user
are displayed in
real time on the video display of client system 14A. In this context, vital
signs include
blood pressure, pulse, oxygen content, and vascular waveforms. Thus, the user
is able to
see, in real time, responses and changes in the vital signs, and correlate the
changes with
the patient's level of exercise.
In block 908, the user is prompted to select whether to perform another
biofeedback interaction, such as the progressive relaxation biofeedback
interaction of
FIG. 7. If the user selects such an interaction, it is invoked or performed,
as shown by
block 910. In either case, improvement in user health occurs, as indicated by
block 912.
FIG. 10A is a flow diagram of a fourth biofeedback interaction that addresses
effects of cardiovascular medications. In general, the biofeedback interaction
of FIG. 10A
may be used to monitor the effects of cardiovascular medications that may have
been
prescribed by a physician, as indicated by block 1002. Block 1002 also may
involve using
technical means to integrate the user's physician into the biofeedback
interaction so that
the physician can monitor changes in the user's physiology. For example, block
1002
may involve the user and physician concurrently using separate instances of
client
application 15, at client system 14A, 14B, respectively, to view real-time
patient
physiological data as cardiovascular medications are absorbed by the patient.
Alternatively, the process of FIG. 10A may be performed in a clinical setting,
enabling
direct physician monitoring.
In block 1004, the user attaches a monitoring device, or one or more separate
monitoring devices, as in block 706 of FIG. 7. Block 1004 may also involve
administering one or more medications to the patient and waiting for am
appropriate time
to enable the patient to begin to absorb the medications.
Concurrently, data generated by the monitoring device and representing vital
signs
of the user are displayed in real time on the video display of client system
14A. In this
context, vital signs include blood pressure, pulse, oxygen content, and
vascular
waveforms. Thus, the user is able to see, in real time, responses and changes
in the vital
signs as medication is taken, and correlate the changes with the patient's
level of
medication.
In block 1008, the user is prompted to select whether to perform another
biofeedback interaction, such as the progressive relaxation biofeedback
interaction of
FIG. 7. If the user selects such an interaction, it is invoked or performed,
as shown by
block 1010. This enables the user to see the benefits of stress reduction in
combination
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with medication interactions. In either case, improvement in user health
occurs, as
indicated by block 1012.
In still another biofeedback interaction, the user may compare data obtained
at one
point in treatment with similar data obtained at another point. This
interaction enables the
patient to perform a comparison, over a long-term follow-up period, of changes
in the
patient's vascular health. In particular, a user or physician may use such a
biofeedback
interaction to monitor the long-term beneficial changes that occurs with
behavioral .
modifications. Client application 15 measures waveform data obtained from the
Doppler
vascular monitor as part of monitoring device 12 to determine elasticity of
the artery,
which may be correlated with the amount of plaque formation on the artery
wall. The user
may perform periodic comparisons of such parameters in order to follow changes
in
vascular health.
FIG. l OB is a flow diagram of a fifth biofeedback interaction that relates to
physician review of data results. In block 1020, a patient reviews one or more
indications
for study with a physician. For example, prior clinical tests, laboratory
results, history
information, or other factors may identify indications such as hypertension or
high
cholesterol that need study. In block 1022, normal and abnormal changes are
illustrated.
Block 1022 may involve using a physician-specific version of client
application 15 to
display one or more audiovisual programs or graphical models of vascular
anatomy and
ftulction.
In block 1024, the physician attaches one or more physiological monitoring
devices and performs an evaluation of the patient. Concurrently, real-time
data gathered
from the monitoring devices is displayed by client application 15 using client
system 14B.
The data is uploaded, simultaneously or subsequently, to a data center that
stores the data
in association with a physician account or patient account for later analysis.
As shown in
block 1026, the data center receives, processes and returns result data to the
physician.
In block 1028, the physician reviews the result data with the patient and
records
one or more changes in the patient's health that have occurred over time. Such
recordation may occur in a traditional patient chart or using client
application 15 to enter
appropriate values. Concurrently, one or more graphs or audiovisual programs
relating to
changes in the patient's health are displayed. In this manner, the patient
experiences
biofeedback by visually seeing or audibly experiencing positive or negative
changes in
health. In block 1030, one or more recommendations of client application 15 or
of the
physician are reviewed with the patient, amd further follow-up may be
scheduled.
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4.0 IMPLEMENTATION MECHANISMS -- HARDWARE OVERVIEW
FIG. 11 is a block diagram that illustrates a computer system 1100 upon which
an
embodiment of the invention may be implemented. Computer system 1100 includes
a
bus 1102 or other communication mechanism for communicating information, and a
processor 1104 coupled with bus 1102 for processing information. Computer
system
1100 also includes a main memory 1106, such as a random access memory ("RAM")
or
other dynamic storage device, coupled to bus 1102 for storing information and
instructions to be executed by processor 1104. Main memory 1106 also may be
used for
storing temporary variables or other intermediate information during execution
of
instructions to be executed by processor 1104. Computer system 1100 further
includes a
read only memory ("ROM") 1108 or other static storage device coupled to bus
1102 for
storing static information and instructions for processor 1104. A storage
device 1110,
such as a magnetic disk or optical disk, is provided and coupled to bus 1102
for storing
information and instructions.
Computer system 1100 may be coupled via bus 1102 to a display 1112, such as a
cathode ray tube ("CRT"), for displaying information to a computer user. An
input
device 1114, including alphanumeric and other keys, is coupled to bus 1102 for
communicating information and cormnand selections to processor 1104. Another
type of
user input device'is cursor control 1116, such as a mouse, trackball, stylus,
or cursor
direction keys for communicating direction information and command selections
to
processor 1104 and for controlling cursor movement on display 1112. This input
device
typically has two degrees of freedom in two axes, a first axis (e.g., x) and a
second axis
(e.g., y), that allows the device to specify positions in a plane.
The invention is related to the use of computer system 1100 for digitally
signing
shared dynamic content. According to one embodiment of the invention,
digitally signing
shared dynamic content is provided by computer system 1100 in response to
processor
1104 executing one or more sequences of one or more instructions contained in
main
memory 1106. Such instructions may be read into main memory 1106 from another
computer-readable medium, such as storage device 1110. Execution of the
sequences of
instructions contained in main memory 1106 causes processor 1104 to perform
the
process steps described herein. In alternative embodiments, hard-wired
circuitry may be
used in place of or in combination with software instructions to implement the
invention.
Thus, embodiments of the invention are not limited to any specific combination
of
hardware circuitry and software.
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The term "computer-readable medium" as used herein refers to any medium that
participates in providing instructions to processor 1104 for execution. Such a
mediiun
may take many forms, including but not limited to, non-volatile media,
volatile media,
and transmission media. Non-volatile media includes, for example, optical or
magnetic
disks, such as storage device 11 I0. Volatile media includes dynamic memory,
such as
main memory 1106. Transmission media includes coaxial cables, copper wire and
fiber
optics, including the wires that comprise bus 1102. Transmission media can
also take the
form of acoustic or light waves, such as those generated during radio wave and
infrared
data communications.
Common forms of computer-readable media include, for example, a floppy disk, a
flexible disk, hard disk, magnetic tape, or any other magnetic medium, a CD-
ROM, any
other optical medium, punchcards, papertape, any other physical medium with
patterns of
holes, a RAM, a PROM, and EPROM, a FLASH-EPROM, any other memory chip or
cartridge, a carrier wave as described hereinafter, or any other medium from
which a
computer can read.
Various forms of computer readable media may be involved in carrying one or
more sequences of one or more instructions to processor 1104 for execution.
For
example, the instructions may initially be carried on a magnetic disk of a
remote
computer. The remote computer can load the instructions into its dynamic
memory and
send the instructions over a telephone line using a modem. A modem local to
computer
system 1100 can receive the data on the telephone line and use an infrared
transmitter to
convert the data to an infrared signal. An infrared detector can receive the
data carned in
the infrared signal and appropriate circuitry can place the data on bus 1102.
Bus 1102
carries the data to main memory 1106, from which processor 1104 retrieves and
executes
the instructions. The instructions received by main memory 1106 may optionally
be
stored on storage device 1110 either before or after execution by processor
1104.
Computer system 1100 also includes a communication interface 1118 coupled to
bus I 102. Communication interface 1118 provides a two-way data communication
coupling to a network link 1120 that is connected to a local network 1122. For
example,
corrununication interface 1118 may be an integrated services digital network
("ISDN")
card or a modem to provide a data communication connection to a corresponding
type of
telephone line. As another example, communication interface 1118 may be a
local area
network ("LAN") card to provide a data communication connection to a
compatible
LAN. Wireless links may also be implemented. In any such implementation,
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communication interface 1118 sends and receives electrical, electromagnetic or
optical
signals that carry digital data streams representing various types of
information.
Network link 1120 typically provides data communication through one or more
networks to other data devices. For example, network linlc 1120 may provide a
connection through local network 1122 to a host computer 1124 or to data
equipment
operated by an Internet Service Provider ("ISP") 1126. ISP 1126 in turn
provides data
communication services through the worldwide packet data communication network
now
commonly referred to as the "Internet" 1128. Local network 1122 and Internet
1128 both
use electrical, electromagnetic or optical signals that carry digital data
streams. The
signals through the various networks and the signals on network link 1120 and
through
communication interface 1118, which carry the digital data to and from
computer system
1100, are exemplary forms of carrier waves transporting the information.
Computer system 1100 can send messages and receive data, including program
code, through the network(s), network link 1120 and communication interface
1118. In
the Internet example, a server 1130 might transmit a requested code for an
application
program through Internet 1128, ISP 1126, local network 1122 and communication
interface 1118. In accordance with the invention, one such downloaded
application
provides for digitally signing shared dyna.~nic content as described herein.
The received code may be executed by processor 1104 as it is received, and/or
stored in storage device 1110, or other non-volatile storage for later
execution. In this
manner, computer system 1100 may obtain application code in the form of a
Garner wave.
5.0 EXTENSIONS AND ALTERNATIVES
In the foregoing specification, the invention has been described with
reference to
specific embodiments thereof. It will, however, be evident that various
modifications and
changes may be made thereto without departing from the broader spirit and
scope of the
invention. For example, embodiments are applicable to treatment of vascular
disease,
hypertension, elevated cholesterol, and diabetes, and are useful in achieving
stress
reduction, addressing weight problems, smoking cessation, and improving
personal
lifestyle choices and habits. The specification and drawings are, accordingly,
to be
regarded in an illustrative rather than a restrictive sense.
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