U.S. patent application number 13/679795 was filed with the patent office on 2013-05-16 for medical workflow system and method.
This patent application is currently assigned to Volcano Corporation. The applicant listed for this patent is Volcano Corporation. Invention is credited to Aaron Cheline, Asher Cohen, Duane De Jong, Gerald Lea Litzza, Fergus Merritt.
Application Number | 20130123616 13/679795 |
Document ID | / |
Family ID | 48280119 |
Filed Date | 2013-05-16 |
United States Patent
Application |
20130123616 |
Kind Code |
A1 |
Merritt; Fergus ; et
al. |
May 16, 2013 |
Medical Workflow System and Method
Abstract
A method of conducting a medical workflow with a touch-sensitive
bedside controller is disclosed. The method includes initiating a
medical workflow using a graphical user interface on the bedside
controller, positioning an imaging tool within a patient's body
based on images captured by the imaging tools and displayed on the
bedside controller, controlling the commencement and termination of
a recordation of images captured by the imaging tool using the
graphical user interface on the bedside controller, navigating
through the recorded images to identify an image of interest using
the graphical user interface on the bedside controller, and
performing measurements on the image of interest using the
graphical user interface on the bedside controller.
Inventors: |
Merritt; Fergus; (El Dorado
Hills, CA) ; Cohen; Asher; (Sacramento, CA) ;
De Jong; Duane; (Elk Grove, CA) ; Litzza; Gerald
Lea; (Sacramento, CA) ; Cheline; Aaron;
(Sacramento, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Volcano Corporation; |
San Diego |
CA |
US |
|
|
Assignee: |
Volcano Corporation
San Diego
CA
|
Family ID: |
48280119 |
Appl. No.: |
13/679795 |
Filed: |
November 16, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61560677 |
Nov 16, 2011 |
|
|
|
Current U.S.
Class: |
600/427 ;
600/407; 600/425; 600/431; 600/463 |
Current CPC
Class: |
A61B 5/7445 20130101;
G16H 40/63 20180101; A61B 6/504 20130101; A61B 8/12 20130101; A61B
8/56 20130101; G06F 3/04883 20130101; A61B 5/0013 20130101; A61B
5/0095 20130101; A61B 8/4416 20130101; A61M 5/007 20130101; A61B
5/1076 20130101; A61B 5/0084 20130101; A61B 5/7435 20130101; G06F
3/01 20130101; A61B 5/0059 20130101; A61B 8/467 20130101; G06F
3/041 20130101; A61B 6/56 20130101; A61B 5/0066 20130101; A61B
5/0077 20130101; A61B 8/565 20130101; A61B 2560/0437 20130101; A61B
2560/0487 20130101 |
Class at
Publication: |
600/427 ;
600/407; 600/463; 600/425; 600/431 |
International
Class: |
A61B 5/00 20060101
A61B005/00; A61M 5/00 20060101 A61M005/00; A61B 8/12 20060101
A61B008/12 |
Claims
1. A method of conducting a medical workflow with a touch-sensitive
bedside controller, the method comprising: initiating a medical
workflow using a graphical user interface on the bedside
controller; positioning an imaging tool within a patient's body
based on images captured by the imaging tools and displayed on the
bedside controller; controlling the initiation and termination of a
recordation of images by the imaging tool using the graphical user
interface on the bedside controller; navigating through the
recorded images to identify an image of interest using the
graphical user interface on the bedside controller; and performing
measurements on the image of interest using the graphical user
interface on the bedside controller.
2. The method of claim 1, wherein the initiating includes selecting
the medical workflow out of a plurality of medical workflows
presented as selectable options within the graphical user
interface.
3. The method of claim 2, wherein the plurality of medical
workflows includes two or more of an intravascular ultrasound
(IVUS) imaging workflow, an intravascular photoacoustic (IVPA)
imaging workflow, an optical coherence tomography (OCT) workflow, a
forward looking IVUS (FL-IVUS) workflow, a fractional flow reserve
(FFR) workflow, a coronary flow reserve (CFR) workflow, and an
angiography workflow.
4. The method of claim 1, wherein the performing measurements
includes touching and releasing portions of the image of interest
as it is displayed on the bedside controller to make one of an area
measurement and a diameter measurement.
5. The method of claim 4, wherein the touching and releasing
includes making one of the area measurement and the diameter
measurement without first selecting a measurement mode
corresponding one of the area measurement and the diameter
measurement.
6. The method of claim 1, wherein the initiating, positioning,
controlling, navigating, and performing are performed on the
bedside controller in a sterile field.
7. The method of claim 1, wherein navigating through the recorded
images includes navigating through a condensed view of all of the
recorded images.
8. The method of claim 1, wherein navigating through the recorded
images includes performing navigation-type gestures on the
touch-sensitive display.
9. The method of claim 1, wherein performing measurements includes
annotating the image of interest with the measurements.
10. The method of claim 9, further including saving to a processing
system the image of interest with the measurement annotations
thereon.
11. The method of claim 1, wherein the imaging tool is a sensor
disposed on a catheter within a vessel of the patient.
12. The method of claim 11, wherein the controlling includes
coordinating the recordation with a pullback of the catheter.
13. The method of claim 1, wherein controlling the initiation and
termination includes selecting a record option in the graphical
user interface to initiate the recordation.
14. The method of claim 1, further including receiving haptic
feedback in response to performing measurements on the image of
interest using the graphical user interface.
15. The method of claim 1, wherein the images captured by the
imaging tool are associated with one of intravascular ultrasound
(IVUS), intravascular photoacoustic (IVPA), optical coherence
tomography (OCT), forward looking IVUS (FL-IVUS), fractional flow
reserve (FFR), coronary flow reserve (CFR), and angiography.
16. A bedside controller, comprising: a housing; a touch-sensitive
display disposed within a surface of the housing and configured to
display images and receive user input on the surface; a processor
disposed within the housing; a communication module disposed within
the housing, communicatively coupled to the processor, and
configured to transmit and receive medical data; and a
non-transitory computer readable storage module disposed within the
housing, communicatively coupled to the processor, and including a
plurality of instructions stored therein and executable by the
processor, the plurality of instructions including: instructions
for rendering a graphical user interface (GUI) on the
touch-sensitive display; instructions for displaying images of a
patient as they are being captured by an imaging tool disposed
within the patient's body; instructions for initiating and
terminating a recordation of the images based on user input to the
GUI; instructions for displaying the recorded images within the GUI
so that a user may identify an image of interest; and instructions
for making a measurement on the image of interest based on a user
measurement input to the GUI.
17. The bedside controller of claim 16, wherein the images of the
patient are associated with one of intravascular ultrasound (IVUS),
intravascular photoacoustic (IVPA), optical coherence tomography
(OCT), forward looking IVUS (FL-IVUS), fractional flow reserve
(FFR), coronary flow reserve (CFR), and angiography.
18. The bedside controller of claim 16, wherein the plurality of
instructions includes instructions for presenting a plurality of
workflow modes selectable by a user through the GUI.
19. The bedside controller of claim 18, wherein the plurality of
instructions includes instructions for receiving a user selection
of a workflow mode out of the plurality of workflow modes through
the GUI.
20. The bedside controller of claim 18, wherein the plurality of
workflow modes includes two or more of an intravascular ultrasound
(IVUS) imaging mode, an intravascular photoacoustic (IVPA) imaging
mode, an optical coherence tomography (OCT) mode, a forward looking
IVUS (FL-IVUS) mode, a fractional flow reserve (FFR) mode, a
coronary flow reserve (CFR) mode, and an angiography mode.
21. The bedside controller of claim 16, wherein the instructions
for displaying the recorded images within the GUI includes
instructions for displaying a condensed view of all of the recorded
images.
22. The bedside controller of claim 16, wherein the instructions
for displaying the recorded images within the GUI includes
instructions for receiving gesture inputs through the
touch-sensitive display for navigation through the recorded
images.
23. The bedside controller of claim 16, wherein the plurality of
instructions includes instructions for annotating the image of
interest with the measurements.
24. The bedside controller of claim 23, wherein the plurality of
instructions includes instructions for saving to a processing
system the image of interest with the measurement annotations
thereon.
25. The bedside controller of claim 16, wherein the imaging tool is
a sensor disposed on a catheter within a vessel of the patient.
26. The bedside controller of claim 25, wherein the instructions
for initiating and terminating include instructions for
coordinating the recordation with a pullback of the catheter.
27. The bedside controller of claim 16, wherein the instructions
for making a measurement include instructions for selecting one of
an area measurement mode and a diameter measurement mode based on
the user measurement input.
28. The bedside controller of claim 16, wherein the instructions
for rendering a GUI on the touch-sensitive display include
instructions for providing haptic feedback in response to
touch-based input to the GUI.
29. The bedside controller of claim 16, wherein the instructions
for displaying the recorded images include instructions for
displaying a three-dimensional rendering of a portion of the
patient's body.
30. The bedside controller of claim 29, wherein the instructions
for displaying a three-dimensional rendering include: instructions
for receiving multiple concurrent touch inputs via the
touch-sensitive display; and instructions for rotating the
three-dimensional rendering about an axis based on the multiple
concurrent touch inputs.
Description
[0001] This application claims the benefit of U.S. provisional
patent application 61/560,677, filed Nov. 16, 2011, entitled
"MEDICAL SENSING CONTROL SYSTEM AND METHOD," the entirety of which
is incorporated by reference herein.
TECHNICAL FIELD
[0002] Embodiments of the present disclosure relate generally to
the field of medical devices and, more particularly, to a medical
workflow system and associated methods of use.
BACKGROUND
[0003] Innovations in diagnosing and verifying the level of success
of treatment of disease have progressed from solely external
imaging processes to include internal diagnostic processes. In
addition to traditional external image techniques such as X-ray,
MRI, CT scans, fluoroscopy, and angiography, small sensors may now
be placed directly in the body. For example, diagnostic equipment
and processes have been developed for diagnosing vasculature
blockages and other vasculature disease by means of ultra-miniature
sensors placed upon the distal end of a flexible elongate member
such as a catheter, or a guide wire used for catheterization
procedures. For example, known medical sensing techniques include
intravascular ultrasound (IVUS), forward looking IVUS (FL-IVUS),
fractional flow reserve (FFR) determination, a coronary flow
reserve (CFR) determination, optical coherence tomography (OCT),
trans-esophageal echocardiography, and image-guided therapy.
Traditionally, many of these procedures are carried out by a
multitude of physicians and clinicians, where each performs an
assigned task. For example, a physician may stand next to a patient
in the sterile field and guide the insertion and pull back of an
imaging catheter. A clinician near the physician may control the
procedure workflow with a controller, for example by starting and
stopping the capture of images. Further, after images have been
captured, a second clinician in an adjacent control room working at
a desktop computer may select the images of interest and make
measurements on them. Typically, the physician in the catheter lab
must instruct the clinician in the control room on how to make such
measurements. This may lengthen the time of the procedure, increase
the cost of the procedure, and may lead to measurement errors due
to miscommunication or clinician inexperience. Further, when making
measurements on medical sensing images, a clinician may typically
have to select a measurement mode prior to making any measurements,
reducing the efficiency of the medical sensing workflow.
[0004] Accordingly, while the existing devices and methods for
conducting medical sensing workflows have been generally adequate
for their intended purposes, they have not been entirely
satisfactory in all respects.
SUMMARY
[0005] In one exemplary aspect, the present disclosure is directed
to a method of conducting a medical workflow with a touch-sensitive
bedside controller. The method includes initiating a medical
workflow using a graphical user interface on the bedside
controller, positioning an imaging tool within a patient's body
based on images captured by the imaging tools and displayed on the
bedside controller, controlling the commencement and termination of
a recordation of images captured by the imaging tool using the
graphical user interface on the bedside controller, navigating
through the recorded images to identify an image of interest using
the graphical user interface on the bedside controller, and
performing measurements on the image of interest using the
graphical user interface on the bedside controller.
[0006] In some instances, the performing measurements may include
touching and releasing portions of the image of interest as it is
displayed on the bedside controller to make one of an area
measurement and a diameter measurement.
[0007] In another exemplary aspect, the present disclosure is
directed to a bedside controller. The bedside controller include a
housing, a touch-sensitive display disposed within a surface of the
housing and configured to display images and receive user input on
the surface, and a processor disposed within the housing. The
bedside controller also includes a communication module disposed
within the housing, communicatively coupled to the processor, and
configured to transmit and receive medical data and a
non-transitory computer readable storage module disposed within the
housing, communicatively coupled to the processor, and including a
plurality of instructions stored therein and executable by the
processor. The plurality of instructions include instructions for
rendering a graphical user interface (GUI) on the touch-sensitive
display, instructions for displaying images of a patient as they
are being captured by an imaging tool disposed within the patient's
body, and instructions for initiating and terminating a recordation
of the images based on user input to the GUI. The plurality of
instructions also include instructions for displaying the recorded
images within the GUI so that a user may identify an image of
interest and instructions for making a measurement on the image of
interest based on a user measurement input to the GUI.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 is a schematic drawing depicting a medical sensing
system including a bedside controller according to one embodiment
of the present disclosure.
[0009] FIG. 2 is a schematic drawing depicting a medical sensing
system including a wireless bedside controller according to another
embodiment of the present disclosure.
[0010] FIG. 3A is a diagrammatic perspective view of a bedside
controller.
[0011] FIG. 3B is a diagrammatic rear perspective view of the
bedside controller of FIG. 3A.
[0012] FIG. 3C is a diagrammatic perspective view of the bedside
controller of FIG. 3A mounted to a bed rail.
[0013] FIG. 4 is a functional block diagram of the bedside
controller of FIGS. 3A and 3B according to aspects of the present
disclosure.
[0014] FIG. 5 is a diagrammatic perspective view of a
multi-modality mobile processing system with the bedside controller
of FIGS. 3A and 3B attached thereto.
[0015] FIG. 6 is a diagrammatic perspective view of the bedside
controller of FIGS. 3A and 3B releasably mounted on an IV pole.
[0016] FIG. 7 is a high-level flowchart illustrating a method of
conducting a medical sensing workflow with a bedside controller
according to various aspects of the present disclosure.
[0017] FIG. 8 is high-level flowchart of a method that describes a
measurement workflow conducted on a bedside controller according to
various aspects of the present disclosure.
[0018] FIGS. 9-11 are partial screen images illustrating various
aspects of the method of FIG. 8.
DETAILED DESCRIPTION
[0019] For the purposes of promoting an understanding of the
principles of the present disclosure, reference will now be made to
the embodiments illustrated in the drawings, and specific language
will be used to describe the same. It will nevertheless be
understood that no limitation of the scope of the disclosure is
intended. Any alterations and further modifications in the
described devices, instruments, methods, and any further
application of the principles of the disclosure as described herein
are contemplated as would normally occur to one skilled in the art
to which the disclosure relates. In particular, it is fully
contemplated that the features, components, and/or steps described
with respect to one embodiment may be combined with the features,
components, and/or steps described with respect to other
embodiments of the present disclosure.
[0020] FIG. 1 is a schematic drawing depicting a medical sensing
system 100 including a bedside controller 102 according to one
embodiment of the present disclosure. In general, the medical
sensing system 100 provides for coherent integration and
consolidation of multiple forms of acquisition and processing
elements designed to be sensitive to a variety of methods used to
acquire and interpret human biological physiology and morphological
information. More specifically, in system 100, the bedside
controller 102 is a touch-enabled, integrated computing device for
the acquisition, control, interpretation, measurement, and display
of multi-modality medical sensing data. In the illustrated
embodiment, the bedside controller 102 is a tablet-style
touch-sensitive computer that provides user controls and diagnostic
images on a single surface. In the medical sensing system 100, the
bedside controller 102 is operable to present workflow control
options and patient image data via graphical user interfaces (GUIs)
corresponding to a plurality of medical sensing modalities. The
bedside controller 102 will be described in greater detail in
association with FIGS. 3A, 3B, and 4.
[0021] In the illustrated embodiment, the medical sensing system
100 is deployed in a catheter lab 104. The catheter lab 104 may be
used to perform on a patient 106 any number of medical sensing
procedures alone or in combination such as, by way of example and
not limitation, angiography, intravascular ultrasound (IVUS),
virtual histology (VH), forward looking IVUS (FL-IVUS),
intravascular photoacoustic (IVPA) imaging, fractional flow reserve
(FFR) determination, coronary flow reserve (CFR) determination,
optical coherence tomography (OCT), computed tomography,
intracardiac echocardiography (ICE), forward-looking ICE (FLICE),
intravascular palpography, transesophageal ultrasound, or any other
medical sensing modalities known in the art. In addition to
controlling medical sensing systems, the bedside controller may be
used to cooperate with and control medical treatment systems such
as, for example but without limitation, those used for stent
placement, coil embolism, ablation therapy, kidney stone
treatments, basket placement in a cystoscopy, tumor removal, and
chemical therapies. The catheter lab 104 further includes a sterile
field 105 that encompasses the portions of the catheter lab
surrounding the patient 106 on a procedure table 109 and a
clinician 107, who may perform any number of medical sensing
procedures or treatments. As shown in FIG. 1, the bedside
controller 102 may be positioned within the sterile field 105 and
may be utilized by the clinician 107 to control a workflow of a
medical sensing procedure or treatment being performed on the
patient 106. For example, the clinician 107 may initiate the
procedure workflow, watch real-time IVUS images captured during the
procedure, and make measurements on the IVUS images all using the
bedside controller 102 inside of the sterile field 105. In
alternative embodiments, the bedside controller 102 may be utilized
outside of the sterile field 105, for instance, in other locations
within the catheter lab 104 or in a control room adjacent to the
catheter lab. A method of utilizing the bedside controller 102 to
control a medical sensing workflow or treatment workflow will be
discussed in greater detail in association with FIGS. 7 and 8.
[0022] In the embodiment illustrated in FIG. 1, the medical sensing
system 100 additionally includes a number of interconnected medical
sensing-related tools in the catheter lab 104 to facilitate a
multi-modality workflow procedure, such as an IVUS catheter 108, an
IVUS patient isolation module (PIM) 112, an OCT catheter 110, and
OCT PIM 114, an electrocardiogram (ECG) device 116, an angiogram
system 117, a boom display 122, and a multi-modality processing
system 124. The bedside controller 102, PIMs 112 and 114, ECG
device 116, angiography system 117, and boom display 122 are
communicatively coupled to the processing system 124. In one
embodiment, the processing system 124 is a computer workstation
with the hardware and software to acquire, process, and display
multi-modality medical sensing data, but in other embodiments, the
processing system may be any other type of computing system
operable to process medical sensing data. For example, during an
IVUS workflow, the processing system 124 is operable to accept raw
IVUS data from the IVUS PIM 112, transform it into IVUS images, and
make the images available to the bedside controller 124, so that
they may be displayed to the clinician 107 for analysis. In the
embodiments in which the processing system 124 is a computer
workstation, the system includes at least a processor such as a
microcontroller or a dedicated central processing unit (CPU), a
non-transitory computer-readable storage medium such as a hard
drive, random access memory (RAM), and/or compact disk read only
memory (CD-ROM), a video controller such as a graphics processing
unit (GPU), and a network communication device such as an Ethernet
controller. Further, the multi-modality processing system 124 is
communicatively coupled to a data network 125. In the illustrated
embodiment, the data network 125 is a TCP/IP-based local area
network (LAN), however in other embodiments, it may utilize a
different protocol such as Synchronous Optical Networking (SONET),
or may be a wide area network (WAN). The processing system 124 may
connect to various resources via the network 125, such as a Digital
Imaging and Communications in Medicine (DICOM) system, a Picture
Archiving and Communication System (PACS), and a Hospital
Information System. U.S. Patent Application No. 61/473,570,
entitled "MULTI-MODALITY MEDICAL SENSING SYSTEM AND METHOD" and
filed on Apr. 8, 2011, discloses a multi-modality processing system
that processes medical sensing data and is hereby incorporated by
reference in its entirety.
[0023] In the medical sensing system 100, the IVUS PIM 112 and OCT
PIM 114 are operable to respectively receive medical sensing data
collected from the patient 106 by the IVUS catheter 108 and OCT
catheter 110 and are operable to transmit the received data to the
processing system 124. In one embodiment, the IVUS PIM 112 and OCT
PIM 114 transmit the medical sensing data over a Peripheral
Component Interconnect Express (PCIe) data bus connection, but, in
other embodiments, they may transmit data over a USB connection, a
Thunderbolt connection, a FireWire connection, or some other
high-speed data bus connection. Additionally, the ECG device 116 is
operable to transmit electrocardiogram signals or other hemodynamic
data from patient 106 to the processing system 124. To aid the
clinician in data capture, the bedside controller 102 is operable
to display the ECG data along side medical sensing data. Further,
in some embodiments, the processing system 124 may be operable to
synchronize data collection with the catheters 108 and 110 using
ECG signals from the ECG 116. Further, the angiogram system 117 is
operable to collect x-ray, computed tomography (CT), or magnetic
resonance images (MRI) of the patient 106 and transmit them to the
processing system 124. After the x-ray, CT, or MRI data has been
processed into human-readable images by the processing system 124,
the clinician 107 may navigate the GUI on the bedside controller
124 to retrieve the images from the processing system 124 and
display them on the controller. In some embodiments, the processing
system 124 may co-register image data from angiogram system 117
(e.g. x-ray data, MRI data, CT data, etc.) with sensing data from
the IVUS and OCT catheters 108 and 110. As one aspect of this, the
co-registration may be performed to generate three-dimensional
images with the sensing data. Such co-registered 3-D images data
may be viewable on the bedside controller 124. In one embodiment, a
clinician may rotate, zoom, and otherwise manipulate such 3-D
images on the bedside controller 102 using simultaneous touch
inputs (i.e. multitouch) and gestures.
[0024] Additionally, in the illustrated embodiment of FIG. 1,
medical sensing tools in system 100, are communicatively coupled to
the processing system 124 via a wired connection such as a standard
copper link or a fiber optic link. Specifically, the bedside
controller 124 may be communicatively and/or electrically coupled
to the processing system 124 via a Universal Serial Bus (USB)
connection, a Power-over-Ethernet connection, a Thunderbolt
connection, a FireWire connection, or some other high-speed data
bus connection.
[0025] However, in an alternative embodiment, such as that shown in
FIG. 2, the medical sensing tools may communicate wirelessly. In
that regard, FIG. 2 is a schematic drawing depicting a medical
sensing system 200 including a wireless bedside controller 202
according to another embodiment of the present disclosure. The
medical sensing system 200 is similar to the system 100 of FIG. 1
but the medical sensing tools including the wireless bedside
controller 202, a wireless IVUS PIM 204, and a wireless OCT PIM 206
communicate with a wireless network 208 via wireless networking
protocols. For example, the bedside controller 202 may send and
receive workflow control parameters, medical sensing images, and
measurement data to and from a remote processing system via IEEE
802.11 Wi-Fi standards, Ultra Wide-Band (UWB) standards, wireless
FireWire, wireless USB, Bluetooth, or another high-speed wireless
networking standard. Such wireless capability allows the clinician
107 to more freely position the bedside controller 202 inside or
outside of the sterile field 105 for better workflow
management.
[0026] With reference now to FIGS. 3A, 3B, 3C and 4, FIG. 3A is a
diagrammatic perspective view of a bedside controller 300, FIG. 3B
is a diagrammatic rear perspective view of the bedside controller,
FIG. 3C is a diagrammatic perspective view of the bedside
controller mounted to a bed rail, and FIG. 4 is a functional block
diagram of the bedside controller 300 according to aspects of the
present disclosure. The bedside controller 300 is similar to the
bedside controllers 102 and 202 in medical sensing systems 100 and
200, and is operable to, among other things, initiate a medical
sensing or treatment procedure workflow, display real-time images
captured during the procedure, accept measurement input on the
images from a clinician. The bedside controller 300 generally
improves system control available to a clinician working at a
patient table. For instance, giving a clinician both workflow
control and measurement capability within the sterile field reduces
errors and improves workflow efficiency.
[0027] As show in FIG. 3A, the bedside controller 300 includes an
integrally formed housing 302 that is easy to grasp and move around
a catheter lab or other medical setting. In one embodiment, the
integrally formed housing 302 may be seamlessly molded from
materials such as thermoplastic or thermosetting plastic or
moldable metal. In other embodiments, the integrally formed housing
302 may comprise a plurality of housing portions fixedly bonded in
a substantially permanent manner to form an integral housing. The
housing 302 is resistant to fluids, and, in one embodiment, may
have a rating of IPX4 against fluid ingress as defined by the
International Electrotechnical Commission (IEC) standard 60529. In
other embodiments in which the housing 302 may be used in different
environments, the hub may have a different fluid ingress rating. In
the illustrated embodiment, the housing 302 is about 10.5 inches in
width, about 8.25 inches in height, and has as thickness of about
2.75 inches. In alternative embodiments, the housing may have a
different width, height, or thickness that is similarly conducive
to portability.
[0028] As shown in FIG. 3B, the housing 302 further includes
self-contained mounting structure 303 disposed on the housing. In
the illustrated embodiment, the mounting structure is disposed near
an outer edge of the housing. The mounting structure 303 allows the
bedside controller 300 to be releasably mounted in a variety of
places in and out of a catheter lab in a self-contained manner.
That is, the bedside controller 300 may be directly secured to
another object without the use of a separate external mount. In the
illustrated embodiment, the mounting structure 303 includes a
mounting channel 304 and a retaining clamp 305 that pivots over the
mounting channel to secure a mounting platform therewithin. The
mounting channel 304 is defined by a longer front wall 350, a top
wall 352, and a shorter back wall 354, and the retaining clamp
includes a slot 356 that extends through the clamp in a manner
generally parallel to the mounting channel. The front wall 350 and
the back wall 354 are generally perpendicular to a touch-sensitive
display 307 in the housing 302, and the top wall 352 is generally
parallel to the display 307. In the illustrated embodiment, the
retaining clamp is spring-loaded and releasably exerts pressure on
objects situated in the mounting channel. In alternative
embodiments, the retaining clamp may be configured differently and
exert force via mechanisms other than springs.
[0029] As shown in FIG. 3C, in operation, the bedside controller
300 may be releasably secured to a mounting platform, for example a
bed rail 306, by pivoting the mounting clamp 305 to an open
position, positioning the controller such that the rail extends
through the length of the channel 304, and releasing the clamp such
that it secures the rail within the channel. When the rail 306 is
positioned in the mounting channel 304 and the clamp 305 is holding
it therein, three surfaces of the rail are respectively engaged by
the front wall 350, the top wall 352, and the back wall 354, and a
fourth surface of the rail extends through the slot 356 in the
clamp 305. In this manner, the mounting structure 303 may maintain
the bedside controller 300 in a position generally parallel to a
procedure table 350 associated with the bed rail 306, as shown in
FIG. 3B. Described differently, the mounting structure 303 is a
cantilevered mounting structure in that it secures one end of the
controller to an object while the majority of the controller
extends away from the object in an unsupported manner. Such a
cantilevered position allows for a display of the controller to be
both readable and at a comfortable input angle for an operator.
Further, the self-contained mounting structure 303 allows the
bedside controller 300 to be quickly released from the bed rail 306
and reattached to an IV pole, a cart on which a processing system
is deployed, or other location in or out of the sterile field to
allow for convenient workflow control and image analysis. In
alternative embodiments the mounting structure 303 of the bedside
controller may vary from the design illustrated in FIGS. 3A and 3B
and include additional and/or different components to allow for
self-contained mounting.
[0030] Embedded into the front of the housing 302 is the
touch-sensitive display 307 that comprises both a touch panel 308
and a flat panel display 309. The touch panel 308 overlays the flat
panel display 308 and accepts user input via human touch, stylus
touch, or some other analogous input method. In other words, the
touch-sensitive display 307 displays images and accepts user input
on the same surface. In the current embodiment, the touch panel 308
is a resistive-type panel, but in alternative embodiments it may be
a capacitive-type panel, projective-type panel, or some other
suitable type of touch enabled input panel. Further, the touch
panel 308 is operable to accept multiple inputs simultaneously
(multitouch), for instance, to enable rotation of a
three-dimensional rendering of a vessel along multiple axes.
Additionally, the touch panel 308 is capable of receiving input
when a sterile drape 301 is covering the bedside controller 300 and
also when a user is gloved. The touch panel 308 is controlled by a
touch controller 310 disposed within the housing 302. Further, when
a clinician makes contact with the touch panel 308, the touch panel
is operable to provide haptic feedback via a haptics controller 312
and haptics drivers 314. This haptic technology is operable to
simulate a plurality of sensations on the touch panel 308 by
varying the intensity and frequency of vibrations generated when a
user contacts the touch panel. In some embodiments, the housing 302
may include a sheath configured to store a stylus therein. Thus, a
clinician may remove the stylus from the sheath in the housing to
make measurements on the bedside controller and store it when the
measurements have been completed.
[0031] Beneath the touch panel 308 is the flat panel display 309
that presents a graphical user interface (GUI) 316 to a user. In
the illustrated embodiment, the flat panel display 309 is a LCD
display but in alternative embodiments, it may be a different type
of display such an LED display or an AMOLED display. In the
illustrated embodiment, the flat panel display 309 is illuminated
by a LED backlight power inverter 318. As mentioned above, the GUI
316 not only allows a clinician to control a medical sensing
workflow but also make measurements on images captured from a
patient in the sterile field. A method of interacting with the GUI
316 to make vessel measurements will be discussed in greater detail
in association with FIGS. 8-11.
[0032] The bedside controller 300 includes a single board
processing platform 320 within the housing 302 that is operable to
render the GUI 316 and process user input. In the illustrated
embodiment, the processing platform has a pico form factor and
includes integrated processing components such as a processor 321,
system memory 322, graphics processing unit (GPU), communications
module 323, and I/O bus controller. In some embodiments, the
processor 321 may be a low power processor such as an Intel
Atom.RTM. processor or a ARM-based processor, and the
communications module 323 may be a 10/100/1 Gb Ethernet module.
And, the I/O bus controller may be a Universal Serial Bus (USB)
controller. The bedside controller 300 further includes a storage
module 324 that is a non-transitory computer readable storage
medium operable to store an operating system (i.e. software to
render and control the GUI), image manipulation software, medical
sensing data and images received from a processing system, and
other medical sensing-related software. The processor 321 is
configured to execute software and instructions stored on the
storage module 324. In the illustrated embodiment, the storage
module 324 is a solid state drive (SSD) hard drive communicatively
coupled to the processing platform 320 via a SATA connection, but,
in alternative embodiments, it may be any other type of
non-volatile or temporary storage module. The bedside controller
300 further includes a wireless communications module 326
communicatively coupled to the processing platform 320. In some
embodiments, the wireless communications module is a IEEE 802.11
Wi-Fi module, but in other may be a Ultra Wide-Band (UWB) wireless
module, a wireless FireWire module, a wireless USB module, a
Bluetooth module, or another high-speed wireless networking
module.
[0033] In the illustrated embodiment, the bedside controller 300 is
powered via both a wired 12 VDC power-over-Ethernet (PoE)
connection 328 and a battery 330 disposed within the housing 302.
In one embodiment, the battery 330 may be sealed within the
integrally formed housing 302 and may be recharged through
electrical contacts disposed on the exterior of the housing and
electrically coupled to the battery. As shown in the embodiment of
FIG. 3B, the front wall 350 may include one or more electrical
contacts 358 through which the battery 330 may be charged when the
controller is mounted to objects with compatible charging
structure. In other embodiments, the housing 302 may include a
battery compartment with a removable cover to permit battery
replacement. Such a battery compartment cover may be resistant to
fluid ingress (e.g., with an IPX4 rating). The beside controller
300 may be coupled to a processing system in the catheter lab via
the PoE connection 328, over which it receives medical sensing
images that have been captured from the patient and rendered on the
processing system. In operation, when the bedside controller is
coupled to the PoE connection 328, it receives power and
communications over the same physical wire. When the bedside
controller 300 is disconnected from the PoE connection 328, it runs
on battery power and receives data wirelessly via the wireless
communications module 326. When used wirelessly in a catheter lab,
the beside controller may directly communicate with a processing
system (i.e. in an ad-hoc wireless mode), or, alternatively, it may
communicate with a wireless network that serves a plurality of
wireless devices. In alternative embodiments, the bedside
controller 300 may receive power and data through different wired
connections, or receive data communications through a wired data
connection and power from the battery 330, or receive data
communications through the wireless module 326 and power from a
wired electrical connection. In some embodiments, the bedside
controller 300 may be used in a semi-wireless configuration, in
which the battery 330 provides backup power to the controller when
the controller is temporarily disconnected from a wired power
source. For example, if at the beginning of a procedure, the
bedside controller 300 is connected to a PoE connection (or other
type of wired connection) and during the procedure the controller
must be disconnected from the PoE connection to allow for a cabling
adjustment, the battery 330 may keep the controller alive until a
PoE connection can be re-established. In this manner, a full
power-off and reboot of the controller 300 is avoided during a
procedure. As shown in FIG. 4, a DC-DC power converter 332 converts
input voltage to a voltage usable by the processing platform
320.
[0034] It is understood that although the bedside controller 300 in
the illustrated embodiments of FIGS. 3 and 4 includes specific
components described herein, the bedside controller may include any
number of additional components, for example a charge regulator
interposed between the electrical contacts and the battery, and may
be configured in any number of alternative arrangements in
alternative embodiments.
[0035] With reference now to FIGS. 5 and 6, illustrated are
examples of locations in which the bedside controller 300 may be
mounted. FIG. 5 is a diagrammatic perspective view of a
multi-modality mobile processing system 500. The processing system
500 is disposed on a cart 502 that enables the processing system to
be easily moved between different locations such as different
catheter labs. As shown in FIG. 5, the bedside controller 300 is
mounted to the cart 502 so that it may be transported to catheter
labs with the processing system. The bedside controller 300 is
releasably secured to the cart via the self-contained mounting
structure 303 that is built into the housing 302. Further, in some
embodiments, the cart 502 may include a dock for the bedside
controller 300 such that when the controller is docked on the cart
its battery is recharged through the electrical contacts 358
disposed on the housing 302. As shown in FIG. 6, the bedside
controller 300 may also releasably attach to an IV pole 600 via the
self-contained mounting structure 303. When so attached, the
bedside controller 300 may be rolled next to a patient in the
sterile field and thus within reach of a clinician who may operate
the controller with a single hand.
[0036] FIG. 7 is a high-level flowchart illustrating a method 700
of conducting a medical sensing workflow with the bedside
controller 300 of FIGS. 3-4 according to various aspects of the
present disclosure. The method 700 will be described in the context
of an IVUS procedure but may equally apply to any number of medical
sensing or treatment procedures, such as an OCT procedure, a FLIVUS
procedure, an ICE procedure, etc. The method 700 begins at block
702 where a medical sensing workflow is initiated with the bedside
controller 300. Using an IVUS procedure as an example, a clinician
in the sterile field and adjacent a patient may select the "IVUS"
option out of a plurality of modes (e.g., OCT, Chromaflow, FLIVUS,
etc) on the bedside controller's GUI to begin the IVUS workflow.
Next, in block 704, after an IVUS imaging catheter has been
inserted into the patient, the clinician may select a `Live Images`
option on the bedside controller's GUI to receive live images from
the catheter. Using the real-time images, the clinician may guide
the catheter within the patient to a desired position. In typical
embodiments, a processing system may collect raw IVUS data from the
catheter and process the data to render IVUS images. The bedside
controller retrieves the IVUS images from the processing system and
displays them to a user in real-time. Then, in block 706, after the
IVUS catheter has been appropriately positioned in the patient
using the live images, the clinician selects a `Record` option on
the bedside controller GUI and begins the catheter pull back. The
processing system responds to the record command and begins
rendering and storing IVUS images. The method 700 proceeds to block
708 where, after the IVUS catheter pull back has been completed,
the clinician terminates the recording of IVUS images via the
bedside controller's GUI. Then, in block 710, the clinician at the
bedside recalls the captured IVUS images on the bedside controller
and finds the IVUS images associated with the area of interest.
Specifically, the bedside controller may present a condensed view
of all captured images and the clinician may navigate through them
using gestures on the bedside controller's touch panel to find the
target area. Finally, in block 720, the clinician performs
measurements on the IVUS images directly on the bedside controller.
The user of the bedside controller creates measurements by
interacting with an image through a series of presses, moves and
releases using a finger or stylus on the controller's
touch-sensitive display. These actions are interpreted by the
bedside controller's internal processor and converted to
measurements on the display. For precise measurements, the
clinician may annotate the images using a stylus or another tool
compatible with the bedside controller's touch panel. After the
appropriate measurements have been completed, the clinician may
save the images to the processing system by selecting the
appropriate options in the bedside controller GUI. A method of
performing measurements on the bedside controller will be described
below.
[0037] FIG. 8 is high-level flowchart of a method 800 that
describes a measurement workflow on the bedside controller 300 of
FIGS. 3A-4. In one embodiment, the method 800 may be carried out
during block 720 of the method 700 in FIG. 7 as part of a medical
sensing workflow on intravascular images. Further, in the
illustrated embodiment, the method 800 of making measurements on
the bedside controller 300 is implemented in measurement software
stored in the storage module 324 in the bedside controller. In
general, when measuring images, such as intravascular images, a
clinician has the option of making different types of measurements
such as diameter measurements and area measurements. Typically,
when making area measurements, a clinician may either denote the
edges of an object by drawings a series of discrete points that are
connected in subsequent processing or by drawing a continuous line
around the object to the measured. In this regard, the method 800
of performing measurements on images is "smart" in that it does not
require a user to select a particular measurement mode prior to
interacting with an image on the bedside controller. For instance,
when a user performs a series of measurement inputs on the bedside
controller, the GUI software interprets the nature (e.g. shape) of
a user's measurement inputs, automatically enters either diameter
mode, area-point mode or area-draw mode, and outputs the desired
measurement on the controller's display.
[0038] In more detail, the method 800 begins at block 802 where an
image to be measured is displayed on the bedside controller and a
user inputs a measurement start point on the image with an input
device. For example, the user may use a finger or stylus to
indicate a point on a vessel border from which a measurement will
commence. Note that prior to selecting the measurement start point,
the measurement software did not require the user to select a
measurement mode. Next, in block 804, the user, without removing
the input device from the image after indicating the start point,
drags the input device across the image a distance to trace a line.
Then, in block 806, the user withdraws the input device from the
image at a measurement end point. The method 800 proceeds to
decision block 808 where the measurement software determines
whether the distance between the start point and the end point is
less than a threshold value. In one embodiment, the threshold value
is equivalent to 10 pixels, but, in alternative embodiments, the
threshold value may be smaller or larger or measured in different
units. Further, in some embodiments, the threshold value is
adjustable either manually by a user or automatically based on
detected error rates. If the distance is less than the threshold
value, the method proceeds to block 810 where the measurement
software enters area-point mode and draws a point on the image
corresponding to the end point (i.e. where the user lifted the
input device from the touch-enabled display). This sequence is
illustrated in FIG. 9. Specifically, when a user presses (900) an
input device on an image and immediately lifts (902) the input
device, the input will be interpreted as a point entry and a point
904 will be drawn on the image.
[0039] The method 800 then proceeds to decision block 812 where it
is decided whether additional points are needed to make a
measurement on the image. If additional points are needed, the
method proceeds to block 814 where a user touches and releases the
displayed image at a different location. Note that in this branch
of method 800, the measurement software is in area-point mode so
that all entries will be interpreted as points and, when an input
is detected, a point will be drawn on the image in block 810
regardless of the distance between a start point and end point of
the input. If no additional points are needed to make a measurement
in decision block 812, the method 800 proceeds to block 816, where
a user selects a `Done` button in the bedside controller GUI to
exit area-point mode. In block 818, the measurement software
creates an area measurement using the entered points. For example,
in an embodiment directed toward vessel measurement, the
measurement software connects the entered points to create a
bounding circle at the vessel's outer edge. In one embodiment, the
measurement software uses the entered points as seed points to
assist edge detection algorithms.
[0040] With reference back to decision block 808, if the distance
between the start point and the end point is greater than or equal
to the threshold, the method 800 proceeds to decision block 820
where the measurement software determines whether the drawn line is
"relatively straight". That is, it determines whether the user
desires to measure a diameter with a line or an area with an
enclosed shape. As shown in FIG. 10, to make such a determination,
the measurement software compares intervening points on the traced
line between a start point 1000 and an end point 1002 against a
boundary threshold 1004. If all intervening points are within the
boundary threshold 1004, the measurement software determines that
the user desires to make a diameter measurement and transforms the
traced line into a straight line 1006 extending from the start
point to the end point. The diameter measurement is thus based on
the length of the straight line 1006. In alternative embodiments,
however, the measurement software may employ different methods for
determining whether the user desires to make a diameter measurement
or an area measurement, such as detecting whether intervening
points between start and end points increase in distance from the
start point before decreasing in distance from the start point or
detecting whether the traced line extending through the start
point, at least one intervening point, and the end point is arcuate
past a threshold degree. At decision block 820, if the user's
traced line is relatively straight, the method proceeds to block
822 where the measurement software enters diameter mode and outputs
a measurement of the straight line 1006 created between the start
and end points. If, however, the traced line is not relatively
straight, the method 800 proceeds to 818 where the measurement
software enters area-draw mode. As shown in FIG. 11, the traced
line 1100 between start point 1102 and end point 1104 extends
outside of a boundary threshold (not shown) and is thus not
relatively straight, prompting the measurement software to enter
area-draw mode. Once this determination is made, the software
connects the start and ends points to create an unbroken bounding
line 1006 from which an area may be calculated. After an area
measurement has been made in block 818 (either in area-point mode
or area-draw mode), the method proceeds to decision block 824 where
it is determined if another measurement needs to be done. If so,
the method proceeds back to block 802 where a user selects another
start point on the image without first selecting a measurement
mode. If all measurements have been completed, the method 800
ends.
[0041] It is understood that the methods 700 and 800 illustrated in
the flow charts of FIGS. 7 and 8 may, in alternative embodiments,
be performed in a different order and may include different and/or
additional blocks in some embodiments. For example, workflows for
some medical sensing procedure may allow for additional measurement
modes, such as volumetric measurements. According to the described
aspects of the present disclosure, a user may initiate any such
additional measurement modes without first selecting a measurement
mode, thus simplifying the workflow. Further, the steps in methods
700 and 800 described above may be completed over the course of
more than one patient visit to a catheter lab.
[0042] Although illustrative embodiments have been shown and
described, a wide range of modification, change, and substitution
is contemplated in the foregoing disclosure and in some instances,
some features of the present disclosure may be employed without a
corresponding use of the other features. For example, in some
embodiments, the touch-enabled integrated bedside controllers 102
and 300 may be used to control and measure non-cardiovascular
diagnostic data such as data from cranial or peripheral arteries,
as well as data from non-vascular body portions. Further, the
controllers 102 and 300 may be used to control an MRI workflow and
measure MRI image data, or may be utilized in computer assisted
surgery (CAS) applications. Further, the modules described above in
association with the bedside controller 300 may be implemented in
hardware, software, or a combination of both. And the bedside
controller may be designed to enable user control in many different
network settings such as ad-hoc networks, local area networks,
client-server networks, wide area networks, internets, and the
controller may have a number of form factors such as a tablet, a
smartphone, a laptop, or any other similar device. It is understood
that such variations may be made in the foregoing without departing
from the scope of the present disclosure. Accordingly, it is
appropriate that the appended claims be construed broadly and in a
manner consistent with the scope of the present disclosure.
* * * * *