U.S. patent application number 11/549402 was filed with the patent office on 2007-10-04 for component-based catheter lab intravascular ultrasound system.
This patent application is currently assigned to Volcano Corporation. Invention is credited to Vincent Burgess, Henrick K. Gille, Edward A. Oliver, Nancy Perry Pool.
Application Number | 20070232933 11/549402 |
Document ID | / |
Family ID | 37963119 |
Filed Date | 2007-10-04 |
United States Patent
Application |
20070232933 |
Kind Code |
A1 |
Gille; Henrick K. ; et
al. |
October 4, 2007 |
Component-based catheter lab intravascular ultrasound system
Abstract
A componentized intravascular ultrasound system is disclosed
that flexibly integrates with a catheter lab infrastructure for
acquisition and display of intravascular information in a catheter
lab enviromnent. The system includes a patient interface module
(PIM) adapted to hold a catheter having an imaging probe located
near a distal end, a control panel, a monitor for displaying images
and patient data, and a processing unit. The processing unit is
communicatively coupled to the PIM, the control panel, and the
monitor. Furthermore the processing unit adapted to: coordinate
operation of the PIM, the control panel, and the monitor; and
generate images from image data provides by the PIM. The PIM,
control panel and monitor are independently positionable with
regard to one another.
Inventors: |
Gille; Henrick K.;
(Oceanside, CA) ; Burgess; Vincent; (San Diego,
CA) ; Pool; Nancy Perry; (El Dorado Hills, CA)
; Oliver; Edward A.; (Folsom, CA) |
Correspondence
Address: |
LEYDIG VOIT & MAYER, LTD
TWO PRUDENTIAL PLAZA, SUITE 4900
180 NORTH STETSON AVENUE
CHICAGO
IL
60601-6731
US
|
Assignee: |
Volcano Corporation
Rancho Cordova
CA
|
Family ID: |
37963119 |
Appl. No.: |
11/549402 |
Filed: |
October 13, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60727146 |
Oct 13, 2005 |
|
|
|
60825813 |
Sep 15, 2006 |
|
|
|
Current U.S.
Class: |
600/481 |
Current CPC
Class: |
A61B 8/4411 20130101;
A61B 8/467 20130101; A61B 5/055 20130101; G01S 15/899 20130101;
G01S 7/5208 20130101; A61B 6/4441 20130101; A61B 8/461 20130101;
A61B 8/468 20130101; A61B 8/464 20130101; A61B 8/565 20130101; G01S
7/52084 20130101; A61B 8/12 20130101; A61B 5/02007 20130101 |
Class at
Publication: |
600/481 |
International
Class: |
A61B 5/02 20060101
A61B005/02 |
Claims
1. A componentized system for acquisition and display of
intravascular information, comprising: a patient interface module
(PIM) adapted to hold an imaging flexible elongate member having an
imaging probe located near a distal end of the flexible elongate
member, and configured to obtain information for generating an
image of a vessel; a control panel; a monitor for displaying images
and other data for a patient; and a processing unit,
communicatively coupled to the PIM, the control panel, and the
monitor, the processing unit adapted to: coordinate operation of
the PIM, the control panel, and the monitor; and generate images
from image data provides by the PIM, wherein the PIM, control panel
and monitor are independently positionable with regard to one
another when used in a catheter-based imaging operation.
2. The componentized system of claim 1 wherein communications
interfaces and physical cabling support communications between the
PIM and the processing unit in instances where the processing unit
is located outside a region proximate a patient table.
3. The componentized system of claim 2 wherein a communications
link between the PIM and the processing unit includes a buffer
amplifier.
4. The componentized system of claim 1 wherein a communications
link between the processing unit and the monitor extends beyond a
region proximate a patient table.
5. The componentized system of claim 4 wherein the communications
link includes a buffer amplifier.
6. The componentized system of claim 1 wherein the processing unit
is further adapted to support archiving patient data including
images generated by the processing unit.
7. The componentized system of claim 1 further comprising a second
control panel, and wherein the processing unit supports and
processes input from simultaneously actively manipulated control
panels.
8. The componentized system of claim 7 wherein the second control
panel comprises a third party control panel provided by a catheter
lab control station distinct from the componentized system.
9. The componentized system of claim 1 wherein the components are
flexibly integrated with catheter lab infrastructure through a set
of connection brackets.
10. The componentized system of claim 9 further comprising a set of
integration configuration options characterizing a manner in which
components are integrated with catheter lab infrastructure.
11. The componentized system of claim 1 wherein the control panel
comprises a set of controls arranged into a set of regions based
upon their workflow roles.
12. The componentized system of claim 11 wherein the regions
comprise: a setup region including a set of buttons facilitating
setup of the system prior to acquiring patient images.
13. The componentized system of claim 12 wherein the first region
is positioned at a portion of the control panel distal to a user of
the control panel.
14. The componentized system of claim 11 wherein the regions
comprise: an action-oriented region including a set of buttons
accessed while acquiring images from a patient.
15. The componentized system of claim 14 wherein the
action-oriented region is positioned at a portion of the control
panel proximal to a user of the control panel.
16. A multi-region control panel, for an IVUS system, through which
a user controls acquisition and display of IVUS image information,
the control panel including a physical interface divided into
regions/sectors associated with particular workflow functionality,
the regions/sectors comprising: a first region including a set of
IVUS action controls for controlling patient image data
acquisition; a second region including pointer navigation controls;
and a third region including controls for setting up IVUS
operation.
17. The multi-region control panel of claim 16 wherein the third
region includes a sub-region including a set of controls for
selecting modes of IVUS operation.
18. The multi-region control panel of claim 16 wherein the pointer
navigation controls support multi-button mouse functionality.
19. The multi-region control panel of claim 16 wherein the third
region is positioned at a portion of the control panel distal to a
user of the control panel.
20. The multi-region control panel of claim 16 wherein the first
region is positioned at a portion of the control panel proximal to
a user of the control panel.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims priority of Gille et al. U.S.
provisional application Ser. No. 60/727,146 filed on Oct. 13, 2005,
entitled "Component-Based Catheter Lab Intravascular Ultrasound
System," and Pool et al. U.S. provisional application Ser. No.
60/825,813 filed on Sept. 15, 2006, entitled "Control Panel for a
Catheter Lab Intravascular Ultrasound System", the contents of both
of the above-identified provisional applications are expressly
incorporated herein by reference in their entirety including the
contents and teachings of any references contained therein.
FIELD OF THE INVENTION
[0002] The present invention generally relates to the field of
ultrasound imaging systems, and more particularly to systems used
to diagnose and treat vascular disease.
BACKGROUND OF THE INVENTION
[0003] The development of new medical technologies has provided an
increasing number of options available to doctors for the diagnosis
and treatment of cardiovascular diseases. The availability of such
equipment has improved the ability of doctors and surgeons to
detect and treat cardiovascular disease. Intravascular imaging
technologies have enabled doctors to create and view a variety of
images generated by a sensor inserter within a vasculature. Such
images compliment traditional radiological imaging techniques such
as angiography by providing images of the tissue within vessel
walls rather than showing a two dimensional lumen image.
[0004] In the area of cardiovascular imaging, doctors now routinely
rely upon a variety of products and technologies including
intravascular ultrasound (IVUS), angiogram, and MRI imaging
devices. In fact, a recent trend is to combine external and
invasive (IVUS) imaging methods within a single session with a
patient. In fact such diverse technologies are now used even
simultaneously to improve tracking the progress of a diagnostic
and/or treatment device mounted upon a catheter during treatment of
a patient.
[0005] Known IVUS systems such as the InVision system from Volcano
Corporation are relatively large multi-component systems that are
mounted upon a trolley that takes up a space about the size of a
small refrigerator. These systems contain the displays, control
panels, power supplies and computers in a single large chassis that
is mounted upon a set of wheels to facilitate easy movement to any
operating room/imaging lab where it is needed.
[0006] The benefits of IVUS systems are well documented. However,
in a relatively crowded operating room environment, the mechanical
configuration of known trolley-based IVUS systems can pose problems
with regard to having clear, unobstructed access to a patient.
Therefore, recent versions of IVUS systems have expanded the form
factor options from the trolley to ones that adopt a "distributed
integration" approach wherein the components are separated (i.e.,
they no longer reside within a single chassis) and integrated with
existing support structures within an operating room/catheter lab.
In a known system, a monitor is mounted permanently on a boom above
a patient table, a controller is mounted upon a rail on the patient
table, a CPU is placed proximate the patient table, and a patient
interface module is connected to the CPU via a short cable. In the
known system, the short power/communications cable connecting the
patient interface module to the patient interface module is limited
in length and restricts placement of the CPU.
[0007] Another potential barrier to adoption of invasive imaging
techniques is the ease of use of such systems. Known systems tend
to include generalized interfaces that are not particularly
suited/adapted for use in a catheter lab where space is limited and
ease of use is desired when a procedure must be completed
potentially very quickly and without error. Training is a problem
due to staff turn over, so a system that is easy to learn how to
use and retain the information is very important.
SUMMARY OF THE INVENTION
[0008] In accordance with the present invention an intravascular
ultrasound (IVUS) system is integrated into a catheter
lab/operating room as a set of modular IVUS system components.
Display, processing unit and control panel components can be placed
in their most desired locations (even in another room) without
restrictions arising from cable length limitations.
[0009] In particular embodiments, low power processors like the new
Intel Pentium Sossaman processor reduce the cooling requirements
thereby potentially reducing the size of blower fans and the
processing unit chassis. A reduced chassis size expands the
potential locations for the processing unit (e.g., under a patient
table). The display can be mounted in several locations in the
catheter lab or control room. The control panel can be mounted
remotely and outside a sterile field.
[0010] The system includes a control panel through which a user
controls the acquisition and display of IVUS image information. In
illustrative embodiments the physical interface of the control
panel is divided into regions associated with particular workflow
functionality. The combination of functional regions and functions
performed by controls (e.g., buttons, mouse/trackball, etc.) within
particular regions facilitates a superior user experience including
an enhanced learning curve as well as an ability to make selections
by feel (as opposed to sight). In the disclosed embodiment a first
region includes a set of IVUS action keys, a second region includes
pointer navigation controls (e.g., trackball) with multi-button
mouse functionality, and a third region includes controls for
selecting modes of IVUS operation.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] While the 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
drawing of which:
[0012] FIG. 1 is a schematic drawing depicting the components and
communicative connections of an exemplary IVUS system suitable for
integration with catheter lab/operating room infrastructure;
[0013] FIG. 2 depicts an exemplary control panel including a
keyboard in its slideout position;
[0014] FIG. 3 depicts an exemplary portable configuration of the
system including components and their associated carrying case
configuration;
[0015] FIG. 4 depicts an exemplary integrated system including an
integrated third party controller;
[0016] FIG. 5 illustratively depicts an exemplary control panel
configuration; and
[0017] FIG. 6 comprises a chart outlining a variety of
configuration options supported by an exemplary componentized
system.
DETAILED DESCRIPTION OF THE DRAWINGS
[0018] The IVUS (intravascular ultrasound) system embodying the
present invention is based on the functionality derived from
existing IVUS systems, including ChromaFlo and other features
present in the existing system. An exemplary system uses legacy
internal circuit board architectures incorporated into previously
provided systems, including, for example, analog and digital
boards. The components of an exemplary system and their general
descriptions are provided herein below with reference to FIG. 1.
The components are physically divided, appropriately sized, and
connected in a manner that improves their ability to seamlessly
integrate with existing catheter lab/operating room infrastructure
and thereby maximize accessibility to a patient and other medical
equipment in the room.
[0019] Turning to FIG. 1, a photographic image depicts a set of the
primary components of an IVUS system suitable for integration in a
catheter lab/operating room environment. It is noted that the
exemplary installation depicted in FIG. 1 depicts
mounting/placement of the various components on a "shortened"
patient table 102 (used for demonstration purposes). In an actual
operating room environment the table is significantly longer and
more sturdy in construction to support a patient during a
catheterization procedure.
[0020] A processing unit 100, incorporating many of the
capabilities and functionality of known personal computers,
coordinates operation of the peripheral components of the exemplary
IVUS system, processes commands from attached controllers, issues
control commands to an IVUS device (via a PIM) and processes IVUS
data received from the IVUS device to render corresponding
graphical IVUS image data. The resulting IVUS image data drives
communicatively coupled graphical displays. The image data is also
stored on both local and networked data storage devices.
[0021] In an exemplary embodiment, a housing for the processing
unit 100 has suitable dimensions to facilitate placement of the
processing unit 100 in a variety of desirable locations, both
proximate (e.g., on a shelf 104) and remote from the patient table.
In the illustrative example the housing of the processing unit 100
occupies a space of about 16 inches square and about 6 inches deep.
The dimensions of the processing unit 100 (housing) vary in
accordance with various embodiments of the invention and should not
be taken as limiting the scope of the invention. Furthermore, the
location of the processing unit 100 is very flexible in view of its
size and the signal transmission capabilities of physical
communications links between the processing unit 100 and
peripherally connected components including: a control panel 110, a
monitor 112, and a patient interface module (PIM) 114. The
interconnect cabling and the peripheral components are described
further herein below.
[0022] The processing unit 100 includes a commercially available
mother board with, for example, an INTEL PENTIUM Sossaman
(dual-core, low-power consumption) microprocessor, 2 GB of system
RAM, one 3.5'' hard drive, a medical grade power supply, an
ultrasound signal processing card, and a remote control interface
card. In an exemplary embodiment the external interface of the
processing unit 100 and embedded control logic support multiple,
simultaneously active (i.e., sending asynchronously processed
control instructions to the processing unit 100) control panels
(e.g., control panel 110) and multiple remote monitors (e.g.,
monitor 112). The multiple control panels and remote monitors are
not limited to two, and can indeed exceed two. Support of multiple
active controllers (e.g., control panel 110) allows two or more
users to send control signals governing the operation of the system
to the processing unit 100 without locking out any of the
simultaneous users. Such operating mode supports remote assistance
for a user operating the local control panel 110.
[0023] The control panel 110 and the monitor 112 are connected via
communications cabling supporting remote positioning/operation of
the peripheral components from the processing unit 110 during a
catheterization procedure. By design, the processing unit 100 is
compact, relatively light weight, very quiet and operates without
direct user contact once powered up. The processing unit 100's
housing, by way of example, incorporates mechanical mounting
features (e.g., hooks, clamps, etc.) allowing the processing unit
100 to be secured to mounting rails on the patient table 102.
Alternatively, the processing unit 100 is mountable on wall
attached rails. In various embodiments, the processing unit 100
includes a variety of storage devices including, for example: a
hard drive, DVD/CD burner/player, VCR recorder/player, etc.). The
secondary storage device can also be a peripheral device attached
via, for example, a USB cable to the processing unit 100.
[0024] Turning to the control panel 110 component of the system, in
the exemplary embodiment, the control panel 110 includes a plastic
housing that holds various user input interfaces. Approximate
dimensions of the control panel are: 10''.times.16''.times.4''
(H.times.W.times.D). By way of example, the exemplary control panel
110 includes a slide out keyboard 111 (see, FIG. 2) and a touch
interface (described further herein below with reference to FIG.
5). The enclosure is mountable on a variety of structures
including, for example, a support arm attached to a rail of the
patient table 102 or an articulated wall mount. The control panel
110 can be placed away from the immediate vicinity of the patient
table 102 such as on a table in a remote control room or mounted to
a roll around (e.g., IV pole) cart. The control panel 110 is
communicatively coupled to the processing unit 100 via a cable of
potentially significant length. In yet other embodiments, the
control panel is located on a table near a secondary local medical
grade display (not shown) which receives a copy/clone of the
primary image displayed on the monitor 112. The second display
(e.g., a 15 inch LCD monitor) requires an additional cable from the
processing unit 100. The control panel 110 includes, by way of
example, an additional USB port so that it can also be connected to
a printer or other suitable USB-enabled peripheral device.
[0025] Referring now to the monitor 112, in an exemplary embodiment
the monitor 112 is a 19 inch LCD monitor (e.g., an InVision
monitor) for providing an image, based upon image data rendered by
the processing unit 100, to viewers in the vicinity of the patient
table 100. In an exemplary embodiment the monitor 112 is mounted to
an articulated arm attached near the "foot" end of the patient
table 102. The mounting arm incorporates many degrees of motion
freedom thereby enabling rotating and positioning the monitor 112
so that it is entirely under the patient table and out of the way
if desired. When needed for IVUS, the monitor 112 is repositioned
so that it is easily viewed by a catheter lab technician standing
near the patient table 102.
[0026] The remote control/display system supported by the
processing unit 100 is used to allow remote control of the
processing unit 110 by multiple remote control devices (e.g., the
control panel 110). The system similarly supports remote display of
video images from the processing unit 100 on multiple displays.
[0027] Primary system components on the processing unit 100
supporting communications between the processing unit 100 and a
peripheral control/display device are a CPU integrated signal
sender and a remote signal receiver. The interconnection is by
means of a single CAT6 double shielded cable from the CPU to each
of the 2 remote control panels and each of the 2 remote displays.
Power is provided over the CAT6 cable so no remote power supply is
required.
[0028] The exemplary system also includes a known PIM 114 to which
appropriate IVUS catheters are communicatively coupled for an
imaging session. The PIM 114 can be any of a wide variety of
interface modules that interface imaging catheters to a processing
unit such as processing unit 100.
[0029] Another notable feature of the illustrative embodiment is
the ability of the components to be separated by potentially large
distances. Through the use of high quality cabling (both USB and
VGA) and sufficiently powered transmission interfaces (e.g.,
in-line buffer amplifiers), components of the system (including
remote instances of peripheral control panels and monitors) are
positioned outside the immediate vicinity of the patient table 100,
such as across the room or even in a separate room up to 150 feet
from the patient table, without significant signal loss. In an
exemplary embodiment, the cable connecting the PIM 114 and the
processing unit 100 is up to approximately 100 feet. In such
circumstances the extended length is accommodated by a greater
gauge wire in the connector cable as well as through adjustments
for signal transmission delays.
[0030] In an exemplary embodiment wherein the processing unit 100
is mounted on a lower shelf of the patient table 102, the wiring to
and from the processing unit 100 is routed to remotely located
independently/flexibly located (remotely located) peripheral
components, including possibly remotely located versions of the
control panel 110 and the monitor 112, by cabling strung across the
floor under suitable cable covers. Cabling for other peripheral
components positioned in the proximity of the patient table 102,
such as the catheter lab control panel 110 and the patient
interface module (PIM) 114, are routed directly from the processing
unit 100 to these components. In the illustrative example in FIG.
1, the monitor 112 is mounted to the patient table 102, in close
proximity to the processing unit 100, and a direct VGA cable
connection is provided. The remaining cable is CPU AC power which
should be available from an AC outlet on or near the patient table
mounting pedestal. There is no AC power required for the control
panels attached to the CPU.
[0031] The cabling between the various components supports
communications using a variety of protocols. By way of example, the
control devices operate via USB and TCP/IP protocols. The
video/analog cables utilize a VGA or analog Ethernet scheme.
However, in alternative embodiments digital video signaling schemes
are used. Finally, while cables are described for communicatively
coupling the components, in alternative embodiments wireless
technology links one or more of the inter-communicating components
of the system.
[0032] The exemplary component-based system also includes an
archive station 116. In the illustrative embodiment depicted in
FIG. 1, data is moved from the processing unit 100 to a shared
image data server running on the archive station 116. By way of
example, the data is transmitted via Ethernet protocol to a DICOM
workstation (the archive station 116) for storage within an
appropriate directory or database, or alternatively burning the
image data to DVD or other removable computer readable memory
media. Data can also be moved from the processing unit 100 by means
of a removable flash drive of, for example, 4 GB capacity. The
flash drive is thereafter installed on another computer including a
DVD burner for review or burning to a DVD. However, in yet another
alternative arrangement, archival capabilities are provided in the
form of a desk top/tower PC workstation including a commercial
monitor (e.g., a 15 inch LCD) and a DVD writer. The workstation
connects to the processing unit 100, for example, by means of an
Ethernet. The files stored on the hard drive of the processing unit
100 are moved to the workstation for review and archiving to a DVD
without impacting the operation of the processing unit 100. In
still another alternative embodiment the functionality and hardware
(e.g., hard drive and CD/DVD burner) of an archive station is
incorporated into the processing unit 100. A printer, such as a
color dye sublimation printer, is optionally attached to the
workstation to permit image printing.
[0033] The componentized arrangement of the disclosed system
facilitates providing a portable system. A portable version of the
system (see, FIG. 3) depicted in FIG. 1 uses the same processing
unit 100 depicted in FIG. 1. However, the processing unit 100 is
mounted in a carrier to allow it to be easily transported. The
control panel 110 and archive station 116 are transported by
carriers. The monitor 112 is potentially any one of a variety of
commercially available medium scale (e.g. 15 inch) LCD monitors. If
desired, an optional collapsible cart, chosen from one of many
commercially available models is used to transport the separately
bagged/encased components.
[0034] Standard-dimensioned mounting rails are generally available
in catheter labs. The installation kit for the system, by way of
example, includes a set of rail mounting hardware to allow
customization of the mechanical installation to meet the unique
positioning requirements of each catheter lab.
[0035] Another aspect of the disclosed system is interoperability
support. In the exemplary embodiment, the processing unit 100
includes an Ethernet connection that allows connection of the
processing unit 100 to a hospital LAN, DICOM workstation, archive
workstation, or remote control consoles such as ones provided from
GE (see, e.g., controller 410 in FIG. 4), Siemens or other
manufacturers. In support of this functionality, one or more
additional software modules are provided to interpret commands
issued by these remote control devices and provide the proper
response (including image data translators to match the supported
protocols of the attached devices and their associated image
display systems).
[0036] The following summarizes a set of functional/operational
features of an exemplary componentized system described herein
above. First, the system unobtrusively integrates with existing
equipment in a catheter lab. As such the system can always be in
position, always powered and ready to perform an IVUS imaging
session. Second, the system occupies no floor space. Third, the
system does not noticeably alter the lab's working environment
since it generates very little noise (the low power processors
generate less heat and therefore smaller fans can be used). Fourth,
the system accepts, and processes control commands issued from
multiple, simultaneously active distinct controllers. Multiple
users can simultaneously submit control commands that are processed
as they are received by the processing unit 100. Similarly, the
system supports multiple, potentially remotely located, monitors
for displaying IVUS images rendered by the processing unit 100.
Sixth, the system can be dismantled and packaged in hand-held
portable carriers in a portable embodiment. The above functionality
is provided by a system that incorporates all the functional
capabilities of full-size currently available IVUS systems.
[0037] While various examples are provided herein, it is noted that
other embodiments include any of a variety of alterations. For
example, the processing unit 100 can occupy any of a variety of
form factors such as a cube. The motherboard of the processing unit
100 is, by way of example, any microATX or ATX sized board,
allowing any of the commercially available PENTIUM processors to be
used. The control panel 110 can be connected by means of a WiFi
connection using suitable adapters. The video image from the IVUS
system can be broadcast to remote locations using wireless
technology. Any number of monitors, keyboards, trackballs or mice
can be attached to the processing unit 100 and used simultaneously
(no controller lock out) with their asynchronous requests being
handled as they are received by the processing unit 100. By adding
suitable interface software, the processing unit 100 can be
controlled from the control panels of patient tables or X-Ray
consoles made by GE, Philips, Siemens, etc.
[0038] The following summarizes features and performance
characteristics of the componentized system depicted in FIG. 1,
some of which have been discussed previously herein above.
Generated/Displayed Images
[0039] The system supports a combination of tomographic and
sagittal views including: tomographic IVUS images, sagittal views
either vertically or horizontally simultaneous with tomographic
display. All measurements are displayed on imaging views. Data
capture and display is carried out in the form of recorded video
loops and still images. The system supports replaying and reviewing
captured images, data capture and display in all modes including:
virtual histology, flow. A variety of imaging technologies include
Intracardiac Echocardiography (ICE), flow, pressure, etc.
[0040] With regard to the display screen, text is displayed by
default in English. Additional supported languages include: French,
Italian, German, and Spanish. Other displayed information includes:
patient demographic information; current date, time, software
version; patient co-morbidity data (in the patient screen);
measurements, including distances, areas, longitudinal distances,
and borders.
Catheter Support:
[0041] The processing unit 100 supports a variety of cardiovascular
and peripheral IVUS catheters (both array and rotating crystal) and
flexibly supports later developed catheter designs including
Intracardiac Echocardiography (ICE) and capacitive Microfabricated
Ultrasonic Transducer (cMUT) catheters.
Instrument Set Up/Functions:
[0042] Standard local video output is provided as well as multiple
remote video outputs. Communications set up include network (DICOM)
and Ethernet RJ-45. A connector on the processing unit 100 chassis
supports remote USB control panel, trackball or keyboard input. The
system supports communication with a remote archiving station for
color image printing and DVD recording of patient data. The system
supports interfacing with controls of others including GE, Siemens,
Philips, etc.
Mechanical Design:
[0043] The system components all have computer components and
printed circuit boards integrated into a small, reduced weight,
housing, suitable for mounting on, or near the patient table in a
catheter lab or alternatively a remote location within 30-50 meters
of the patient (depending on the component) in a remote control or
equipment room. The control panel 110 is mounted from the DIN rails
on the patient table 102 in the catheter lab and/or a remote
control room. The control panel 110 connects to the processing unit
100 by a single cable. The control panel 110 also includes mounting
hardware for mounting from a roll around equipment cart or from a
wall. The Control Panel enclosure is also attachable to a
boom/arm/mount that can be mounted on or to the control area of the
patient table. It should also be capable of being mounted to a roll
around IV pole cart. It should also be possible to place it on a
flat table for desktop use.
Display:
[0044] The monitor 112 is any of a variety of available monitors
including 15/17/19 inch (diagonal) flat panel LCD monitors. The
monitor is of suitable quality such that the monitor screen is
visible in a reduced light catheter lab environment with minimal
distortion when viewed from side or off angle (up to 40-45 degrees
off angle). The display is mountable in a variety of ways including
on an articulated arm that allows the display position to be
changed from stowed under the patient table, to easily visible at
the patient table. The display is also mountable via a bracket
attached to the patient table 102.
Control Panel:
[0045] The control panel connects to the processing unit 100 via a
USB cable and permits operation of the GUI and patient data entry
using the pull out keyboard. The control panel is mountable on or
near the patient table 102, on a freestanding mobile IV pole
carrier, or from an articulated wall mounted arm, depending on user
preferences. The control panel communicates with the processing
unit from a remote control room
User Interface:
[0046] The user interface embodied in the monitor 112 displays and
the control panel 110 (described herein below) provide an
intuitive, easy to use interface that follows a typical IVUS case
workflow. The user can use the mechanical keys on the control panel
or, after powering on, navigate via soft keys on the user
interface. The primary operator control is provided through
on-screen curser and screen controls on the monitor 112 display.
When operating in a virtual histology mode, the system supports
plaque/tissue characterization and volume determinations, including
user driven border editing on the tomographic and in-line digital
views, and reanalysis of statistics. A remote archiving station
consolidates the tasks of saving data, printing data and/or
networking data.
Data Storage:
[0047] A variety of data storage is supported by the exemplary
system including the following:
[0048] Primary Storage Medium: Internal CPU hard drive(s).
[0049] Secondary Storage: Media will be DVD-R disks for archival
purposes.
[0050] Tertiary Storage: Hospital DICOM server via the PACS
network.
[0051] Quaternary Storage: Removable USB flash drive for transfer
to a workstation.
[0052] Ability to review data on systems from both primary and
secondary sources.
[0053] Ability to view Volcano images on a computer, such as in
their office or home
[0054] Minimum three, 90 second video loops stored @ 30 fps
LCD/CPU Specification
[0055] In an alternative embodiment the monitor 112 and the
processing unit 100 are contained within a single housing and used
in hospital catheter laboratories. It is designed to mount from the
patient table mounting rails using mounting hardware. The following
specifications describe the design details for this variation of
the above-described componentized system.
[0056] The case has overall dimensions of 15'' H.times.17''
W.times.5'' D and a weight of approximately 25 pounds (about 10
Kg). Cooling is provided via a 1.times.80-120 ccm cooling fan,
blowing air into case, exiting from bottom or sides. The processor
is a low power, dual-core PENTIUM Sossaman processor.
[0057] The motherboard includes at least two PCI slots for
connecting hosted digital and analog boards of the processing unit
100.
[0058] Turning to FIG. 5, an exemplary control panel
button/trackball interface is depicted. In general, a user
interacts with the system through the control panel 110 via a set
of buttons configured, by way of example in a manner set forth in
FIG. 5. The elements of the control panel include: a Power on/off
500; a trackball 502 (used to position the cursor on the screen of
the monitor 112); screen selection keys including Settings 504,
Record 506, Home 508, Save Frame 510, measure 512, play 514, and
stop 516; Select (+) 518 and Menu (-) 520 keys; a Bookmark 522 key;
a standard alphanumeric keyboard (retracted below control panel); a
ChromaFlo.RTM. 524 key; a VH 526 key; a ringdown key 528; a display
key 530; a print key 532; and a Keyboard indicator 534. The
functionality of each of these elements is discussed herein
below.
[0059] In an exemplary embodiment the various action/control
buttons are grouped to facilitate user workflow and include color
coding coordinating with the software keys and icons to promote
ease of use. A power button 500 turns the system on or off and
illuminates when the system is plugged in. In addition to the power
button 500, a set of buttons along a top row (e.g., settings 504,
display 530, and print 532) facilitate set-up and mode selection.
These top-row buttons/actions are generally not part of the routine
work flow. The two groups include:
Set-up & Display
[0060] Settings 504: Changes system settings like date and time;
also permits setting and editing default configurations.
[0061] Display 530: Displays a large IVUS image with measurements
and demographics to facilitate large viewing.
[0062] Print 532: Prints a 6.times.4 inch photo of the current
image on the screen
Modes
[0063] Ringdown 528: Turn Ring Down on or off
[0064] VH Mode 526: Turns virtual histology display on or off
[0065] ChromaFlo (flow image) 524: Turns ChromaFlo on or off
[0066] Two groups of buttons/controls lie below the top row. The
two groups are action-oriented and designed with the user in mind
to facilitate ease of use and retention of training. These buttons
are typically used during a routine patient case:
Workflow Buttons that Facilitate Ease of Use of System
[0067] Record 506: Records a video loop
[0068] Stop 516: Stops the recording of a video loop. Press to
Freeze a live image
[0069] Home 508: Press to view the live image
[0070] Play 514: Play a recorded video loop
[0071] Save Frame 510: Press during Live mode to save one frame
[0072] Measure 512: Provides access to measurement options such as
diameter, length and borders
Buttons Grouped Around the Trackball to Facilitate Navigation
During the Patient Case
[0073] Select (+) 518: Press to select tabs, areas, or points. It
is similar to left-clicking with a mouse.
[0074] Menu (-) 520: Press to end your selection points. It is
similar to right-cliclcing with a mouse.
[0075] Bookmark 522: Press while recording a loop to select
specific areas of interest
Trackball 502
[0076] The trackball 502 moves the cursor on the monitor 112 to
allow function selection. The trackball 502 is also useful for
selecting annotation locations and making measurements.
[0077] Keyboard 534: Points to the retractable keyboard beneath the
control panel
Alphanumeric Keyboard
[0078] A standard alphanumeric keyboard is contained in a
retracting tray under the control panel button/user interface and
is used for data entry and image annotation. To use the keyboard,
pull the latch underneath the keyboard tray and pull the keyboard
tray out.
[0079] Turning briefly to FIG. 6, a two dimensional array presents
a set of options associated with each of a set of components that
make up the system. The extent of the choices for each component
demonstrates the high degree of configurability and adaptability of
the system to various users' needs. The following options are
available for the processing unit 100 (that includes a DVD
burner/player for archiving and retrieval), location: [0080] 1-CPU
on patient table, spanning rails [0081] 2-CPU on patient table LHS,
rail mounted [0082] 3-CPU on patient table RHS, rail mounted [0083]
4-CPU in Equipment Room, wall mounted [0084] 5-CPU in Equipment
Room, table mounted [0085] 6-CPU in Control Room, floor standing
[0086] 7-CPU in Control Room, wall mounted The following options
are available for Primary Monitor location: [0087] 1-Volcano LCD
Monitor, Pt table "foot end" mounted, arm attached to rail [0088]
2-Use existing monitor in display cluster (Determine if XGA
compatible and where aux video input is located) [0089] 3-Remote
display, on table in Control Room (Determine cable length from CPU,
if>15 ft, use Ethernet link and I/O box) The following options
are available for Secondary Monitor location: [0090] 0-None
required [0091] 1-Remote Volcano display, located on table top in
Control Room [0092] 2-Wall mounted Volcano display located in Cath
Lab [0093] 3-Volcano display added to display cluster [0094]
4-Existing display, mounted in display cluster (Determine if XGA
compatible and if switched video input is available) The following
options are available for Main Control Panel location: [0095]
1-Attached to pt table rail, LHS, or RHS [0096] 2-Attached to wall
mount in Cath Lab [0097] 3-Attached to IV portable cart in Cath Lab
[0098] 4-In Control Room, table mounted [0099] 5-In Control Room,
wall mounted [0100] H-For 3,4,5 above, attach color printer The
following options are available for Remote Control Panel location:
[0101] 0-None required [0102] 1-Attached to wall mount in Cath Lab
[0103] 2-Attached to IV portable cart in Cath Lab [0104] 3-In
Control Room, table mounted [0105] 4-In Control Room, wall mounted
[0106] H-For 3,4 above, attach color printer The following options
are available for Archiving Station: [0107] 0-None required [0108]
1-Use DICOM workstation for archive [0109] 2-Volcano Archive
station in Control Room [0110] 3-Volcano Archive station in Second
Control Room [0111] H-For 2, 3 above, attach color printer
[0112] The above described component option sets are exemplary and
are by no means limiting in nature as the disclosed system is
designed with the intention of supporting a highly configurable
system.
[0113] Systems and their associated components have been described
herein above with reference to exemplary embodiments of the
invention including their structures and techniques. In view of the
many possible embodiments to which the principles of this invention
may be applied, it should be recognized that the embodiments
described herein with respect to the drawing figures are meant to
be illustrative only and should not be taken as limiting the scope
of invention. Therefore, the invention as described herein
contemplates all such embodiments as may come within the scope of
the following claims and equivalents thereof.
* * * * *