U.S. patent application number 13/222920 was filed with the patent office on 2011-12-29 for multipurpose host system for invasive cardiovascular diagnostic measurement acquisition including an enhanced dynamically configured graphical display.
This patent application is currently assigned to VOLCANO CORPORATION. Invention is credited to Howard David Alpert, Bruce Richard Chapman, William Russell Kanz.
Application Number | 20110319773 13/222920 |
Document ID | / |
Family ID | 39887800 |
Filed Date | 2011-12-29 |
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United States Patent
Application |
20110319773 |
Kind Code |
A1 |
Kanz; William Russell ; et
al. |
December 29, 2011 |
Multipurpose Host System for Invasive Cardiovascular Diagnostic
Measurement Acquisition Including an Enhanced Dynamically
Configured Graphical Display
Abstract
The present invention provides a multipurpose host system for
processing and displaying invasive cardiovascular diagnostic
measurement data. The system includes a an external input signal
bus interface. The bus interface receives data arising from
cardiovascular diagnostic measurement sensors. Measurement
processing components receive data from particular sensor types.
Based on the received data, the processing components render
diagnostic measurement parameter values. A multi-mode graphical
user interface includes display components corresponding to data
received from particular sensor types. The user interface provides
recommended action prompts that guide a user through a series of
actions.
Inventors: |
Kanz; William Russell;
(Woodinville, WA) ; Chapman; Bruce Richard;
(Folsom, CA) ; Alpert; Howard David; (El Dorado
Hills, CA) |
Assignee: |
VOLCANO CORPORATION
San Diego
CA
|
Family ID: |
39887800 |
Appl. No.: |
13/222920 |
Filed: |
August 31, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11870308 |
Oct 10, 2007 |
8029447 |
|
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13222920 |
|
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60828961 |
Oct 10, 2006 |
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Current U.S.
Class: |
600/486 ;
715/771 |
Current CPC
Class: |
A61B 5/0215 20130101;
A61B 5/7435 20130101; A61B 5/0006 20130101 |
Class at
Publication: |
600/486 ;
715/771 |
International
Class: |
A61B 5/0215 20060101
A61B005/0215; G06F 3/048 20060101 G06F003/048 |
Claims
1-18. (canceled)
19. A system for cardiovascular diagnostic measurement acquisition
and display, the system comprising: an interface for receiving data
arising from one or more cardiovascular diagnostic measurement
sensors attached to a flexible elongate member positioned within a
vessel, the data being representative of at least one of pressure
within the vessel and flow within the vessel; at least one
processing component in communication with the interface and
configured to receive data from the one or more cardiovascular
diagnostic measurement sensors attached to the flexible elongate
member and rendering diagnostic measurement parameter values of at
least one of the pressure within the vessel and the flow within the
vessel according to the received data; and a graphical user
interface including display components corresponding to data output
rendered by the at least one processing component, the user
interface simultaneously displaying a plurality of buttons
associated with actions of the one or more cardiovascular
diagnostic measurement sensors attached to the flexible elongate
member, wherein the simultaneously displayed plurality of buttons
associated with the actions of the one or more cardiovascular
diagnostic measurement sensors are based on the sensor type for
each of the one or more cardiovascular diagnostic measurement
sensors and wherein the user interface provides recommended action
prompts to a user automatically based on the data received from the
one or more cardiovascular diagnostic measurement sensors attached
to the flexible elongate member, the recommended action prompts
providing visual indicators that guide a user through a series of
actions by visually accentuating, in series, the plurality of
buttons of the user interface associated with the actions of the
one or more cardiovascular diagnostic measurement sensors attached
to the flexible elongate member.
20. The system of claim 19, wherein the system determines a sensor
type for each of the one or more cardiovascular diagnostic
measurement sensors connected to the system and generates the
plurality of buttons based on the determined sensor type.
21. The system of claim 19, wherein the user interface visually
accentuates a particular button of the plurality of simultaneously
displayed buttons associated with a particular action of the series
of actions by displaying at least one other button of the plurality
of simultaneously displayed buttons in a way indicating that
execution of the action associated with the at least one other
button is prevented.
22. The system of claim 19, wherein the user interface displays at
least one diagnostic measurement user interface based on data
generated by the one or more cardiovascular diagnostic measurement
sensors attached to a flexible elongate member and in communication
with the interface.
23. The system of claim 22, wherein the user interface displays a
diagnostic measurement user interface associated with a sensor type
only when such a sensor type is attached to the flexible elongate
member and in communication with the interface.
24. The system of claim 19, wherein the one or more cardiovascular
diagnostic measurement sensors includes a blood pressure
sensor.
25. The system of claim 19, wherein the one or more cardiovascular
diagnostic measurement sensors includes a blood velocity
sensor.
26. The system of claim 19, wherein the one or more cardiovascular
diagnostic measurement sensors includes a blood pressure sensor and
a blood velocity sensor.
27. The system of claim 26, wherein the user interface displays
user interfaces based on data generated from both the blood
pressure sensor and the blood velocity sensor.
28. The system of claim 19, further comprising a record module
configured to record data rendered by the one or more
cardiovascular diagnostic measurement sensors.
29. The system of claim 28, further comprising a playback module
for viewing the data recorded by the record module.
30. A user interface for cardiovascular diagnostic measurement
acquisition and display, the interface comprising: a settings
module for viewing and editing sensor calibration data for one or
more sensors attached to a flexible elongate member and configured
for positioning within a vessel of a patient to monitor at least
one of a pressure within the vessel and a flow within the vessel; a
viewing module for viewing, in real time, data rendered by the one
or more sensors while the flexible elongate member is positioned
within the vessel of the patient, the viewing module automatically
displaying a plurality of action buttons pertinent to the one or
more sensors attached to the flexible elongate member
simultaneously and automatically indicating recommended actions to
a user of the system based on data received from the one or more
sensors, wherein the recommended actions comprise a plurality of
actions to be performed in series to obtain data from the one or
more sensors representative of at least one of the pressure within
the vessel and the flow within the vessel, and wherein the
recommended actions are automatically indicated to the user in
series by visually accentuating one or more of the simultaneously
displayed plurality of action buttons of the user interface
associated with performing each of the recommended actions, and
wherein the viewing module determines the plurality of action
buttons pertinent to the sensors based on the types of sensors
attached to the flexible elongate member.
31. The user interface of claim 30, wherein the one or more sensors
attached to the flexible elongate member includes a cardiovascular
diagnostic measurement sensor.
32. The user interface of claim 31, wherein the cardiovascular
diagnostic measurement sensor is a blood pressure sensor.
33. The user interface of claim 31, wherein the cardiovascular
diagnostic measurement sensor is a blood velocity sensor.
34. The user interface of claim 31, wherein the one or more sensors
attached to the flexible elongate member include a blood pressure
sensor and a blood velocity sensor.
35. The user interface of claim 34, wherein the viewing module
displays user interfaces based on data generated from both the
blood pressure sensor and the blood velocity sensor.
36. The user interface of claim 30, wherein the viewing module
determines the plurality of action buttons pertinent to the sensors
based on a resistance value on a line associated with each of the
one or more sensors.
37. The user interface of claim 30, wherein the setting module
obtains calibration parameters for each of the one or more sensors
from memory associated with each of the one or more sensors.
38. The user interface of claim 30, wherein the viewing module
visually accentuates the particular button of the plurality of
simultaneously displayed buttons associated with the particular
action of the series of actions by displaying the particular button
in a way indicating that execution of the particular action
associated with the particular button should be performed.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims priority to Kanz (et al) U.S.
Provisional Application Ser. No. 60/828,961, entitled "MULTIPURPOSE
HOST SYSTEM FOR INVASIVE CARDIOVASCULAR DIAGNOSTIC MEASUREMENT
ACQUISITION INCLUDING AN ENHANCED DYNAMICALLY CONFIGURED GRAPHICAL
DISPLAY", the contents of which are expressly incorporated by
reference in their entirety, including any references contained
therein.
AREA OF THE INVENTION
[0002] The present invention generally relates to the area of
diagnostic medical equipment, and more particularly to diagnostic
devices for identifying and/or verifying efficacy of treatment of
problematic blockages within coronary arteries by means of sensors
mounted upon the end of a flexible elongate member such as a guide
wire or a catheter.
BACKGROUND OF THE INVENTION
[0003] Innovations in diagnosing and verifying the level of success
of treatment of cardiovascular disease have migrated from external
imaging processes to internal, catheterization-based, diagnostic
processes. Diagnosis of cardiovascular disease has been performed
through angiogram imaging wherein a radiopaque dye is injected into
a vasculature and a live x-ray image is taken of the portions of
the cardiovascular system of interest. Magnetic resonance imaging
(MRI) has also been utilized to non-invasively detect
cardiovascular disease. Diagnostic equipment and processes also
have been developed for diagnosing vasculature blockages and other
vasculature disease by means of ultra-miniature sensors placed upon
a distal end of a flexible elongate member such as a catheter, or a
guide wire used for catheterization procedures.
[0004] One such ultra-miniature sensor device is a pressure sensor
mounted upon the distal end of a guide wire. An example of such a
pressure sensor is provided in Corl et al. U.S. Pat. No. 6,106,476,
the teachings of which are expressly incorporated herein by
reference in their entirety. Such intravascular pressure sensor
measures blood pressure at various points within the vasculature to
facilitate locating and determining the severity of stenoses or
other disrupters of blood flow within the vessels of the human
body. Such devices are presently used to determine the need to
perform an angioplasty procedure by measuring blood pressure within
a vessel at multiple locations, including both upstream and
downstream of a stenosis and measuring a pressure difference that
indicates the severity of a partial blockage of the vessel.
[0005] In particular, a guide wire mounted pressure sensor is
utilized to calculate fractional flow reserve (or "FFR"). In the
coronary arteries, FFR is the maximum myocardial flow in the
presence of stenosis divided by the normal maximum myocardial flow.
This ratio is approximately equal to the mean hyperemic (i.e.,
dilated vessel) distal coronary pressure Pd divided by the mean
arterial pressure Pa. Pd is measured with a pressure sensor mounted
upon a distal portion of guide wire or other flexible elongate
member after administering a hyperemic agent into the blood vessel
causing it to dilate. Pa is measured using a variety of techniques
in areas proximal of the stenosis, for example, in the aorta.
[0006] FFR provides a convenient, cost-effective way to assess the
severity of coronary and peripheral lesions, especially
intermediate lesions. FFR provides an index of stenosis severity
that allows rapid determination of whether an arterial blockage is
significant enough to limit blood flow within the artery, thereby
requiring treatment. The normal value of FFR is about 1.0. Values
less than about 0.75 are deemed significant and require treatment.
Treatment options include angioplasty and stenting.
[0007] Another such known ultra-miniature sensor device is a
Doppler blood flow velocity sensor mounted upon the end of a guide
wire. Such device emits ultrasonic waves along the axis of a blood
vessel and observes a Doppler-shift in reflected echo waves to
determine an approximation of instantaneous blood flow velocity. A
Doppler transducer is shown in Corl et al. U.S. Pat. No. 6,106,476
on a guide wire that also carries a pressure transducer. Such
devices are presently used to determine the success of a treatment
to lessen the severity of a vessel blockage.
[0008] In particular, a Doppler transducer sensor is utilized to
measure Coronary Flow Reserve (or "CFR"). CFR is a measure for
determining whether a stenosis is functionally significant after
treatment (e.g., post-angioplasty). CFR comprises a ratio of the
hyperemic average peak velocity of blood flow to the baseline
(resting) average peak velocity. Instantaneous peak velocity (IPV)
is the peak observed velocity for an instantaneous Doppler spectrum
provided by a Doppler transducer. An exemplary method of
calculating an average peak velocity (APV) comprises averaging a
set of IPV's over a cardiac cycle.
[0009] A known technique for determining whether an angioplasty was
effective was to perform angioplasty, wait a few days, then perform
thalium scintigraphy (imaging). If the angioplasty procedure was
not effective, then re-intervention was performed and the lesion
was again treated via angioplasty. On the other hand, using CFR, a
flow measurement is taken immediately after angioplasty or
stenting. The flow measurement is utilized to determine whether
adequate flow has been restored to the vessel. If not, the balloon
is inflated without the need for secondary re-intervention. A
normal CFR is greater than about 2 and indicates that a lesion is
not significant. Lower values may require additional intervention.
In addition to being used post-treatment to determine the efficacy
of treatment, CFR may be measured prior to treatment to determine
if treatment is required.
[0010] A guide wire combination device, comprising a pressure
sensor and a flow sensor having substantially different operational
characteristics, was disclosed in the Corl et al. U.S. Pat. No.
6,106,476. While it has been proposed within the Corl et al. U.S.
Pat. No. 6,106,476 to combine pressure and flow sensors on a single
flexible elongate member, the prior art does not address how such a
combination sensor is coupled to consoles that display an output
corresponding to the signals provided by the flexible elongate
member corresponding to the sensed pressure and flow within a
vessel. Indeed, in known systems special-purpose monitors having
static display interfaces that display a static set of parameters
corresponding to a particular fixed set of diagnostic measurements
(e.g., an aortic pressure and a pressure taken from a location
proximate a stenosis). Thus, one type of monitor is utilized to
process and display sensed pressure within a blood vessel. Another
type of monitor provides output relating to blood flow within a
vessel. As new intravascular diagnostic devices are developed, yet
other special-purpose monitors/consoles are developed to display to
a physician the sensed parameters.
[0011] There is substantial interest in simplifying every aspect of
the operating room to reduce the incidence of errors. As one can
imagine, the aforementioned intravascular pressure sensors are
utilized in operating room environments including many types of
sensors and equipment for diagnosing and treating cardiovascular
disease. Clearly, the room for error is very limited when
performing such activities. Notwithstanding the interest to keep
equipment and operations simple, there exists a variety of
different sensors that are potentially inserted within a human
vasculature to diagnose arterial disease (e.g., blockages) and/or
monitor vital signs during a medical procedure. The approach taken
in the field of interventional cardiac imaging has been to provide
multiple, special-purpose monitor consoles. Each monitor type is
linked to a particular type of sensor device.
[0012] In a known prior intravascular pressure
sensor-to-physiological monitor interface arrangement, marketed by
JOMED Inc. of Rancho Cordova, Calif., a physiology monitor receives
and displays, on a permanently configured display interface, a set
of pressure values corresponding to two distinct pressure signals
that are received by the monitor. A first pressure signal is
provided by an aortic pressure sensor, and a second pressure signal
corresponds to a pressure sensed by a distally mounted solid-state
pressure sensor mounted upon a guide wire. The display interface of
the monitor is permanently configured to output parameter values
corresponding to those two signals. Thus, if display of, for
example, a flow signal value is desired, then a separate monitor,
such as JOMED Inc.'s FloMap, is used. More recently, a multipurpose
user interface application/system is provided. An example of such a
system is described in Alpert et al. U.S. Pat. No. 7,134,994
SUMMARY OF THE INVENTION
[0013] The present invention provides a multipurpose host system
for processing and displaying invasive cardiovascular diagnostic
measurement data. The system includes an external input signal bus
interface. The bus interface receives data arising from
cardiovascular diagnostic measurement sensors. Measurement
processing components receive data from particular sensor types.
Based on the received data, the processing components render
diagnostic measurement parameter values. A multi-mode graphical
user interface includes display components corresponding to data
received from particular sensor types. The user interface provides
recommended action prompts that guide a user through a series of
actions. The measurement sensors, by way of example, include a
blood pressure processing sensor and a blood velocity sensor. The
user interface provides recommended action prompts, by way of
example, by altering the appearance of graphical elements on the
display.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] While the appended claims set forth the features of the
present invention with particularity, the invention, together with
its objects and advantages, may be best understood from the
following detailed description taken in conjunction with the
accompanying drawings of which:
[0015] FIG. 1 is a schematic drawing depicting a system for
conducting invasive cardiovascular diagnoses including an external
input signal interface for receiving diagnostic parameter values of
multiple types and a multimode graphical user interface for
presenting the values according to a user-selected one of the
multiple display modes;
[0016] FIG. 2 depicts an exemplary graphical user interface for a
system upon which signals rendered by invasive cardiovascular
sensors are displayed;
[0017] FIG. 3 depicts an exemplary graphical user interface for
configuring system settings for the system;
[0018] FIG. 4 depicts an exemplary graphical user interface for
configuring pressure settings for the system;
[0019] FIG. 5 depicts an exemplary graphical user interface for
configuring flow settings for the system;
[0020] FIG. 6 depicts an exemplary graphical user interface for
configuring service settings for the system;
[0021] FIG. 7 depicts an exemplary graphical user interface for
configuring research settings for the system;
[0022] FIG. 8 depicts an exemplary graphical user interface for
configuring factory settings for the system;
[0023] FIG. 9 depicts an exemplary graphical user interface for
entering patient data into the system;
[0024] FIG. 10 depicts an exemplary graphical user interface for
obtaining live data rendered by invasive cardiovascular
sensors;
[0025] FIG. 11 illustrates an exemplary graphical user interface
for determining the peak hyperemia;
[0026] FIG. 12 illustrates an exemplary graphical user interface
displaying flow and pressure data rendered by invasive
cardiovascular sensors;
[0027] FIG. 13 illustrates an exemplary graphical user interface
displaying flow data rendered by invasive cardiovascular
sensors;
[0028] FIG. 14 illustrates an exemplary graphical user interface
displaying recorded pressure data rendered by invasive
cardiovascular sensors;
[0029] FIG. 15 illustrates an exemplary graphical user interface
displaying recorded pressure and flow data rendered by invasive
cardiovascular sensors; and
[0030] FIG. 16 is a flowchart summarizing a set of steps for
displaying appropriate user interface screens based on the
cardiovascular sensor connected to the system.
DETAILED DESCRIPTION OF THE DRAWINGS
[0031] A multipurpose host system for invasive cardiovascular
diagnostic measurement acquisition and display presents multiple
user display interfaces. Each of the display interfaces corresponds
to a particular purpose for which the multipurpose host is
currently configured based, for example, upon one or more sensor
devices communicatively coupled to its external signal interface.
The host system is used, for example, in conjunction with
interventional cardiology, e.g., angiography, or interventional
procedures, e.g., angioplasty, to evaluate the hemodynamic status
of an arterial blockage. The present system includes an enhanced
user interface that guides users through various tasks. In some
embodiments the system automatically displays appropriate user
interfaces based on the sensor connected to the host system.
[0032] With reference to FIG. 1, a multipurpose host system 100 is,
by way of example, a personal computer architecture-based system
for assessing real-time invasive cardiovascular parameters from
within a blood vessel (e.g., blood pressure and flow measurements).
An example of such a host system is provided in Alpert et al. U.S.
Pat. No. 7,134,994, the teachings of which are expressly
incorporated herein by reference in their entirety. The
multipurpose host processes input signals from multiple
micro-miniature guide wire-mounted sensors (e.g., Doppler and
pressure transducers) to produce real-time measurements, display
various waveforms and derived parameters, and output high-level
voltages proportional to calculated parameter values. The devices
that supply the various data input signals are represented by
pressure input 102, velocity flow input 104, volume flow 106, and
temperature input 108. In an embodiment of the invention, the
devices that provide the input to the host system 110 are presently
used in existing, special-purpose processing boxes. This set is
exemplary, as those skilled in the art will readily appreciate in
view of this disclosure that alternative systems advantageously
receive and process such diagnostic inputs as pH, ultrasound and
light-based cross-sectional images of a vessel, biochemical
markers, light spectrometry for tissue characterization, etc. It is
further noted that the displayed output of the host system 100 is
not limited to producing the measured parameters. Rather, the
various modes of the host system 100 are capable of synthesizing
generalized measures of physiological status (e.g., whether a
blockage is severe and needs treatment) based upon the input
parameter values.
[0033] The host system 100 operates in a plurality of modes, and
each mode includes its own distinct graphical interface (rendered
on graphical output display 110) and input parameter values
(provided via a peripheral component interconnect (PCI) card 112)
corresponding to particular sensor types. The PCI card 112
includes, by way of example, a digital signal processor (DSP) that
samples data provided by the communicatively coupled input sensors
and processes the sampled data to render digital data in a format
expected by higher level components of the host system 100.
Exemplary processes performed by the DSP include: A/D and D/A
conversions, FFTs, level shifting, normalizing, and scaling. After
processing the data, it is stored in a dual port RAM accessed, via
the PCI bus of the host 100, by higher level application processes
executing on the host system 100.
[0034] In the exemplary embodiment, input sensor types driving the
output displays include pressure, flow, and temperature sensors
mounted upon a flexible elongate member including combinations
thereof placed, for example, upon a single guide wire or catheter.
In fact, the flexible module-based architecture of the exemplary
host system 110, which supports simultaneous display of multiple
distinct types of input signals on a single graphical user
interface, is particularly well suited for such combination devices
since their output can be simultaneously monitored on a single
interface even though modules that process the sensor inputs
execute independently within the host system 100.
[0035] The exemplary host system 100 operates in pressure, flow,
and combination (pressure/flow) modes. Though not essential to the
invention, operation of each mode is preferably independent of the
other modes, and each diagnostic display mode is driven by a
designated set of parameter generation modules associated with
particular input signals received by the host system from a
communicatively coupled sensor. The pressure mode provides the user
with a selection of calculated/derived parameters such as for
example: proximal-distal pressure gradient, distal/proximal
pressure ratio, normalized pressure ratio, and fractional flow
reserve (normalized pressure ratio under hyperemic conditions). In
an exemplary embodiment, the flow mode is divided into three
operational modes: peripheral, coronary, and research. The
peripheral mode acquires measurements in the cerebral or peripheral
vasculature. The coronary mode acquires measurements in the
coronary arteries. The research mode provides a superset of
peripheral and coronary modes plus additional parameters that may
be of interest in a clinical research environment. The combination
mode allows parameters associated with pressure and flow modes to
be displayed simultaneously on a single graphical display.
[0036] In the illustrative embodiment of the invention, the
graphical display interface 110 depicts calculated pressure and
flow information on a strip chart graph on a graphical user
interface display. The current values are, for example, displayed
numerically as well. The graph scrolls as new information is
calculated and added. A graphically displayed control enables a
user to freeze the scrolling graphs and scroll backwards to view
previously displayed portions of the scrolling graph. Additional
display methods and techniques will be apparent to those skilled in
the art.
[0037] In the illustrative example, the host system 100 embodies an
extensible, component-based architecture, and thus the host system
100 supports a virtually limitless number of operating modes for
processing and rendering graphical display output corresponding to
an extensible set of input signals provided by sensors measuring a
variety of types and combinations thereof. The host system 100 is
modularized to support receiving and processing signals in a
variety of formats from a variety of instruments. In a particular
exemplary embodiment of the invention, the host system 100 relies
on transducers and external diagnostic instrumentation to: (1)
process the raw sensor information rendered by transducers/sensors
inserted within a patient and (2) provide the information to the
host 100 in particular digital or analog formats. The host system
100's capabilities are extendable, by way of example through
enhancements to a currently installed peripheral component
interconnect (PCI) board 110 or the addition of new PCI boards, to
include additional signal processing capabilities. In an exemplary
embodiment, transducers on the guide wire (patient isolated)
provide low-level signals for blood velocity, flow, and pressure. A
standard external pressure transducer (patient isolated) may be
integrated with the host system to provide low-level aortic
pressure. A high-level ECG signal input to the host provides
synchronization for calculations (not patient isolated).
[0038] The interface of the host system 100 comprises a number of
additional interfaces supporting the transfer and storage of
information relating to the operation of the host system. Data
storage device 114, for example, a CD-RW or a DVD-RW drive, is
utilized to upload new software and store patient data processed
and displayed during a diagnostic/treatment procedure. A network
interface 116 provides remote access for performing functions
similar to those provided by the data storage device 114. An audio
input 118 enables annotation of input records by a user. A printer
120 facilitates printing out labels and/or compiled data from a
diagnostic/treatment procedure. The set of peripheral/interface
components identified in FIG. 1 is exemplary. As those skilled in
the art will readily appreciate there exist a vast variety of I/O
devices that can be advantageously incorporated into the host
system 100 to enhance its utility. Furthermore, the above-described
multipurpose host system architecture is intended to be exemplary
and does not limit the broad range of system environments wherein
the user interface application described herein below is
potentially incorporated.
[0039] Having described the peripheral components and external
interfaces of an exemplary host system 100, attention is now
directed to a user interface incorporated into the exemplary
multipurpose host for carrying out a variety of
diagnostic/treatment procedures. The illustrative sets of user
interfaces support a variety of interactive sequences of actions
associated with the variety of sensors/devices connectable to the
host system 100. The user interface sets are configured to
facilitate a system-directed sequence of actions to acquire patient
data for particular diagnostic procedures.
[0040] FIG. 2 depicts an exemplary graphical user interface 85 of
graphical display 110. The interface 85 provides a user with
information tabs to input Setup information 5 and Patient
information 10. Additionally, the user can view Live 15 and
recorded 20 sensor information. In alternative embodiments of the
invention, Setup 5 information is shown as a Settings information
tab. The Setup 5 or Settings tab contains six sub-tabs that provide
setup or settings information for the system, pressure sensor, flow
sensor, service, research and factory information. Settings in the
sub-tabs are persistent from session to session and patient to
patient. Further, information in the Service, Research, and Factory
sub-tabs are password protected.
[0041] FIG. 3 illustrates an exemplary Systems sub-tab 22 of the
Settings tab 5. The Systems sub-tab includes, but is not limited
to, an identification string 23, touch screen volume 24, and
language selection 26, time/date 28, test label printer 30,
regional settings 32, touch screen calibration 34, ECG Gain 36,
Hardware Reset 38, Safety Shutdown Reset 40, Demo Mode 42, Search
Mode selection 44, Display after Search selection 46 and ECG Scale
selection 48. The system allows a user to select the information
shown on the display interfaces in several different languages 26.
Test Label Printer 30 allows a user to print a pre-configured label
for diagnostics. Regional settings 32 allow a user to select a
format style for the data present on the display interfaces. ECG
Gain 36 allows a user to select a gain corresponding to the signal
level. Hardware Reset 38 resets the DSP of the system. Safety
Shutdown Reset 40 resets the hardware after the safety shutdown
feature has been triggered. Demo Mode 42 allows a user to select a
system demonstration mode. The Display after Search selection 46
allows the user to automatically freeze after a peak timeout or
continue running after a peak timeout.
[0042] FIG. 4 illustrates an exemplary Pressure sub-tab 48 of the
Settings tab 5. The exemplary Pressure sub-tab 48 includes, Aortic
input 50, Aortic Input Zero selection 52, Aortic Output Offset 54,
Venous Input Preset 56, Venous Input Assumed Value 58, Distal
Output Offset 60, Distal Input 62, MAP Period Beats 64, Cardiac
Cycle Detection 66, ECG Trace Display Waveform selection 68, Venous
Display Waveform selection 70, Gradient 72, Aortic Filter 74,
Distal Filter 76, Output References Aortic High Level 78, Aortic
Low Level 80, Distal High Level 82, and Distal Low Level 84. The
ECG Trace Display Waveform selection 68 controls the display of the
Heart Rate value on the Live and Playback Tab screens (see, e.g.,
FIGS. 2, 14, and 15). If the ECG waveform is selected for display
68, the Heart Rate value on the Live Tab Display Screen (FIG. 2) is
displayed, otherwise, the Heart Rate value is not shown on the Live
Tab Display or the Playback screens.
[0043] The selection of the Venous Display Waveform selection 70
controls the display of the Pv value on the Live Tab Display Screen
(FIG. 2) when configured for pressure or combo modes. If the Venous
waveform 70 is selected for display on the Live Tab Display Screen
(FIG. 2), the Pv value is displayed on the Live Tab Display Screen.
Otherwise, the Pv value is not shown on the Live Tab Display or the
Playback screens.
[0044] FIG. 5 illustrates an exemplary Flow sub-tab 86 of the
Settings tab 5. The exemplary Flow sub-tab 86 includes, but is not
limited to, Zero Offset selection 88, Flow Direction selection 90,
Trend selection including clear 94, Timebase scale 96, and Trend
select 98, Output Reference APV 101, Output Reference IPV 103, APV
Period select 105, IPV/APV Scale Factor selection 107, Wall Filter
selection 109, Audio Volume adjustment 111, Audio Balance
adjustment 113, IPV Threshold selection 115, Display Threshold
selection 117, ECG Display waveform 119, Proximal Display waveform
121 and DSVR selection 123. If the DSVR 123 is selected "On", the
value shall appear on the Live and Playback displays, further
described hereinafter.
[0045] FIG. 6 illustrates an exemplary Service Setup sub-tab 124 of
the Settings tab 5. The exemplary Service sub-tab 124 includes, but
is not limited to, Diagnostics Start 126, Exit Service Mode 128,
Display all Messages 130, Directory 132, Output Calibration
settings 134, Input Calibration settings 136, Restore Default
Configuration 138, Abort Self Test 140, and Debug Window 142. The
Service Setup sub-tab 124 allows users to monitor, test and
diagnose issues with the system.
[0046] FIG. 7 illustrates an exemplary Research sub-tab 144 of the
Settings tab 5. The exemplary Research sub-tab 144 includes, but is
not limited to, High level input 1 146, High level input 2 148, PRF
150, Range Gates Width 152, Transmit Burst Width 154, Gate Depth
156, Transmit Voltage 158, IPV Tracking 160, Data Logging 162, Flow
Data Output 164 and Parameter Display 166. The exemplary Research
sub-tab 144 allows users to set parameters of the system.
Similarly, the Factory sub-tab 168 (FIG. 8) allows users to alter
parameters of the system typically configured by the system
manufacturer. Exemplary Settings include, Output Calibration 170,
Input Calibration 172, Display all messages 174, and Display panels
176 and 178.
[0047] FIG. 9 illustrates an exemplary Patient tab 10. The
exemplary Patient tab 10 includes fields for Last Name 180, First
Name 182, Middle Initial 184, Gender 186, Patient ID 188, Physician
190 and Date of Birth 192. Inputs are also provided to create a New
Patient 194, Select a Physician 196, Save a Patient Study 198 and
Recall a Patient Study 200. The Patient tab allows users to manage
individual patient files and track patient data.
[0048] After a user inputs the optional Setup or Settings
information (FIG. 3-FIG. 8) and Patient information (FIG. 9), Live
patient monitoring data may be viewed on the graphical user
interface. Referring to FIG. 2, after entering the option Setup
data on sub-tab 5 and Patient data on sub-tab 10, the user may
begin viewing data on the Live sub-tab 15. FIG. 2 represents an
exemplary Live display for pressure data. In this example, a Zero
setup has already been performed. The interface displays a message
202 notifying the user that the Zero setup has been completed.
Inputs on the Live sub-tab 15 (FIG. 10) displaying pressure data
include Freeze 204, Zero 206, Norm 208, Peak 210, Rec 212 and
Options 214. Freeze 204 allows the user to freeze the chart
interface. When the chart interface is not frozen, live data
scrolls across the interface. Zero 206 calibrates the zero point
aortic or proximal pressure wire. Norm 208 normalizes the distal
pressure wire to the aortic pressure. Rec 212 turns on the data
recording function. Options 214 allows the user to enter system
parameters.
[0049] The Live sub-tab 15 enters Pressure mode when only a
pressure wire is connected to the system. The screen displays data
variables on the left, graph in the middle, and user buttons on the
right.
[0050] In accordance with an illustrative example, the Live sub-tab
15 includes a wizard driven system to guide a user through
configuring and analyzing patient data. The system indicates the
next recommended action the user should perform. The system can
indicate the next recommended action in any method. For example,
the next action can appear as a different color on the screen or
can appear in bold text. In the illustrated embodiment, the next
recommended action appears highlighted in green, and no other
control on the screen will have the green color at the same time.
However, any appropriate method of indicating the next recommended
action (or multiple actions in the event that more than one
sequence of actions is available from a currently displayed user
interface) can be used. For example, in FIG. 2, the next recommend
action is Norm 208. Therefore Norm 208 appears green on the screen.
After viewing the screen, the user knows that the wizard driven
system recommends performing the Norm 208 action.
[0051] Furthermore, other appearance/user interface characteristics
are used to prevent a user from initiating actions. For example,
the Peak 210 step should not be performed until the Norm 208 step
is completed. Therefore, Peak 210 appears faded on the screen,
indicating to the user that it is not appropriate to perform the
Peak 210 step.
[0052] After performing the Norm 208 step indicated in FIG. 2, the
system recommends performing the Peak 210 step. FIG. 10 indicates
that the Peak 210 step should be performed by highlighting Peak 210
in green. The user interface illustrated in FIG. 10 displays Live
pressure data. After the user enters the Peak 210 mode, the peak
hyperemia can be found. FIG. 11 illustrates an exemplary graphical
user interface for determining the peak hyperemia. While
determining the peak hyperemia, the interface is controlled by the
Display after Search 46 control (FIG. 3).
[0053] The exemplary Peak interface (FIG. 11) includes Run 216
which starts and stops the chart scrolling. Print 218 prints the
screen. The left cursor 220 moves the data cursor 230 left. The
right cursor 222 moves the data cursor 230 right. Rec/Stop 226
starts and stops data recording. Options 228 displays a pressure
options dialog. Using the data cursor 230, the peak hyperemia is
shown by the system. In this example Run 216 is highlighted green,
indicating that the system recommends starting the chart
scrolling.
[0054] The exemplary Peak interface can display a number of
different variables. For example, IC/IV--hyperemic injection type,
peak time--time of day of last peak detected, Pd/Pa or
NPR--distal/aortic pressure ratio with or without venous pressure
normalization, Pa-Pd--gradient from aortic to distal pressure,
Pa--aortic pressure mean, Pd--distal pressure mean, Pv--venous
pressure mean (only if external or non-zero preset), HR--heart rate
(only if ECG displayed) can all be displayed as appropriate.
Additionally, when the system enters freeze 204 mode
iPa--instantaneous aortic pressure (under cursor) and
iPd--instantaneous distal pressure (under cursor) can be
displayed.
[0055] FIGS. 11 and 12 illustrate the Live 15 pressure display. The
live pressure graph can display various pressures including Distal
pressure, Aortic pressure, Distal pressure mean, Aortic pressure
mean, Venous pressure and ECG. The Live sub-tab 15 is configured
for Flow mode when only a Flow wire is connected to the system as
illustrated in FIG. 13. The screen displays data variables on the
left, graph and trend in the middle, and user buttons on the right.
The exemplary interface includes Freeze 232--stop the chart
scrolling, Zero 234--reset the aortic pressure input to 0 mmHg,
Base 236--capture a snapshot of the baseline condition, Peak
238--capture a snapshot of the peak response condition, Rec/Stop
240--start/stop recording, Options 242--start the flow options
dialog, Mode 244--switch between full screen, trend, and base and
peak snapshot display.
[0056] In the illustrated embodiment Zero 234 is illuminated in
green, indicating that the system recommends performing the zero
operations, which resets the aortic pressure. This state is not
shown in the figures. If the state were shown, while Zero 234 is
green, Base 236 and Peak 238 would be faded, indicating that the
user can not perform the base and peak operations until the zero
operation has been performed. After zeroing the system, Base 236
(FIG. 13) is illuminated in green, indicating that base mode should
be entered to capture a snapshot of the base condition. While Base
236 is green Peak 238 is faded, indicating that the peak operation
should not be performed until after the base operation is
completed. After the base 236 operation is performed, the Peak 238
option will be highlighted in green, indicating that the system
recommends calculating or searching for the peak response.
[0057] A large number of live flow variables can be displayed on
the Live pressure display for flow (FIG. 13). The interface can
display the following variables: CFR--coronary flow reserve;
IC/IV--hyperemic injection type; peak time--time of day of last
peak detected; HR--heart rate; Pa--aortic pressure; APV--average
peak velocity; APV-B--average peak velocity base; APV-P--APV last
peak value; DSVR--diastolic/systolic velocity ratio; DSVR-B--base
DSVR; DSVR-P--peak DSVR. In addition to displaying a large number
of variables, the system can display a number of waveforms in the
waveform portion 245 of the interface. Example waveforms include
ECG, Aortic pressure, velocity spectra, IPV and trend. Additional
variables and graphs are displayed in alternative embodiments.
[0058] FIG. 12 illustrates an exemplary live sub-tab in Combo mode.
The Live Tab is configured for Combo mode when a Flow wire and a
pressure wire are connected to the system. Also, the tab is
configured for Combo mode when a Combo wire is connected to the
system. The screen displays data variables on the left, graph and
trend in the middle, and user buttons on the right. The Combo
variables include: FFR--fractional flow reserve; CFR--coronary flow
reserve; HSR--hyperemic stenosis resistance; HMR--hyperemic
microvascular resistance; IC/IV--hyperemic injection type; peak
time--time of day of last peak detected; HR--heart rate;
Pa-Pd--gradient; Pd/Pa (NPR)--distal/aortic pressure ratio;
Pa--aortic pressure mean; Pd--distal pressure mean; Pv--venous
pressure mean; APV--average peak velocity; APV-b--average peak
velocity-base; APV-p--average peak velocity-peak. Additionally,
when the system is in Freeze 232 mode iPa, iPd and IPV can be
displayed. In combo mode the graph 246 can display various types of
data including IPV, Aortic pressure, Distal pressure, Mean aortic
pressure, Mean distal pressure, velocity spectra, and ECG
[0059] Entering the options 242 (FIG. 12) mode for the live
pressure display allows the user to control the following options:
Velocity Scale, Pressure Scale, Zero Offset, Scroll Speed, Search
Mode (IC or IV), IPV Threshold, and Clear Trend.
[0060] FIG. 14 illustrates an exemplary Playback 20 sub-tab while
frozen. The green Play 248 button indicates that the system
recommends running the chart. The Playback Tab is configured for
Pressure mode when playing back an archived file designated as a
pressure study, or when playing back recorded data from the current
study in which only a pressure wire is connected. The screen
displays data variables on the left, graph in the middle, and user
buttons on the right. The following options are available in
Playback 20: Play--start playing the recording (or Pause to stop
playing); Print--print a label or screen shot; Cursor <--move
the cursor left; Cursor >--move the cursor right; Options--start
Options Dialog;
[0061] While the Playback 20 sub-tab is displayed, a number of data
pressure variables can be displayed. Example data pressure
variables in Playback 20 mode include: FFR--fractional flow
reserve; IC/IV--hyperemic injection type; HR--heart rate (only
shown if ECG trace is selected); Pd/Pa--distal/aortic pressure
ratio; Pa--aortic pressure; Pd--distal pressure. The Playback 20
pressure graph (FIG. 14) can display various types of data. For
example Distal pressure, Aortic pressure, Distal pressure mean,
Aortic pressure mean and an Investigation cursor 262 can all be
displayed on the graph
[0062] The Playback sub-tab 20 can also be configured to display
flow data (FIG. 15). The Playback Tab is configured for Flow mode
when playing back an archived file designated as a flow study, or
when playing back recorded data from the current study in which
only a flow wire is connected. The screen displays data variables
on the left, graph and trend in the middle, and user buttons on the
right. In flow mode the following variables can be displayed:
HR--heart rate; CFR--coronary flow reserve/non-coronary flow
reserve; APV--average peak velocity; DSVR--diastolic/systolic
velocity ratio; Pa--aortic pressure. IPV, Aortic pressure, ECG, and
velocity spectra can all be displayed as graphs.
[0063] The Playback sub-tab can also be configured to display combo
data. The Playback Tab shall be configured for Combo mode when a
Flow wire and a Pressure wire are connected to the system in the
current study and playing back the current data, or when playing
back an archived file designated as a Combo study. The screen shall
display data variables on the left, graph and trend in the middle,
and user buttons on the right. In Combo mode, a number of variables
can be displayed, including FFR--fractional flow reserve;
CFR--coronary flow reserve; HSR--hyperemic stenosis resistance;
HMR--hyperemic microvascular resistance; IC/IV--hyperemic injection
type; peak time--time of day last peak detected; HR--heart rate;
Pd/Pa--distal/aortic pressure ratio; Pa--aortic pressure;
Pd--distal pressure; APV--average peak velocity; APV-B--average
peak velocity-base; APV-P--peak APV. The combo graph can display
various flow and pressure data including IPV; Aortic pressure;
Distal pressure; Mean aortic pressure; Mean distal pressure;
velocity spectra and; ECG.
[0064] The system guides the user through various tasks. For
example, referring to FIG. 12, a Zero 232 operation, Norm 235
operation, and Peak 238 operation can all be performed. When
performing a Zero 232 operation, the button is initially green.
After pressing the green Zero 232 button, the zeroing is
accomplished, the Zero 232 becomes blue and the Norm 235 button
turns green. When performing normalization, the Norm 235 button is
initially green. After pressing the green Norm 235 button,
normalization is accomplished, the button turns blue and the Peak
238 button turns green. To find the peak, the Peak 238 button is
pressed after Norm 235. FFR is performed and the button Peak 238
turns green again, allowing the user to find another peak. While
the Zero 232 button is green, the Norm 235 and Peak 238 buttons are
faded, indicating that it is not appropriate to perform the norm or
peak operations. Likewise, when the Norm 235 button is green, the
Peak 238 button is faded, indicating that it is not appropriate to
perform the peak operation. The faded system buttons prevent an
operator from performing steps in the wrong order.
[0065] FIG. 16 is a flowchart summarizing an exemplary set of steps
for displaying appropriate user interface screens based on the
cardiovascular sensor connected to the system. Initially, a sensor
connects to the system during step 272. Thereafter, during step
274, the system determines the type of sensor that was connected
during step 272. In one embodiment, the system determines the type
of sensor that was connected during step 272 by measuring a
resistance value. In this embodiment each type of sensor has a
unique resistance value and the system determines the type of
sensor by matching the measured resistance value to the known
resistance value of the sensor. In other embodiments, the system
may read a value representing the type of sensor from a memory in
the sensor. In still an alternative embodiment the sensor sends a
packet of information identifying the sensor type to the system. In
an exemplary embodiment the sensor is detected by measuring
resistance values. If the measured resistance is not in the
expected range then no sensor is connected to the system. In the
exemplary embodiment, the system also reads an EPROM contained
within the sensor that contains various calibration parameters.
After determining the type of sensor connected, during step 276 the
system displays appropriate user interface screens based on the
sensor connected during step 272. For example, as noted above, the
Live Tab 15 (FIG. 12) is configured for Combo mode when a Flow wire
and a pressure wire are connected to the system.
[0066] Illustrative embodiments of the present invention and
certain variations thereof have been provided in the Figures and
accompanying written description. Those skilled in the art will
readily appreciate from the above disclosure that many variations
to the disclosed embodiment are possible in alternative embodiments
of the invention. Such modifications include, by way of example,
modifications to the form and/or content of the disclosed functions
and functional blocks of the disclosed architecture, the
measurements processed by the host system, the calculations arising
from the measurements, the methods for setting modes and acquiring
the measurements. Additionally, imaging data, such as Intravascular
Ultrasound, Magnetic Resonance Imaging, Optical Coherence
Tomography, etc., may be obtained, analyzed, and/or displayed upon
the multipurpose application interface supported by the host system
described hereinabove. The present invention is not intended to be
limited to the disclosed embodiments. Rather the present invention
is intended to cover the disclosed embodiments as well as others
falling within the scope and spirit of the invention to the fullest
extent permitted in view of this disclosure and the inventions
defined by the claims appended herein below.
* * * * *