U.S. patent application number 17/668777 was filed with the patent office on 2022-05-26 for devices systems and methods for coronary intervention assessment, planning, and treatment based on desired outcome.
The applicant listed for this patent is IMPERIAL INNOVATIONS LIMITED. Invention is credited to Justin DAVIES.
Application Number | 20220160429 17/668777 |
Document ID | / |
Family ID | |
Filed Date | 2022-05-26 |
United States Patent
Application |
20220160429 |
Kind Code |
A1 |
DAVIES; Justin |
May 26, 2022 |
DEVICES SYSTEMS AND METHODS FOR CORONARY INTERVENTION ASSESSMENT,
PLANNING, AND TREATMENT BASED ON DESIRED OUTCOME
Abstract
The present disclosure relates generally to the assessment and
treatment of vessels, including for percutaneous coronary
intervention (PCI) and coronary artery bypass grafting (CABG). For
example, some embodiments of the present disclosure are suited for
identifying the available intervention technique(s) suitable to
achieve a desired outcome selected or input by a user. For example,
in some implementations a method comprises receiving pressure
measurements obtained by one or more intravascular pressure-sensing
instruments positioned within a vessel of a patient; receiving an
input from a user regarding a desired pressure value for the vessel
of the patient; identifying an available treatment option based on
the received pressure measurements and the desired pressure value;
and outputting, to a display device, a screen display including a
visual representation of the available treatment option. Related
devices and systems are also described.
Inventors: |
DAVIES; Justin; (LONDON,
GB) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
IMPERIAL INNOVATIONS LIMITED |
London |
|
GB |
|
|
Appl. No.: |
17/668777 |
Filed: |
February 10, 2022 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
15764865 |
Mar 29, 2018 |
11246661 |
|
|
PCT/IB2016/055788 |
Sep 28, 2016 |
|
|
|
17668777 |
|
|
|
|
62234441 |
Sep 29, 2015 |
|
|
|
International
Class: |
A61B 34/10 20060101
A61B034/10; A61B 5/0215 20060101 A61B005/0215; A61B 5/00 20060101
A61B005/00; A61B 6/00 20060101 A61B006/00; A61B 17/22 20060101
A61B017/22; A61F 2/82 20060101 A61F002/82; G16H 10/60 20060101
G16H010/60; G16H 20/30 20060101 G16H020/30; G16H 30/20 20060101
G16H030/20; G16H 40/20 20060101 G16H040/20; G16H 50/50 20060101
G16H050/50; A61B 5/02 20060101 A61B005/02 |
Claims
1. A system, comprising: a processor configured for communication
with an intravascular pressure-sensing guidewire and a display
device, wherein the processor is configured to: receive pressure
measurements obtained by the intravascular pressure-sensing
guidewire while the intravascular pressure-sensing guidewire is
positioned within a blood vessel of the patient; output, to the
display device, a screen display comprising a plurality of
treatment option fields representative of a plurality of available
treatment options; receive, via the plurality of treatment option
fields, a user input comprising a selection of one or more
treatment options, of the plurality of available treatment options,
that are under consideration for treatment of the blood vessel,
wherein, after the user input is received, the one or more
treatment options that are under consideration are displayed
differently than the plurality of available treatment options; and
determine, based on the pressure measurements, whether the one or
more treatment options that are under consideration satisfy a
treatment planning related pressure value, wherein the screen
display further comprises a visual representation associated with
the determination of whether the one or more treatment options that
are under consideration satisfy the treatment planning related
pressure value.
2. The system of claim 1, wherein the treatment planning related
pressure value comprises at least one of a desired pressure value
or a minimum pressure value.
3. The system of claim 1, wherein the screen display comprises a
treatment planning related pressure field, wherein the processor is
further configured to receive, via the treatment planning related
pressure field, a further user input comprising the treatment
planning related pressure value, and wherein, after the further
user input is received, the treatment planning related pressure
value is displayed in the treatment planning related pressure
field.
4. The system of claim 1, wherein the one or more treatment options
that are under consideration comprise a first treatment option,
wherein, to determine whether the one or more treatment options
that are under consideration satisfy the treatment planning related
pressure value, the processor is configured to determine, based on
the pressure measurements, a first corrected pressure value
expected to result from the first treatment option, and wherein the
visual representation comprises a first visual representation of
the first corrected pressure value.
5. The system of claim 4, wherein the one or more treatment options
that are under consideration comprises a second treatment option
different than the first treatment option, wherein, to determine
whether the one or more treatment options that are under
consideration satisfy the treatment planning related pressure
value, the processor is configured to determine, based on the
pressure measurements, a second corrected pressure value expected
to result from the second treatment option, wherein the visual
representation comprises a second visual representation of the
second corrected pressure value, and wherein the first visual
representation and the second visual representation are displayed
simultaneously.
6. The system of claim 5, wherein the visual representation
comprises a third visual representation of the treatment planning
related pressure value, wherein the third visual representation is
displayed simultaneously with the first and second visual
representation.
7. The system of claim 6, wherein the screen display simultaneously
provides an evaluation of the first treatment option and the second
treatment option based on a visual comparison of the first
corrected pressure value, the second corrected pressure value, and
the treatment planning related pressure value.
8. The system of claim 5, wherein the first treatment option and
the second treatment option comprise a same treatment type with
different parameters values.
9. The system of claim 8, wherein the same treatment type comprises
stenting, wherein the different parameters values correspond to at
least one of stent length, stent diameter, or stent material.
10. The system of claim 1, wherein the processor is further
configured to receive an x-ray image of the vessel, wherein the
visual representation comprises the x-ray image.
11. The system of claim 11, wherein the visual representation
comprises a visual representation of the one or more treatment
options under consideration overlaid on the vessel in the x-ray
image.
12. The system of claim 11, wherein the visual representation of
the one or more treatment options comprises a stent at a deployment
location of the vessel in the x-ray image.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 15/764,865, filed on Mar. 29, 2018, now U.S.
Pat. No. 11,246,661, which is the U.S. National Phase application
under 35 U.S.C. .sctn. 371 of International Application No.
PCT/M2016/055788, filed on Sep. 28, 2016, which claims the benefit
of U.S. Provisional Patent Application No. 62/234,441, filed on
Sep. 29, 2015. These applications are hereby incorporated by
reference herein.
TECHNICAL FIELD
[0002] The present disclosure relates generally to the assessment
and treatment of vessels, including for percutaneous coronary
intervention (PCI) and coronary artery bypass grafting (CABG). For
example, some embodiments of the present disclosure are suited for
identifying the available intervention technique(s) suitable to
achieve a desired outcome. In some instances, a user selects or
inputs one or more parameters of the desired outcome.
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.
[0004] One exemplary type of procedure involves pressure
measurements within a blood vessel. A currently accepted technique
for assessing the severity of a stenosis in the blood vessel,
including ischemia causing lesions, is fractional flow reserve
(FFR). FFR is a calculation of the ratio of a distal pressure
measurement (taken on the distal side of the stenosis) relative to
a proximal pressure measurement (taken on the proximal side of the
stenosis). FFR provides an index of stenosis severity that allows
determination as to whether the blockage limits blood flow within
the vessel to an extent that treatment is required. The normal
value of FFR in a healthy vessel is 1.00, while values less than
about 0.80 are generally deemed significant and require treatment.
Another technique for assessing blood vessels utilizes Instant
Wave-Free Ratio.TM. Functionality (iFR.RTM. Functionality) (both
trademarks of Volcano Corp.), which includes the determination of a
pressure ratio across a stenosis during the wave-free period, when
resistance is naturally constant and minimized in the cardiac
cycle. The iFR modality does not require administration of a
hyperemic agent. The normal value of iFR in a healthy vessel is
1.00, while values less than about 0.89 are generally deemed
significant and require treatment.
[0005] When an occluded blood vessel that requires treatment is
identified, a percutaneous coronary intervention (PCI) is a
therapeutic procedure that can be utilized to treat the vessel. A
PCI includes angioplasty and positioning a stent across the
stenosis to open the vessel. Clinicians conventionally rely on
angiography and physiologic measurements of pressure and/or flow,
which are not meaningfully connected, to plan a therapeutic
intervention. Planning the therapeutic intervention can include
selecting various parameters related to the stent, such as
positioning, length, diameter, etc. Because it is difficult to
integrate the various sources of data, there is difficulty in
developing the therapeutic plan. Further, there is little ability
to predict the efficacy of the therapeutic intervention based on
the available data. For example, a clinician conventionally cannot
determine, with a clinical certainty that is supported by the
collected data, what the effect of changing the positioning and/or
length of a stent is on the efficacy of the stent placement.
[0006] Accordingly, there remains a need for improved devices,
systems, and methods for assessing the severity of a blockage in a
vessel and, in particular, a stenosis in a blood vessel. There also
remains a need for improved devices, systems, and methods for
planning a PCI by connecting the angiography and physiologic data
in a way that allows clinicians to efficiently plan and evaluate
the proposed therapy. Further, there remains a need for providing
visual depictions of a vessel and a proposed therapeutic
intervention, such as a stent, in the vessel that allow a clinician
to plan, evaluate, and change the proposed therapy in a manner
supported by the collected physiologic data.
SUMMARY
[0007] Embodiments of the present disclosure are configured to
provide devices, systems, and methods for the assessment and
treatment of vessels, including for percutaneous coronary
intervention (PCI) and coronary artery bypass grafting (CABG), that
achieve a desired outcome. In some instances, a user selects or
inputs one or more parameters of the desired outcome.
[0008] In an exemplary embodiment, a method includes receiving
pressure measurements obtained by one or more intravascular
pressure-sensing instruments positioned within a vessel of a
patient; receiving an input from a user regarding a desired
pressure value for the vessel of the patient; identifying an
available treatment option based on the received pressure
measurements and the desired pressure value; and outputting, to a
display device, a screen display including a visual representation
of the available treatment option.
[0009] In some embodiments, the method further includes receiving
angiography data obtained simultaneously with the pressure
measurements. The visual representation of the available treatment
option can include a graphical overlay on the angiographic image.
The received pressure measurements can include proximal pressure
measurements and distal pressure measurements and the desired
pressure value can be a pressure ratio, such as FFR, iFR, Pd/Pa,
compensated Pd/Pa, compensated iFR, or other ratio. In that regard,
the pressure ratio can be calculated as a function of the distal
pressure measurements relative to the proximal pressure
measurements. In some instances, the received pressure measurements
are obtained without use of a hyperemic agent. The method can
further include receiving an input from the user regarding one or
more treatment types to consider for the available treatment
option. The one or more treatment types can include at least one of
an angioplasty, a stent, a coronary artery bypass graft, or a
pharmaceutical. The method can include identifying a stent
deployment location within the vessel. The method can also include
identifying at least one stent parameter selected from the group
consisting of stent length, stent diameter, and stent material.
[0010] In some embodiments, the method further includes performing
the available treatment option. The method can also include
receiving additional pressure measurements obtained by one or more
intravascular pressure-sensing instruments positioned within the
vessel of the patient after performing the available treatment
option. In that regard, the method can determine whether a pressure
value based on the additional pressure measurements meets the
desired pressure value for the vessel of the patient. For example,
the desired pressure value can be a threshold value for a pressure
ratio of distal pressure measurements relative to proximal pressure
measurements. The method can further include identifying a second
available treatment option based on the received additional
pressure measurements and the desired pressure value if the
pressure value based on the additional pressure measurements does
not meet the desired pressure value for the vessel of the
patient.
[0011] In some embodiments, a system includes a processing system
communicatively coupled to one or more intravascular
pressure-sensing devices and a display device, the processing
system configured to: receive pressure measurements obtained by the
one or more intravascular pressure-sensing instruments positioned
within a vessel of a patient; receive an input from a user
regarding a desired pressure value for the vessel of the patient;
identify an available treatment option based on the received
pressure measurements and the desired pressure value; and output,
to a display device, a screen display including a visual
representation of the available treatment option.
[0012] In some embodiments, the processing system is further
configured to receive angiography data obtained simultaneously with
the pressure measurements. The visual representation of the
available treatment option can include a graphical overlay on the
angiographic image. The received pressure measurements can include
proximal pressure measurements and distal pressure measurements and
the desired pressure value can be a pressure ratio, such as FFR,
iFR, Pd/Pa, compensated Pd/Pa, compensated iFR, or other ratio. The
pressure ratio can be calculated as a function of the distal
pressure measurements relative to the proximal pressure
measurements. In some instances, the received pressure measurements
are obtained without use of a hyperemic agent.
[0013] The processing system can be further configured to receive
an input from the user regarding one or more treatment types to
consider for the available treatment option. In some
implementations, the one or more treatment types include at least
one of an angioplasty, a stent, a coronary artery bypass graft, or
a pharmaceutical. The processing system can be configured to
identify the available treatment option by identifying a stent
deployment location within the vessel. The processing system can
also be configured to identify the available treatment option by
identifying at least one stent parameter selected from the group
consisting of stent length, stent diameter, and stent material.
[0014] In some instances, the processing system can be configured
to receive additional pressure measurements obtained by one or more
intravascular pressure-sensing instruments positioned within the
vessel of the patient after performance of the available treatment
option. The processing system can be configured to determine
whether a pressure value based on the additional pressure
measurements meets the desired pressure value for the vessel of the
patient. In some instances, the desired pressure value is a
threshold value for a pressure ratio of distal pressure
measurements relative to proximal pressure measurements. The
processing system can also be configured to identify a second
available treatment option based on the received additional
pressure measurements and the desired pressure value if the
pressure value based on the additional pressure measurements does
not meet the desired pressure value for the vessel of the patient.
In some instances, the system further includes the one or more
intravascular pressure-sensing devices.
[0015] Additional aspects, features, and advantages of the present
disclosure will become apparent from the following detailed
description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] Illustrative embodiments of the present disclosure will be
described with reference to the accompanying drawings, of
which:
[0017] FIG. 1 is a diagrammatic perspective view of a vessel having
a stenosis according to an embodiment of the present
disclosure.
[0018] FIG. 2 is a diagrammatic, partial cross-sectional
perspective view of a portion of the vessel of FIG. 1 taken along
section line 2-2 of FIG. 1.
[0019] FIG. 3 is a diagrammatic, partial cross-sectional
perspective view of the vessel of FIGS. 1 and 2 with instruments
positioned therein according to an embodiment of the present
disclosure.
[0020] FIG. 4 is a diagrammatic, schematic view of a system
according to an embodiment of the present disclosure.
[0021] FIG. 5 is a flow diagram of a method of evaluating and
treating a vessel of a patient according to an embodiment of the
present disclosure.
[0022] FIG. 6 is a screen display according to an embodiment of the
present disclosure.
[0023] FIG. 7 is a screen display according to another embodiment
of the present disclosure.
[0024] FIG. 8 is a screen display according to another embodiment
of the present disclosure.
[0025] FIG. 9 is a screen display according to another embodiment
of the present disclosure.
[0026] FIG. 10 is a screen display according to another embodiment
of the present disclosure.
[0027] FIG. 11 is a screen display according to another embodiment
of the present disclosure.
[0028] FIG. 12 is a screen display according to another embodiment
of the present disclosure.
DETAILED DESCRIPTION
[0029] 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 is nevertheless understood
that no limitation to the scope of the disclosure is intended. Any
alterations and further modifications to the described devices,
systems, and methods, and any further application of the principles
of the present disclosure are fully contemplated and included
within the present disclosure 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. For the sake of
brevity, however, the numerous iterations of these combinations
will not be described separately.
[0030] Referring to FIGS. 1 and 2, shown therein is a vessel 100
having a stenosis according to an embodiment of the present
disclosure. In that regard, FIG. 1 is a diagrammatic perspective
view of the vessel 100, while FIG. 2 is a partial cross-sectional
perspective view of a portion of the vessel 100 taken along section
line 2-2 of FIG. 1. Referring more specifically to FIG. 1, the
vessel 100 includes a proximal portion 102 and a distal portion
104. A lumen 106 extends along the length of the vessel 100 between
the proximal portion 102 and the distal portion 104. In that
regard, the lumen 106 is configured to allow the flow of fluid
through the vessel. In some instances, the vessel 100 is a blood
vessel. In some particular instances, the vessel 100 is a coronary
artery. In such instances, the lumen 106 is configured to
facilitate the flow of blood through the vessel 100.
[0031] As shown, the vessel 100 includes a stenosis 108 between the
proximal portion 102 and the distal portion 104. Stenosis 108 is
generally representative of any blockage or other structural
arrangement that results in a restriction to the flow of fluid
through the lumen 106 of the vessel 100. Embodiments of the present
disclosure are suitable for use in a wide variety of vascular
applications, including without limitation coronary, peripheral
(including but not limited to lower limb, carotid, and
neurovascular), renal, and/or venous. Where the vessel 100 is a
blood vessel, the stenosis 108 may be a result of plaque buildup,
including without limitation plaque components such as fibrous,
fibro-lipidic (fibro fatty), necrotic core, calcified (dense
calcium), blood, fresh thrombus, and mature thrombus. Generally,
the composition of the stenosis will depend on the type of vessel
being evaluated. In that regard, it is understood that the concepts
of the present disclosure are applicable to virtually any type of
blockage or other narrowing of a vessel that results in decreased
fluid flow.
[0032] Referring more particularly to FIG. 2, the lumen 106 of the
vessel 100 has a diameter 110 proximal of the stenosis 108 and a
diameter 112 distal of the stenosis. In some instances, the
diameters 110 and 112 are substantially equal to one another. In
that regard, the diameters 110 and 112 are intended to represent
healthy portions, or at least healthier portions, of the lumen 106
in comparison to stenosis 108. Accordingly, these healthier
portions of the lumen 106 are illustrated as having a substantially
constant cylindrical profile and, as a result, the height or width
of the lumen has been referred to as a diameter. However, it is
understood that in many instances these portions of the lumen 106
will also have plaque buildup, a non-symmetric profile, and/or
other irregularities, but to a lesser extent than stenosis 108 and,
therefore, will not have a cylindrical profile. In such instances,
the diameters 110 and 112 are understood to be representative of a
relative size or cross-sectional area of the lumen and do not imply
a circular cross-sectional profile.
[0033] As shown in FIG. 2, stenosis 108 includes plaque buildup 114
that narrows the lumen 106 of the vessel 100. In some instances,
the plaque buildup 114 does not have a uniform or symmetrical
profile, making angiographic evaluation of such a stenosis
unreliable. In the illustrated embodiment, the plaque buildup 114
includes an upper portion 116 and an opposing lower portion 118. In
that regard, the lower portion 118 has an increased thickness
relative to the upper portion 116 that results in a non-symmetrical
and non-uniform profile relative to the portions of the lumen
proximal and distal of the stenosis 108. As shown, the plaque
buildup 114 decreases the available space for fluid to flow through
the lumen 106. In particular, the cross-sectional area of the lumen
106 is decreased by the plaque buildup 114. At the narrowest point
between the upper and lower portions 116, 118 the lumen 106 has a
height 120, which is representative of a reduced size or
cross-sectional area relative to the diameters 110 and 112 proximal
and distal of the stenosis 108. Note that the stenosis 108,
including plaque buildup 114 is exemplary in nature and should be
considered limiting in any way. In that regard, it is understood
that the stenosis 108 has other shapes and/or compositions that
limit the flow of fluid through the lumen 106 in other instances.
While the vessel 100 is illustrated in FIGS. 1 and 2 as having a
single stenosis 108 and the description of the embodiments below is
primarily made in the context of a single stenosis, it is
nevertheless understood that the devices, systems, and methods
described herein have similar application for a vessel having
multiple stenosis regions.
[0034] Referring now to FIG. 3, the vessel 100 is shown with
instruments 130 and 132 positioned therein according to an
embodiment of the present disclosure. In general, instruments 130
and 132 may be any form of device, instrument, or probe sized and
shaped to be positioned within a vessel. In the illustrated
embodiment, instrument 130 is generally representative of a guide
wire, while instrument 132 is generally representative of a
catheter. In that regard, instrument 130 extends through a central
lumen of instrument 132. However, in other embodiments, the
instruments 130 and 132 take other forms. In that regard, the
instruments 130 and 132 are of similar form in some embodiments.
For example, in some instances, both instruments 130 and 132 are
guide wires. In other instances, both instruments 130 and 132 are
catheters. On the other hand, the instruments 130 and 132 are of
different form in some embodiments, such as the illustrated
embodiment, where one of the instruments is a catheter and the
other is a guide wire. Further, in some instances, the instruments
130 and 132 are disposed coaxial with one another, as shown in the
illustrated embodiment of FIG. 3. In other instances, one of the
instruments extends through an off-center lumen of the other
instrument. In yet other instances, the instruments 130 and 132
extend side-by-side. In some particular embodiments, at least one
of the instruments is as a rapid-exchange device, such as a
rapid-exchange catheter. In such embodiments, the other instrument
is a buddy wire or other device configured to facilitate the
introduction and removal of the rapid-exchange device. Further
still, in other instances, instead of two separate instruments 130
and 132 a single instrument is utilized. In some embodiments, the
single instrument incorporates aspects of the functionalities
(e.g., data acquisition) of both instruments 130 and 132.
[0035] Instrument 130 is configured to obtain diagnostic
information about the vessel 100. In that regard, the instrument
130 includes one or more sensors, transducers, and/or other
monitoring elements configured to obtain the diagnostic information
about the vessel. The diagnostic information includes one or more
of pressure, flow (velocity and/or volume), images (including
images obtained using ultrasound (e.g., IVUS), OCT, thermal, and/or
other imaging techniques), temperature, and/or combinations
thereof. The one or more sensors, transducers, and/or other
monitoring elements are positioned adjacent a distal portion of the
instrument 130 in some instances. In that regard, the one or more
sensors, transducers, and/or other monitoring elements are
positioned less than 30 cm, less than 10 cm, less than 5 cm, less
than 3 cm, less than 2 cm, and/or less than 1 cm from a distal tip
134 of the instrument 130 in some instances. In some instances, at
least one of the one or more sensors, transducers, and/or other
monitoring elements is positioned at the distal tip of the
instrument 130.
[0036] The instrument 130 includes at least one element configured
to monitor pressure within the vessel 100. The pressure monitoring
element can take the form a piezo-resistive pressure sensor, a
piezo-electric pressure sensor, a capacitive pressure sensor, an
electromagnetic pressure sensor, a fluid column (the fluid column
being in communication with a fluid column sensor that is separate
from the instrument and/or positioned at a portion of the
instrument proximal of the fluid column), an optical pressure
sensor, and/or combinations thereof. In some instances, one or more
features of the pressure monitoring element are implemented as a
solid-state component manufactured using semiconductor and/or other
suitable manufacturing techniques. Examples of commercially
available guide wire products that include suitable pressure
monitoring elements include, without limitation, the Verrata.RTM.
pressure guide wire, the PrimeWire Prestige.RTM. PLUS pressure
guide wire, and the ComboWire.RTM. XT pressure and flow guide wire,
each available from Volcano Corporation, as well as the
PressureWire.TM. Certus guide wire and the PressureWire.TM. Aeris
guide wire, each available from St. Jude Medical, Inc. Generally,
the instrument 130 is sized such that it can be positioned through
the stenosis 108 without significantly impacting fluid flow across
the stenosis, which would impact the distal pressure reading.
Accordingly, in some instances the instrument 130 has an outer
diameter of 0.018'' or less. In some embodiments, the instrument
130 has an outer diameter of 0.014'' or less. In some embodiments,
the instrument 130 has an outer diameter of 0.035'' or less.
[0037] Instrument 132 is also configured to obtain diagnostic
information about the vessel 100. In some instances, instrument 132
is configured to obtain the same diagnostic information as
instrument 130. In other instances, instrument 132 is configured to
obtain different diagnostic information than instrument 130, which
may include additional diagnostic information, less diagnostic
information, and/or alternative diagnostic information. The
diagnostic information obtained by instrument 132 includes one or
more of pressure, flow (velocity and/or volume), images (including
images obtained using ultrasound (e.g., IVUS), OCT, thermal, and/or
other imaging techniques), temperature, and/or combinations
thereof. Instrument 132 includes one or more sensors, transducers,
and/or other monitoring elements configured to obtain this
diagnostic information. In that regard, the one or more sensors,
transducers, and/or other monitoring elements are positioned
adjacent a distal portion of the instrument 132 in some instances.
In that regard, the one or more sensors, transducers, and/or other
monitoring elements are positioned less than 30 cm, less than 10
cm, less than 5 cm, less than 3 cm, less than 2 cm, and/or less
than 1 cm from a distal tip 136 of the instrument 132 in some
instances. In some instances, at least one of the one or more
sensors, transducers, and/or other monitoring elements is
positioned at the distal tip of the instrument 132.
[0038] Similar to instrument 130, instrument 132 also includes at
least one element configured to monitor pressure within the vessel
100. The pressure monitoring element can take the form a
piezo-resistive pressure sensor, a piezo-electric pressure sensor,
a capacitive pressure sensor, an electromagnetic pressure sensor, a
fluid column (the fluid column being in communication with a fluid
column sensor that is separate from the instrument and/or
positioned at a portion of the instrument proximal of the fluid
column), an optical pressure sensor, and/or combinations thereof.
In some instances, one or more features of the pressure monitoring
element are implemented as a solid-state component manufactured
using semiconductor and/or other suitable manufacturing techniques.
Currently available catheter products suitable for use with one or
more of Siemens AXIOM Sensis, Mennen Horizon XVu, and Philips Xper
IM Physiomonitoring 5 and include pressure monitoring elements can
be utilized for instrument 132 in some instances.
[0039] In accordance with aspects of the present disclosure, at
least one of the instruments 130 and 132 is configured to monitor a
pressure within the vessel 100 distal of the stenosis 108 and at
least one of the instruments 130 and 132 is configured to monitor a
pressure within the vessel proximal of the stenosis. In that
regard, the instruments 130, 132 are sized and shaped to allow
positioning of the at least one element configured to monitor
pressure within the vessel 100 to be positioned proximal and/or
distal of the stenosis 108 as necessary based on the configuration
of the devices. In that regard, FIG. 3 illustrates a position 138
suitable for measuring pressure distal of the stenosis 108. In that
regard, the position 138 is less than 5 cm, less than 3 cm, less
than 2 cm, less than 1 cm, less than 5 mm, and/or less than 2.5 mm
from the distal end of the stenosis 108 (as shown in FIG. 2) in
some instances. FIG. 3 also illustrates a plurality of suitable
positions for measuring pressure proximal of the stenosis 108. In
that regard, positions 140, 142, 144, 146, and 148 each represent a
position that is suitable for monitoring the pressure proximal of
the stenosis in some instances. In that regard, the positions 140,
142, 144, 146, and 148 are positioned at varying distances from the
proximal end of the stenosis 108 ranging from more than 20 cm down
to about 5 mm or less. Generally, the proximal pressure measurement
will be spaced from the proximal end of the stenosis. Accordingly,
in some instances, the proximal pressure measurement is taken at a
distance equal to or greater than an inner diameter of the lumen of
the vessel from the proximal end of the stenosis. In the context of
coronary artery pressure measurements, the proximal pressure
measurement is generally taken at a position proximal of the
stenosis and distal of the aorta, within a proximal portion of the
vessel. However, in some particular instances of coronary artery
pressure measurements, the proximal pressure measurement is taken
from a location inside the aorta. In other instances, the proximal
pressure measurement is taken at the root or ostium of the coronary
artery.
[0040] In some embodiments, at least one of the instruments 130 and
132 is configured to monitor pressure within the vessel 100 while
being moved through the lumen 106. In some instances, instrument
130 is configured to be moved through the lumen 106 and across the
stenosis 108. In that regard, the instrument 130 is positioned
distal of the stenosis 108 and moved proximally (i.e., pulled back)
across the stenosis to a position proximal of the stenosis in some
instances. In other instances, the instrument 130 is positioned
proximal of the stenosis 108 and moved distally across the stenosis
to a position distal of the stenosis. Movement of the instrument
130, either proximally or distally, is controlled manually by
medical personnel (e.g., hand of a surgeon) in some embodiments. In
other embodiments, movement of the instrument 130, either
proximally or distally, is controlled automatically by a movement
control device (e.g., a pullback device, such as the Trak Back.RTM.
II Device available from Volcano Corporation). In that regard, the
movement control device controls the movement of the instrument 130
at a selectable and known speed (e.g., 2.0 mm/s, 1.0 mm/s, 0.5
mm/s, 0.2 mm/s, etc.) in some instances. Movement of the instrument
130 through the vessel is continuous for each pullback or push
through, in some instances. In other instances, the instrument 130
is moved step-wise through the vessel (i.e., repeatedly moved a
fixed amount of distance and/or a fixed amount of time). Some
aspects of the visual depictions discussed below are particularly
suited for embodiments where at least one of the instruments 130
and 132 is moved through the lumen 106. Further, in some particular
instances, aspects of the visual depictions discussed below are
particularly suited for embodiments where a single instrument is
moved through the lumen 106, with or without the presence of a
second instrument.
[0041] The instruments 130 and/or 132 can be used to conduct
medical sensing procedures associated with Instant Wave-Free
Ratio.TM. Functionality (iFR.RTM. Functionality) (both trademarks
of Volcano Corp.) and those disclosed in U.S. patent application
Ser. No. 13/460,296, entitled "DEVICES, SYSTEMS, AND METHODS FOR
ASSESSING A VESSEL," hereby incorporated by reference in its
entirety, which discloses the use of pressure ratios that are
available without application of a hyperemic agent. Further,
medical sensing procedures associated with compensated Pd/Pa ratios
suitable for estimating iFR.RTM., FFR, and/or other accepted
diagnostic pressure ratios as disclosed in U.S. Provisional Patent
Application No. 62/024,005, filed Jul. 14, 2014 and entitled
"DEVICES, SYSTEMS, AND METHODS FOR TREATMENT OF VESSELS," which is
hereby incorporated by reference in its entirety, can be conducted
using the instruments 130 and/or 132.
[0042] Referring now to FIG. 4, shown therein is a system 150
according to an embodiment of the present disclosure. In that
regard, FIG. 4 is a diagrammatic, schematic view of the system 150.
As shown, the system 150 includes an instrument 152. In that
regard, in some instances instrument 152 is suitable for use as at
least one of instruments 130 and 132 discussed above.
[0043] Accordingly, in some instances the instrument 152 includes
features similar to those discussed above with respect to
instruments 130 and 132 in some instances. In the illustrated
embodiment, the instrument 152 is a guide wire having a distal
portion 154 and a housing 156 positioned adjacent the distal
portion. In that regard, the housing 156 is spaced approximately 3
cm from a distal tip of the instrument 152. The housing 156 is
configured to house one or more sensors, transducers, and/or other
monitoring elements configured to obtain the diagnostic information
about the vessel. In the illustrated embodiment, the housing 156
contains at least a pressure sensor configured to monitor a
pressure within a lumen in which the instrument 152 is positioned.
A shaft 158 extends proximally from the housing 156. A torque
device 160 is positioned over and coupled to a proximal portion of
the shaft 158. A proximal end portion 162 of the instrument 152 is
coupled to a connector 164. A cable 166 extends from connector 164
to a connector 168. In some instances, connector 168 is configured
to be plugged into an interface 170. In that regard, interface 170
is a patient interface module (PIM) in some instances. In some
instances, the cable 166 is replaced with a wireless connection. In
that regard, it is understood that various communication pathways
between the instrument 152 and the interface 170 may be utilized,
including physical connections (including electrical, optical,
and/or fluid connections), wireless connections, and/or
combinations thereof.
[0044] The interface 170 is communicatively coupled to a computing
device 172 via a connection 174. Computing device 172 is generally
representative of any device suitable for performing the processing
and analysis techniques discussed within the present disclosure. In
some embodiments, the computing device 172 includes a processor,
random access memory, and a storage medium. In that regard, in some
particular instances the computing device 172 is programmed to
execute steps associated with the data acquisition and analysis
described herein. Accordingly, it is understood that any steps
related to data acquisition, data processing, instrument control,
and/or other processing or control aspects of the present
disclosure may be implemented by the computing device using
corresponding instructions stored on or in a non-transitory
computer readable medium accessible by the computing device. In
some instances, the computing device 172 is a console device. In
some particular instances, the computing device 172 is similar to
the s5.TM. Imaging System or the s5i.RTM. Imaging System, each
available from Volcano Corporation. In some instances, the
computing device 172 is portable (e.g., handheld, on a rolling
cart, etc.). In some instances, all or a portion of the computing
device 172 can be implemented as a bedside controller such that one
or more processing steps described herein can be performed by
processing component(s) of the bedside controller. An exemplary
bedside controller is described in U.S. Provisional Application No.
62/049,265, titled "Bedside Controller for Assessment of Vessels
and Associated Devices, Systems, and Methods," and filed Sep. 11,
2014, the entirety of which is hereby incorporated by reference
herein. Further, it is understood that in some instances the
computing device 172 comprises a plurality of computing devices. In
that regard, it is particularly understood that the different
processing and/or control aspects of the present disclosure may be
implemented separately or within predefined groupings using a
plurality of computing devices. Any divisions and/or combinations
of the processing and/or control aspects described below across
multiple computing devices are within the scope of the present
disclosure.
[0045] Together, connector 164, cable 166, connector 168, interface
170, and connection 174 facilitate communication between the one or
more sensors, transducers, and/or other monitoring elements of the
instrument 152 and the computing device 172. However, this
communication pathway is exemplary in nature and should not be
considered limiting in any way. In that regard, it is understood
that any communication pathway between the instrument 152 and the
computing device 172 may be utilized, including physical
connections (including electrical, optical, and/or fluid
connections), wireless connections, and/or combinations thereof. In
that regard, it is understood that the connection 174 is wireless
in some instances. In some instances, the connection 174 includes a
communication link over a network (e.g., intranet, internet,
telecommunications network, and/or other network). In that regard,
it is understood that the computing device 172 is positioned remote
from an operating area where the instrument 152 is being used in
some instances. Having the connection 174 include a connection over
a network can facilitate communication between the instrument 152
and the remote computing device 172 regardless of whether the
computing device is in an adjacent room, an adjacent building, or
in a different state/country. Further, it is understood that the
communication pathway between the instrument 152 and the computing
device 172 is a secure connection in some instances. Further still,
it is understood that, in some instances, the data communicated
over one or more portions of the communication pathway between the
instrument 152 and the computing device 172 is encrypted.
[0046] The system 150 also includes an instrument 175. In that
regard, in some instances instrument 175 is suitable for use as at
least one of instruments 130 and 132 discussed above. Accordingly,
in some instances the instrument 175 includes features similar to
those discussed above with respect to instruments 130 and 132 in
some instances. In the illustrated embodiment, the instrument 175
is a catheter-type device. In that regard, the instrument 175
includes one or more sensors, transducers, and/or other monitoring
elements adjacent a distal portion of the instrument configured to
obtain the diagnostic information about the vessel. In the
illustrated embodiment, the instrument 175 includes a pressure
sensor configured to monitor a pressure within a lumen in which the
instrument 175 is positioned. The instrument 175 is in
communication with an interface 176 via connection 177. In some
instances, interface 176 is a hemodynamic monitoring system or
other control device, such as Siemens AXIOM Sensis, Mennen Horizon
XVu, and Philips Xper IM Physiomonitoring 5. In one particular
embodiment, instrument 175 is a pressure-sensing catheter that
includes fluid column extending along its length. In such an
embodiment, interface 176 includes a hemostasis valve fluidly
coupled to the fluid column of the catheter, a manifold fluidly
coupled to the hemostasis valve, and tubing extending between the
components as necessary to fluidly couple the components. In that
regard, the fluid column of the catheter is in fluid communication
with a pressure sensor via the valve, manifold, and tubing. In some
instances, the pressure sensor is part of interface 176. In other
instances, the pressure sensor is a separate component positioned
between the instrument 175 and the interface 176. The interface 176
is communicatively coupled to the computing device 172 via a
connection 178.
[0047] The computing device 172 is communicatively coupled to a
display device 180 via a connection 182. In some embodiments, the
display device 172 is a component of the computing device 172,
while in other embodiments, the display device 172 is distinct from
the computing device 172. In some embodiments, the display device
172 is implemented as a bedside controller having a touch-screen
display as described, for example, in U.S. Provisional Application
No. 62/049,265, titled "Bedside Controller for Assessment of
Vessels and Associated Devices, Systems, and Methods," and filed
Sep. 11, 2014, the entirety of which is hereby incorporated by
reference herein. The computing device 172 can generate screen
displays including data collected by the instruments 152 and 175
and other instruments, quantities computed based on the collected
data, visualizations of the vessel in which the data is collected,
and visualizations based on the collected data and computed
quantities. Exemplary screen displays are illustrated in FIGS.
7-28. The computing device 172 can provide the display data
associated with the screen displays to the display device 180.
[0048] The computing device 172 can additionally be communicatively
coupled to a user interface device. The user interface device
permits a user to interact with the screen displays on the display
device 180. For example, the user can provide a user input to
modify all or a portion of the screen display using the user
interface device. Exemplary user inputs and the corresponding
modifications to the screen display are illustrated in FIGS. 7-28.
In some embodiments, the user interface device is a separate
component from the display device 180. In other embodiments, the
user interface device is part of the display device 180. For
example, the user interface device can be implemented as a bedside
controller having a touch-screen display as described, for example,
in U.S. Provisional Application No. 62/049,265, titled "Bedside
Controller for Assessment of Vessels and Associated Devices,
Systems, and Methods," and filed Sep. 11, 2014, the entirety of
which is hereby incorporated by reference herein. In such
embodiments, a user input can be a touch input received on the
touch sensitive display of the bedside controller.
[0049] Similar to the connections between instrument 152 and the
computing device 172, interface 176 and connections 177 and 178
facilitate communication between the one or more sensors,
transducers, and/or other monitoring elements of the instrument 175
and the computing device 172. However, this communication pathway
is exemplary in nature and should not be considered limiting in any
way. In that regard, it is understood that any communication
pathway between the instrument 175 and the computing device 172 may
be utilized, including physical connections (including electrical,
optical, and/or fluid connections), wireless connections, and/or
combinations thereof. In that regard, it is understood that the
connection 178 is wireless in some instances. In some instances,
the connection 178 includes a communication link over a network
(e.g., intranet, internet, telecommunications network, and/or other
network). In that regard, it is understood that the computing
device 172 is positioned remote from an operating area where the
instrument 175 is being used in some instances. Having the
connection 178 include a connection over a network can facilitate
communication between the instrument 175 and the remote computing
device 172 regardless of whether the computing device is in an
adjacent room, an adjacent building, or in a different
state/country. Further, it is understood that the communication
pathway between the instrument 175 and the computing device 172 is
a secure connection in some instances. Further still, it is
understood that, in some instances, the data communicated over one
or more portions of the communication pathway between the
instrument 175 and the computing device 172 is encrypted.
[0050] It is understood that one or more components of the system
150 are not included, are implemented in a different
arrangement/order, and/or are replaced with an alternative
device/mechanism in other embodiments of the present disclosure.
For example, in some instances, the system 150 does not include
interface 170 and/or interface 176. In such instances, the
connector 168 (or other similar connector in communication with
instrument 152 or instrument 175) may plug into a port associated
with computing device 172. Alternatively, the instruments 152, 175
may communicate wirelessly with the computing device 172. Generally
speaking, the communication pathway between either or both of the
instruments 152, 175 and the computing device 172 may have no
intermediate nodes (i.e., a direct connection), one intermediate
node between the instrument and the computing device, or a
plurality of intermediate nodes between the instrument and the
computing device.
[0051] In some embodiments, the system 150 can additionally include
a bedside controller, such as the bedside controller described in
U.S. Provisional Application No. 62/049,265, titled "Bedside
Controller for Assessment of Vessels and Associated Devices,
Systems, and Methods," and filed Sep. 11, 2014, the entirety of
which is hereby incorporated by reference herein. The bedside
controller may be utilized by a clinician to control instruments
152 and 175 to acquire pressure data during a procedure, watch
real-time medical pressure measurements (e.g., visual
representations of pressure data, such as pressure waveforms,
numerical values, etc.), compute pressure ratio(s) based on the
collected pressure data, and interact with the obtained medical
sensing data, a visual representation of the obtained medical
sensing data and/or computed pressure ratio(s), a visualization
based on the obtained medical sensing data and/or computed pressure
ratio(s), and/or a visual representation of the vessel 100. In that
regard, the bedside controller can be communicatively coupled to
the computing device 172, the interfaces 170 and 176, and/or the
instruments 152 and 175.
[0052] In some embodiments, the system 150 can include an inventory
database 190 associated with a clinical environment, such as a
hospital or other healthcare facility at which a treatment would be
carried out on a patient. The inventory database can store various
data about the treatment options that are available to a clinician
for use at the healthcare facility based on medical equipment,
inventory, operating room and/or catheter lab availability, staff
availability, etc. For example, in some instances the data can
include information about the coronary stents available to the
clinician, including such information as manufacturer names,
length, diameter, material(s), quantity available, quantity
available for immediate use, resupply frequency, next shipment
date, treatment outcomes for various patient types, and other
suitable information. As described below, the computing device 172
can compile a plurality of available treatment options based on the
inventory database 190 and a desired outcome input/selected by the
clinician via a user interface. In some instances, the desired
outcome is a threshold and/or target value for a pressure
measurement, such as a pressure ratio (FFR, iFR, Pd/Pa, etc.) or
pressure measurement (e.g., Pd, etc.). The computing device 172 can
automatically recommend a particular treatment (e.g., performing
angioplasty and deploying a stent from a particular manufacturer,
with a particular length, diameter, and/or material, at particular
location(s) within the vessel) by performing treatment planning
using pressure measurements, flow measurements, angiography images,
and/or other diagnostic information about the patient. The
computing device 172 can also receive a user input selecting
particular treatment options for consideration (or to be excluded
from consideration), which may be based on clinician preference or
other factors. The computing device 172 is communicatively coupled
to the inventory database 190 via a connection 192. The connection
192 can be representative of one or more network connections that
communicatively couple the computing device 172 with a computing
system of the healthcare facility.
[0053] Diagnostic information within a vasculature of interest can
be obtained using one or more of instruments 130, 132, 152, and
175. For example, diagnostic information is obtained for one or
more coronaries arteries, peripheral arteries, cerebrovascular
vessels, etc. The diagnostic information can include
pressure-related values, flow-related values, etc. Pressure-related
values can include FFR (e.g., a pressure ratio value calculated as
a first instrument is moved through a vessel relative to a second
instrument, including across at least one stenosis of the vessel),
Pd/Pa (e.g., a ratio of the pressure distal to a lesion to the
pressure proximal to the lesion), iFR (e.g., a pressure ratio value
calculated using a diagnostic window relative to a distance as a
first instrument is moved through a vessel relative to a second
instrument, including across at least one stenosis of the vessel),
etc. Flow-related values can include coronary flow reserve or CFR
(e.g., maximum increase in blood flow through the coronary arteries
above the normal resting volume), basal stenosis resistance index
(BSR), etc.
[0054] The diagnostic information and/or data obtained by
instruments 130, 132, 152, and/or 175 are correlated or
co-registered to angiographic image(s) and/or other two-dimensional
or three-dimensional depictions of a patient's vasculature obtained
by an external imaging system. In various embodiments, the
diagnostic information obtained by the external imaging system can
include externally-obtained angiographic images, x-ray images, CT
images, PET images, MRI images, SPECT images, and/or other
two-dimensional or three-dimensional extraluminal depictions of a
patient's vasculature. Spatial co-registration can be completed
using techniques disclosed in U.S. Pat. No. 7,930,014, titled
"VASCULAR IMAGE CO-REGISTRATION," which is hereby incorporated by
reference in its entirety, based on the known pullback
speed/distance, based on a known starting point, based on a known
ending point, and/or combinations thereof. For example, a
mechanical pullback device can be used to conduct the
pressure-sensing procedure. The mechanical pullback device can move
the pressure-sensing device through the vessel at a fixed, known
rate. The location of the pressure measurements and/or the pressure
ratio(s) can be determined based on the rate of the pullback and a
known location of the pressure-sensing device (e.g., a start
position, a mid-point position, an end position, available from
angiography data). In some embodiments, diagnostic information
and/or data is correlated to vessel images using techniques similar
to those described in U.S. Provisional Patent Application No.
61/747,480, titled "SPATIAL CORRELATION OF INTRAVASCULAR IMAGES AND
PHYSIOLOGICAL FEATURES" and filed Dec. 31, 2012, which is hereby
incorporated by reference in its entirety. In some embodiments,
co-registration and/or correlation can be completed as described in
U.S. Provisional Patent Application No. 61/856,509, titled
"DEVICES, SYSTEMS, AND METHODS FOR ASSESSMENT OF VESSELS" and filed
Jul. 19, 2013, which is hereby incorporated by reference in its
entirety.
[0055] In some embodiments, diagnostic information and/or data is
correlated to vessel images using techniques similar to those
described in U.S. patent application Ser. No. 14/144,280, titled
"DEVICES, SYSTEMS, AND METHODS FOR ASSESSMENT OF VESSELS" and filed
Dec. 31, 2012, which is hereby incorporated by reference in its
entirety. In some embodiments, co-registration and/or correlation
can be completed as described in U.S. Provisional Patent
Application No. 61/856,509, titled "DEVICES, SYSTEMS, AND METHODS
FOR ASSESSMENT OF VESSELS" and filed Jul. 19, 2013, which is hereby
incorporated by reference in its entirety. In other embodiments,
co-registration and/or correlation can be completed as described in
International Application No. PCT/IL2011/000612, titled "CO-USE OF
ENDOLUMINAL DATA AND EXTRALUMINAL IMAGING" and filed Jul. 28, 2011,
which is hereby incorporated by reference in its entirety. Further,
in some embodiments, co-registration and/or correlation can be
completed as described in International Application No.
PCT/IL2009/001089, titled "IMAGE PROCESSING AND TOOL ACTUATION FOR
MEDICAL PROCEDURES" and filed Nov. 18, 2009, which is hereby
incorporated by reference in its entirety. Additionally, in other
embodiments, co-registration and/or correlation can be completed as
described in U.S. patent application Ser. No. 12/075,244, titled
"IMAGING FOR USE WITH MOVING ORGANS" and filed Mar. 10, 2008, which
is hereby incorporated by reference in its entirety.
[0056] FIG. 5 is flowchart illustrating a method 500 of evaluating
a vessel of a patient. The method 500 will be described in the
context of a pressure-sensing procedure, such as an iFR, Pd/Pa, or
FFR procedure. It is understood that the method 500 can be carried
out in the context of a flow-sensing procedure, such as a CFR
procedure. The method 500 can be better understood with reference
to FIGS. 6-12. In that regard, the user interface displays of FIGS.
6-12 can be displayed on a display device of system assessing a
patient's vasculature, such as the display device 180 associated
with computing device 172 (FIG. 4). That is, one or more components
(e.g., a processor and/or processing circuit) of the system (e.g.,
computing device 172) can provide display data to cause the
interfaces of FIGS. 6-12 to be shown on a display device (e.g.,
display device 180). It is understood that the aspects of FIGS.
6-12 may be shown alone or along with other data, images, and/or
other information about the patient/vessel(s) of interest.
[0057] At block 510, the method 500 includes obtaining
intravascular measurements, such as pressure and/or flow
measurements. At block 520, the method 500 includes acquiring
angiography data. In some embodiments, the pressure measurements
are obtained simultaneously as the angiography data is acquired.
Simultaneously collecting pressure measurements and angiography
data can facilitate co-registration, as described above. For
example, the collected pressure data can be co-registered such that
the location of the pressure sensing component of the intravascular
device within the vessel is known. A processing system can
associate the location with the pressure measurements and/or the
pressure ratio(s) at that location. The processing system can also
generate a screen display including the pressure measurements
and/or pressure ratios at their associated locations, as described
below with respect to FIGS. 6-8.
[0058] To facilitate obtaining the pressure measurements, a
clinician can insert pressure-sensing intravascular device(s), such
as a catheter or guidewire, into the patient. In some embodiments,
the clinician may guide the intravascular device within the patient
to a desired position using the angiography data. After the
pressure sensing intravascular device has been appropriately
positioned in the patient, the clinician can initiate collection of
pressure measurements. Pressure measurements can be collected
during one or more of the following procedures: an FFR "spot"
measurement where the pressure sensor stays in one place while
hyperemia is induced; an FFR pullback in which an elongated period
of hyperemia is induced and the sensor is pulled back to the
ostium; an iFR "spot" measurement that is similar to the FFR spot
measurement but without hyperemia; and an iFR pullback which is
that the FFR pullback but without hyperemia. In various
embodiments, physiological measurement collection can be carried
through a combination of one or more of the procedures described
above. Physiological measurement can be continuous, such as during
a pullback procedure. Physiological measurements can occur while
the intravascular device is moved in one direction. Measurement
collection can be discontinuous procedure, such as when the
intravascular device is selectively moved through the vessel (e.g.,
when movement of the intravascular device starts and stops, when
the intravascular device is held at various points along the vessel
longer than others, etc.). Physiological measurements can occur
while the intravascular device is moved in both directions (e.g.,
proximally and distally within the blood vessel). Co-registration
can be used to ensure that, regardless of how the physiological
measurements were collected, the location of the measurement can be
identified on an angiographic image of the vessel. For example, a
composite of the collected physiological measurements can be
generated based on the co-registered data.
[0059] In that regard, in some instances the pressure measurements
are representative of a pressure ratio between a fixed location
within the vessel and the moving position of the instrument as the
instrument is moved through the vessel. For example, in some
instances a proximal pressure measurement is obtained at a fixed
location within the vessel while the instrument is pulled back
through the vessel from a first position distal of the position
where the proximal pressure measurement is obtained to a second
position more proximal than the first position (i.e., closer to the
fixed position of the proximal pressure measurement). For clarity
in understanding the concepts of the present disclosure, this
arrangement will be utilized to describe many of the embodiments of
the present disclosure. However, it is understood that the concepts
are equally applicable to other arrangements. For example, in some
instances, the instrument is pushed through the vessel from a first
position distal of the proximal pressure measurement location to a
second position further distal (i.e., further away from the fixed
position of the proximal pressure measurement). In other instances,
a distal pressure measurement is obtained at a fixed location
within the vessel and the instrument is pulled back through the
vessel from a first position proximal of the fixed location of the
distal pressure measurement to a second position more proximal than
the first position (i.e., further away from the fixed position of
the distal pressure measurement). In still other instances, a
distal pressure measurement is obtained at a fixed location within
the vessel and the instrument is pushed through the vessel from a
first position proximal of the fixed location of the distal
pressure measurement to a second position less proximal than the
first position (i.e., closer the fixed position of the distal
pressure measurement).
[0060] In typical embodiments, a processing system can collect raw
pressure data from the intravascular device and process the data to
compute pressure differential(s) or ratio(s). The pressure
differential between the two pressure measurements within the
vessel (e.g., a fixed location pressure measurement and a moving
pressure measurement) is calculated as a ratio of the two pressure
measurements (e.g., the moving pressure measurement divided by the
fixed location pressure measurement), in some instances. In some
instances, the pressure differential is calculated for each
heartbeat cycle of the patient. In that regard, the calculated
pressure differential is the average pressure differential across a
heartbeat cycle in some embodiments. For example, in some instances
where a hyperemic agent is applied to the patient, the average
pressure differential across the heartbeat cycle is utilized to
calculate the pressure differential. In other embodiments, only a
portion of the heartbeat cycle is utilized to calculate the
pressure differential. The pressure differential is an average over
the portion or diagnostic window of the heartbeat cycle, in some
instances.
[0061] In some embodiments a diagnostic window is selected using
one or more of the techniques described in U.S. patent application
Ser. No. 13/460,296, filed Apr. 30, 2012 and titled "DEVICES,
SYSTEMS, AND METHODS FOR ASSESSING A VESSEL," which is hereby
incorporated by reference in its entirety. As discussed therein,
the diagnostic windows and associated techniques are particularly
suitable for use without application of a hyperemic agent to the
patient. In general, the diagnostic window for evaluating
differential pressure across a stenosis without the use of a
hyperemic agent is identified based on characteristics and/or
components of one or more of proximal pressure measurements, distal
pressure measurements, proximal velocity measurements, distal
velocity measurements, ECG waveforms, and/or other identifiable
and/or measurable aspects of vessel performance. In that regard,
various signal processing and/or computational techniques can be
applied to the characteristics and/or components of one or more of
proximal pressure measurements, distal pressure measurements,
proximal velocity measurements, distal velocity measurements, ECG
waveforms, and/or other identifiable and/or measurable aspects of
vessel performance to identify a suitable diagnostic window.
[0062] Referring now to FIGS. 6-8, the processing system can
generate a screen display including the pressure measurements
and/or pressure ratios at their associated locations based on the
data obtained during blocks 510 and 520. For example, FIG. 6
illustrates a screen display 700 (or partial screen display)
including a visual representation of a vessel. The screen display
includes a visual representation of a vessel 702 into which an
intravascular device having a pressure sensing component is guided.
Angiographic and pressure data can be collected with the
intravascular device within the vessel 702. For example, the
pressure data can be collected during a pullback procedure, which
in the embodiment of FIG. 6 is from the right to the left of the
vessel 702. The collected angiography data can be used to generate
an angiographic image including the vessel 702 and other branch
vessels 704. The one or more visualizations described herein can be
a graphical overlay on the angiographic image. The screen display
700 includes label fields 706 identifying the particular vessel(s).
In some embodiments, a computing device (e.g., computing device 172
of FIG. 4) uses the angiography data, such as the contours,
location, branches, and other features of the vessel(s) to
automatically identify the vessel. The position and/or viewing
angle of the external imaging system (e.g., angiography or x-ray
system) can also be used to identify the vessel. A computing device
can generate the display data associated with the labels 706,
including alphabetical, numerical, alphanumeric, and/or symbolic
characters. In the embodiment of FIG. 7, the labels 706 include an
abbreviation of the identified vessel, such as "RCA" for right
coronary artery and "PLA" for postero-lateral artery. While
abbreviations and particular vessels are used in FIG. 7, it is
understood that any suitable label can be used. In some
embodiments, a user can selectively activate or deactivate one or
more of the labels 706 such that a portion, all, or none of the
labels 706 are included in the screen display 700.
[0063] The screen display 700 also includes markers 708 indicative
of a location within the vessel 702 associated with the collected
pressure measurements or computed pressure ratio. For example, the
markers 708 can be a location of the pressure sensor when the
pressure measurements are collected. In the embodiment of FIG. 6,
the markers 708 are line segments that transect the vessel 702.
Other examples of markers indicative of location are described in
U.S. Provisional Application No. 61/895,909, titled "Devices,
Systems, and Methods for Vessel Assessment," and filed Oct. 25,
2013, the entirety of which is hereby incorporated by reference
herein. In one embodiment, such as during an iFR procedure, one
pressure ratio is computed per heartbeat cycle. Thus, each marker
708 is indicative of collected data and/or computed pressure ratio
during the heartbeat cycle. In some embodiments, a user can
selectively activate or deactivate one or more of the markers 708
such that a portion, all, or none of the markers 708 are included
in the screen display 700. The markers 708 can be separated by
varying distances within the vessel 702, as indicated by distances
710 and 712. In turn, the distances 710 and 712 can correspond to
the speed through which the pressure sensing device is guided
through the vessel 702. In embodiments in which the pressure
sensing device is guided through the vessel 702 at a constant
speed, the distance between the markers 708 is equal or nearly
equal such that successive markers 708 are positioned at equal or
nearly equal intervals. In the embodiments in which the pressure
sensing device is guided through the vessel 702 at a non-constant
speed, the distance between the markers 708 will vary to a greater
extent such that successive markers 708 are positioned at unequal
intervals. For example, the pressure sensing device can be slowed
down near an obstruction such that data from a relatively greater
number of heartbeat cycles is collected. As illustrated in FIG. 6,
there is less distance between successive markers 708 around a
pressure change attributable to an obstruction in the vessel 702.
Co-registration can be implemented such that the location of the
pressure sensing intravascular device within the vessel 702 is
known during each heartbeat cycle. As a result, the pressure
sensing intravascular device can be guided through the vessel 702
(e.g., during a pullback procedure) with a non-constant speed such
that the pace of data collection in the vessel 702 can be
controlled by the clinician. For example, the clinician can slow
down for more information near a clinically significant portion of
the vessel 702 such as a lesion. For example, the clinician can
speed up through non-clinically significant portions of the vessel
702.
[0064] The pressure change in the vessel 702 is indicated by the
pressure ratio fields 714. The pressure ratio fields are provided
adjacent the markers 708. In the embodiment of FIG. 6, only a
portion of the pressure ratio fields 714 are shown. In various
embodiments, a portion, all, or none of the pressure ratio fields
714 can provide the computed pressure ratio associated with a given
location. For example, a user can selectively activate or
deactivate one or more of the pressure ratio fields 714. In various
embodiments, the pressure ratio fields 714 include alphabetical,
numerical, alphanumeric, and/or symbolic characters. In FIG. 6, the
fields 714 include are numeric values associated with an iFR
calculation. In other embodiments, the fields 714 can include an
FFR, iFR, Pd/Pa, compensated Pd/Pa, or other label to identify the
type of quantity being displayed. Such embodiments are described,
for example, in U.S. Provisional Application No. 61/895,909, titled
"Devices, Systems, and Methods for Vessel Assessment," and filed
Oct. 25, 2013, the entirety of which is hereby incorporated by
reference herein. A pressure change is indicated by the values in
the fields 714. For example, in FIG. 6, an obstruction in the
vessel 702 likely exists between the values 0.93 and 0.81.
[0065] FIGS. 7 and 8 illustrate screen displays 800 and 850 (or
partial screen displays) including a visual representation of a
pressure ratio. The data depicted in the screen displays 800 and
850 of FIGS. 7 and 8, respectively, correspond to the data shown in
screen display 700 of FIG. 6. The screen displays 800 and 850
include curves 802, 852 respectively of the pressure ratios within
the vessel 702. The curves 802, 852 are representative of the same
data, except that the x-axes are different. The screen display 800
(FIG. 7) includes time or distance on the x-axis and a pressure
ratio quantity (such as iFR, FFR, Pd/Pa, etc.) on the y-axis. For
example, in the embodiment shown in FIG. 6, a moving pressure
sensing device can be guided from right to left within the vessel
702 during the pullback procedure while a fixed pressure sensing
device remains stationary on the left side or proximal portion of
the vessel 702. Values along the x-axis of screen display 800 can
correspond to the duration of a pullback procedure and/or distance
traveled by the moving pressure sensing device during the pullback
procedure. The screen display 850 includes position corresponding
to the physical orientation of the vessel 702 along the x-axis and
a pressure ratio quantity (such as iFR, FFR, Pd/Pa, etc.) on the
y-axis. That is, the screen display 850 shows the pressure ratios
associated with the left side of the vessel 702 on the left side of
the curve 852 and the pressure ratios associated with the right
side of the vessel 702 on the right side of the curve 852. In some
instances, providing a pressure ratio plot that corresponds to the
physical location along the vessel can facilitate easier PCI
planning for a user. The discussion below generally refers to the
screen display 850, but it is understood that the screen display
800 can be equivalently utilized.
[0066] The screen displays 800 and 850 include an ideal pressure
ratio line 806. The ideal line 806 is representative of a pressure
ratio equal to one (1), which is indicative of a vessel with no
obstructions. Physiologically, a pressure ratio equal to one (1) is
the maximum possible pressure ratio and occurs when proximal and
distal pressure measurements are equal. During PCI planning, a
clinician tries to determine treatment parameters that will cause a
patient's pressure ratios to return as closely as possible to the
ideal line 806.
[0067] The screen displays 800 and 850 include a threshold pressure
ratio 804. The threshold 804 can be set at a value indicative of
transition between pressure ratios representative of a healthy
vessel and pressure ratios representative of a vessel having a
significant obstruction. Pressure ratios above the threshold 804
can be representative of a vessel for which treatment is not
recommended, and pressure ratios below the threshold 804 can be
representative of a vessel for which treatment is recommended. The
threshold 804 can vary depending on the pressure ratio scale (e.g.,
iFR, FFR, Pd/Pa, etc.) used in the screen displays 800 and 850. For
example, the threshold 804 for FFR can be 0.80, and the threshold
804 for iFR can be 0.89. For example, if a vessel has FFR values
above 0.80, the clinician can determine not to treat the vessel. If
the vessel has FFR values below 0.80, the clinician can determine
to treat the vessel with a PCI. In some instances the threshold
values are set empirically. In other instances, the threshold
values are set, at least partially, based on user
preference/selection.
[0068] The screen displays 800 and 850 include a target line 820.
The target line 820 can correspond to a pressure ratio value that
is associated with clinically beneficial outcomes for the patient.
The target line 820 can correspond to a pressure ratio value higher
than the threshold 804 in some embodiments. That is, the threshold
804 can represent a minimum pressure ratio value that can be
considered healthy, while the target line 820 can represent a
higher pressure ratio value that is associated with efficacious
treatment. The target line 820 can vary depending on the pressure
ratio scale (e.g., iFR, FFR, Pd/Pa, etc.) used in the screen
displays 800 and 850. For example, the target line 820 for FFR can
be 0.93. The graphical user interface for PCI planning can allow
the clinician to set the pressure ratio value for the threshold 804
and/or the target line 820. For example, the clinician can access
settings options that allow for modification of the threshold 804
and/or the target line 820. It is desirable to return the actual
pressure ratio values of the curves 802 and 852 to the value
indicated by the ideal line 806. However, it may not be medically
possible to recreate perfect flow within a stenosed vessel for a
variety of reasons. In such circumstances, the target line 820
represents a medically acceptable pressure ratio values that are
indicative of efficacious treatment. In some instances, the target
line 820 is a desired outcome set by the user from which the system
identifies available treatment options for achieving the pressure
ratio values satisfying the target line 820. Thus, during PCI
planning, the system can determine treatment parameters to return
the patient's pressure ratio values to as close to the ideal line
806 as possible and at least above the target line 820. The
threshold 804, the target line 820, and/or the ideal line 806 can
be selectively provided on the screen displays 800 and 850, in
response to a user input to show/hide the visualizations. In that
regard, it is understood that none or any one or more the threshold
804, the target line 820, and/or the ideal line 806 can be provided
on the screen displays.
[0069] In some embodiments, various colors and/or other visual
indicators are provided on the screen displays 800 and 850 to
indicate a difference between the threshold 804 and the actual
pressure ratio. For example, a first color (e.g., green, white, or
otherwise) can be utilized to represent values well above the
threshold value (e.g., where the threshold value is 0.80 on a scale
of 0.00 to 1.00, values above 0.90), a second color (e.g., yellow,
gray, or otherwise) can be utilized to represent values near but
above the threshold value (e.g., where the threshold value is 0.80
on a scale of 0.00 to 1.00, values between 0.81 and 0.90), and a
third color (e.g., red, black, or otherwise) can be utilized to
represent values equal to or below the threshold value (e.g., where
the threshold value is 0.80 on a scale of 0.00 to 1.00, values of
0.80 and below). It is appreciated that any number of color
combinations, scalings, categories, and/or other characteristics
can be utilized to visually represent the relative value of the
pressure differential to the threshold value. However, for the sake
of brevity Applicants will not explicitly describe the numerous
variations herein.
[0070] The screen displays 800 and 850 additionally include markers
808 and pressure ratio fields 814. The markers 808 and pressure
ratio fields 814 are similar to those described in the context of
FIG. 6. While the curves 802 and 852 are depicted as continuous in
FIGS. 7 and 8, the markers 808 can be representative of actual data
points on the curves 802 and 852. The values of the curves 802 and
852 between the markers 808 can be interpolated based on the
pressure ratios associated with the markers 808. A computing device
(e.g., computing device 172 of FIG. 4) can provide data processing,
data interpolation, smoothing, and perform other computations to
generate the pressure ratio curves 802 and 852. The ideal pressure
ratio line 806, the threshold 804, markers 808, and pressure ratio
fields 814 can be selectively activated and deactivated such that a
portion, all, or none appear the screen displays 800 and 850.
[0071] At block 530, the method 500 includes receiving a user input
(or multiple user inputs) regarding a desired outcome. In this
regard, the desired outcome can be a desired and/or minimum
pressure ratio (e.g., iFR, FFR, Pd/Pa, etc.) at one or more
positions along the length of the vessel. For example, in some
instances a user may input an overall desired pressure ratio for
the vessel (e.g., iFR.gtoreq.0.93). Further, in some instances a
user may input a desired pressure ratio for multiple locations
along the length of a vessel (e.g., location 1: iFR.gtoreq.0.96,
location 2: iFR.gtoreq.0.95, location 3: iFR.gtoreq.0.93, etc.). To
this end, a user interface may display the vessel and/or a
graphical representation of the pressure measurements/ratios to
allow a user to visualize the locations of the desired outcome(s)
relative to the current state of the vessel. Further, the user
interface can include buttons, input fields, toggles, sliders,
and/or other interface mechanisms to allow the user to input the
desired outcome (e.g., target and/or minimum pressure ratios)
and/or the respective location(s) for the desired outcome. Also,
the user interface may allow the user to select what treatment
options should be considered for a patient. For example, in some
instances the user may select one or more of stenting, angioplasty,
bypass, ablation, pharmaceutical, other treatment options, and/or
combinations thereof. For example, each of FIGS. 9-12 illustrates
an exemplary approach where a user input box 880 is provided in the
upper right hand corner of each display. As shown, the illustrated
user input box 880 allows a user to specify a desired iFR/FFR
value, specify a minimum iFR/FFR value, and select the available
treatment options for consideration by the system for treatment
planning purposes.
[0072] Referring again to FIG. 5, at block 540, the method 500
includes conducting treatment planning to identify one or more
suitable treatment options for achieving the desired outcome of
block 530. For example, the treatment planning can include
determining which of the available treatment options is best suited
to achieve the desired outcome. The processing system can make this
determination by utilizing empirical data of the treatment of
previous patients with similar symptoms and treatment(s), expected
effect of treatment (e.g., as stated by the manufacturer/supplier
of the treatment, as defined by the user, as established by
empirical treatment data, and/or combinations thereof), and/or
combinations thereof. In some embodiments, the treatment planning
includes having a computing device (e.g., computing device 172) of
the system determine one or more recommended characteristics of a
stent, angioplasty balloon, ablation area, and/or other treatment
option to be deployed within the vessel 702. For example, for a
stent deployment, the computing device may determine
suitable/desired position, diameter, length, material, etc. for one
or more stent locations. For angioplasty, the computing device may
determine suitable/desired position(s), balloon size (length,
inflated diameter), balloon material, etc. for one or more
angioplasty locations. For ablation, the computing device may
determine suitable/desired ablation type (e.g., laser, ultrasound,
cryo, etc.), position(s), amount of material to be removed, etc.
for one or more ablation locations. The determination of the one or
more characteristics of the different treatment types can be based
on the collected pressure data, computed pressure ratio(s),
angiography data, a threshold pressure ratio, a target pressure
ratio, an ideal pressure ratio, etc. For example, the
characteristics of the treatment(s) can be selected to remedy a
drop in the pressure ratio across an obstruction. The computing
device can determine the suitable/desired characteristics of the
treatment option(s) and identify the available and/or recommended
treatment option(s).
[0073] At block 550, the method 500 includes outputting a screen
display that includes a visual representation of the one or more
suitable treatments identified during the treatment planning at
block 540. For example, as shown in FIGS. 9-12, the screen display
can include visualizations based on the pressure measurements
and/or a visual representation of the vessel along with the
recommended treatment option(s). In some embodiments, the visual
representation of the vessel is a two-dimensional or
three-dimensional angiographic image of the vessel, such as an
angiographic image generated based on angiography data collected at
block 520. In some embodiments, visual representation of the vessel
is two-dimensional or three-dimensional graphical representation of
the vessel, such as a stylized image or reconstruction of the
vessel. The visualization based on the pressure measurements can
include numerical, graphical, textual, and/or other suitable
visualizations based on the pressure data collected at block 510.
Collectively, the visualizations can include one or more of
treatment overlaid onto the visual representation of the vessel,
calculated pressure ratio(s), markers indicative of a location
within the vessel of the obtained pressure measurements or the
calculated pressure ratio(s), a label identifying the vessel, among
others. In some embodiments, the visualization based on the
pressure measurements can include a heat map in which the visual
representation of the vessel is colorized or otherwise gradated to
shows changes in the obtained pressure measurements or calculated
pressure ratio(s). Examples of screen displays including a heat
map, calculated pressure ratios, markers indicative of a location
associated with the obtained pressure measurements or the
calculated pressure ratios, and other visualizations are described
in U.S. Provisional Application No. 61/895,909, titled "Devices,
Systems, and Methods for Vessel Assessment," and filed Oct. 25,
2013, the entirety of which is hereby incorporated by reference
herein. In various embodiments, other collected data, computed
quantities, etc., such as ECG waveforms, numerical values, can be
provided on the screen display as described in U.S. Provisional
Application No. 62/049,265, titled "Bedside Controller for
Assessment of Vessels and Associated Devices, Systems, and
Methods," and filed Sep. 11, 2014, the entirety of which is hereby
incorporated by reference herein.
[0074] Referring more specifically to FIGS. 9 and 10, shown therein
are examples of screen displays illustrating a treatment option
identified in block 540. In this regard, the data and treatment
option depicted in the screen display 900 (FIG. 9) corresponds to
the data shown in screen display 1000 (FIG. 10). In particular, a
graphical representation of a stent 902 is positioned in the visual
representation of the vessel 702. For clarity purposes, the
following discussion focuses on a stent treatment. However, it is
understood that the same concepts apply to other treatment options
including, angioplasty, ablation, bypass, etc. The stent 902 can be
inserted into or overlaid onto the image of the vessel in response
to system identifying the stent 902 as the best treatment option
based on the analysis at block 540. As described above, the
location, length, diameter, material, and/or other characteristics
of the stent 902 can be automatically determined by a computing
device and corresponding displayed on the screen display 900 at the
location of deployment. For example, the diameter of the stent can
be auto-sized to match the diameter of the vessel in the
angiographic image. The image characteristics of the stent 902 that
determine how the stent 902 appears in the screen display 900 can
be chosen such that the stent 902 is visually distinguishable
within the vessel 702. The image characteristics can include a
color, shading, pattern, transparency, borders, and other related
characteristics. In some embodiments, the image characteristics of
the stent 902 are selected to match the physical appearance of an
actual stent. In some embodiments, the image characteristics of the
stent 902 are selected to highlight a region within the vessel 702
in which the stent is inserted. Further, estimated physiologic
values (e.g., iFR, FFR, Pd/Pa, etc.) associated with deployment of
the stent within the vessel 702 can be determined by the system
based on the location, length, diameter, material, and/or other
virtual/simulated characteristics of the stent 902. The estimated
physiologic values can be displayed on the screen display to show
the physiologic change caused by deployment of the stent (or other
treatment). For example, in some instances FIG. 9 can be considered
an updated version of FIG. 6 showing the position of the stent 902
within the vessel and the estimated pressure ratio values
associated with the treatment. In some instances, the original
pressure ratio values may be displayed alongside the estimated
pressure ratio values so that a user can see the estimated effects
of the treatment.
[0075] FIG. 10 illustrates a screen display 1000 (or partial screen
display) including a visual representation of a pressure ratio. The
data depicted in the screen display 1000 (FIG. 10) corresponds to
the data shown in screen display 900 (FIG. 9). A graphical
representation of the stent 902 is positioned along the visual
representation of the pressure ratio curve 852. The characteristics
of the graphical representation of stent 902, such as the position
and length, among others, correspond to the characteristics of the
graphical representation of stent 902 that is positioned within the
vessel 702 (FIG. 9). The screen display 1000 (FIG. 10) includes
corrected pressure curve 1004. The corrected pressure curve 1004
represents the anticipated changes to pressure curve 852 as a
result of the deployment of the stent 902. No change in the
pressure is expected across the length of the stent 902, as
illustrated in the corrected pressure curve 1004. That is,
placement of the stent 902 is ideally creating perfect or near
perfect flow across that portion of the vessel 702. An end of the
stent 902 can be indicated by a stent end notation 1006. In
different embodiments, various other graphical representations of
the stent end can be utilized. The stent end notation 1006 can be
selectively provided to the screen display 1000, e.g., based on a
user input to show/hide the visualization. The stent end notation
1006 is representative of the point beyond which the corrected
pressure curve 1004 is expected to behave like the pressure curve
852. As shown, the corrected pressure curve 1004 is shaped similar
to the pressure curve 852, past the stent end notation 1006.
However, the pressure values indicated by the corrected pressure
curve 1004 are higher as a result of the stent 902 correcting at
least a portion of the pressure drop across a lesion in the vessel.
Similar display approaches can be used to visualize the effects of
other treatment options identified at block 540, including
angioplasty, ablation, bypass, etc.
[0076] Screen display 1000 additionally includes a corrected
pressure ratio value 1010. The corrected pressure ratio value 1010
can correspond to the numerical value of the corrected pressure
ratio curve 1004. One or both of the corrected pressure ratio value
1010 and the corrected pressure ratio curve 1004 can provide a
clinician validation that the selected treatment will achieve the
target and/or minimum pressure ratio values set by the user as the
desired outcome for the patient. For example, the threshold 804 can
correspond to an iFR value of 0.89, above which vessels can be
characterized as healthy. If the corrected pressure ratio value
1010 provides an iFR value that is greater than 0.89 (as it does in
the embodiment of FIG. 10), the clinician can understand that the
placement of the stent with the given parameters (e.g., length,
diameter, position, etc.) will provide some benefit in treating the
vessel. The corrected pressure ratio value 1010 can be associated
with the distal portion of the corrected pressure ratio curve 1004
(e.g., the distal most value, an average of values of the corrected
pressure ratio curve, etc.). The corrected pressure ratio value
1010 can be provided adjacent corrected pressure ratio curve 1004.
The corrected pressure ratio value 1010 can be selectively provided
in response to a user input to show/hide the visualization.
[0077] A computing device (e.g., computing device 172) can compute
the values of the corrected pressure curve 1004 based on the
obtained pressure measurements, calculated pressure ratios, target
pressure ratio, ideal pressure ratio, etc. The corrected pressure
curve 1004 can be computed and provided to the user such that the
curve 1004 is adjusted based on the treatment(s) identified in
block 540. In this regard, the system can modify the
characteristics of the treatment(s) so that the values of the
corrected pressure curve are as close to being equal to an ideal
pressure ratio (such the ideal pressure ratio line 806 of FIG. 8)
and/or at least greater than a target pressure ratio (such as the
target line 820 of FIG. 8).
[0078] FIGS. 11 and 12 are similar in many respects to FIGS. 9 and
10, but each show two identified treatment options and the
corresponding effects to the pressure ratios. For example, FIGS. 11
and 12 each show a first treatment option (stent 902) and a second
treatment option (1102) and the corresponding estimated effects to
the pressure ratio. As shown, each of the treatment options (stents
902 and 1102) satisfy the threshold line 804, but only the second
treatment option (stent 1102) satisfies the target line 820.
However, there may be situations where the second treatment option
(stent 1102) is not available and/or advisable for one reason or
another (e.g., the stent 1102 is not in inventory, stent 1102 is
not advisable due to another patient characteristic, etc.) such
that the first treatment option (stent 902) is the best available
treatment option.
[0079] At block 560, a treatment option is selected for
implementation from the one or more suitable treatments identified
during the treatment planning. In this regard, a user can select
the best available treatment from the identified treatment options
based on the visualizations of the treatment options (e.g., as
shown in FIGS. 9-12), user experience, and/or other factors.
Further, in some instances, at block 560 the method 500 includes
receiving a user input to modify one or more features of the
treatment option(s) identified by the system at block 540 to select
a treatment option for implementation. The user input can be to
insert a stent into the visual representation of the vessel and/or
move the stent within the vessel. The user input can be to change
one or more characteristics of the stent, such as length, diameter,
material, etc. For example, the user input can be to increase or
decrease the length of the stent within the vessel. The user input
can be received at a user interface device. In some embodiments,
the user input is a touch input received at a touch sensitive
display of a bedside controller. The screen display can be updated
to reflect the changes to the treatment option(s) based on the user
input. For example, in response to the user input, a stent can be
inserted into the visual representation of the vessel, the location
of the stent within the vessel can be changed, and one or more
characteristics of the stent (e.g., length, diameter, material,
etc.) can be changed. The estimated pressure ratio values can also
be updated based on the changes to the proposed treatment
options.
[0080] In some instances, the clinician can decide that none of the
identified treatment options are suitable for implementation. For
example, even the best treatment option(s) identified by the system
do not result in the corrected pressure ratio curve 1004 or the
corrected pressure ratio value 1004 equaling or exceeding the
target line 820, at which clinical benefits are likely to result
from the therapeutic intervention. In such instances, no treatment
option is selected at block 560 and the method 500 can return to
block 530, as indicated by line 565. At block 530, the clinician
can then vary the desired outcome(s) and/or available treatment
options for the system to select from to broaden the available
treatment options in an effort to identify an suitable treatment
option. The method can then proceed to block 540 and continue until
a suitable treatment option is identified.
[0081] At block 570, the method 500 includes performing the
treatment option selected at block 560.
[0082] At block 580, the method 500 includes verifying the desired
outcome has been achieved by performing the selected treatment
option. For example, where the desired outcome was achieving a
minimum pressure ratio, pressure measurements can be obtained after
performing the selected treatment to determine whether the minimum
pressure ratio has been achieved. If minimum pressure ratio has
been achieved, then the treatment is considered successful and the
clinician can conclude the treatment. If the minimum pressure ratio
has not been achieved, then the clinician can verify that the
treatment was performed properly (e.g., confirm that the stent is
fully deployed) and/or evaluate what steps should be taken next,
which can include additional diagnosis/treatment or concluding the
treatment with the current results. In some instances, the method
500 is repeated to identify a further treatment option if the
desired outcome has not been achieved with the treatment option
performed at block 570.
[0083] Persons skilled in the art will also recognize that the
apparatus, systems, and methods described above can be modified in
various ways. Accordingly, persons of ordinary skill in the art
will appreciate that the embodiments encompassed by the present
disclosure are not limited to the particular exemplary embodiments
described above. In that regard, although illustrative embodiments
have been shown and described, a wide range of modification,
change, and substitution is contemplated in the foregoing
disclosure. It is understood that such variations may be made to
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 present
disclosure.
* * * * *