U.S. patent application number 14/774211 was filed with the patent office on 2016-01-28 for interface devices, systems, and methods for use with intravascular pressure monitoring devices.
The applicant listed for this patent is VOLCANO CORPORATION. Invention is credited to Dale Dorando.
Application Number | 20160022153 14/774211 |
Document ID | / |
Family ID | 51530525 |
Filed Date | 2016-01-28 |
United States Patent
Application |
20160022153 |
Kind Code |
A1 |
Dorando; Dale |
January 28, 2016 |
Interface Devices, Systems, And Methods For Use With Intravascular
Pressure Monitoring Devices
Abstract
Embodiments of the present disclosure are configured to assess
the severity of a blockage in a vessel and, in particular, a
stenosis in a blood vessel. In some particular embodiments, the
devices, systems, and methods of the present disclosure are
configured to provide FFR measurements over a length of a vessel of
interest in a small, compact device that integrates with existing
proximal and distal pressure measurement systems and does not
require a separate power source.
Inventors: |
Dorando; Dale; (Shingle
Springs, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
VOLCANO CORPORATION |
San Diego |
CA |
US |
|
|
Family ID: |
51530525 |
Appl. No.: |
14/774211 |
Filed: |
March 13, 2014 |
PCT Filed: |
March 13, 2014 |
PCT NO: |
PCT/US14/26521 |
371 Date: |
September 10, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61790755 |
Mar 15, 2013 |
|
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Current U.S.
Class: |
600/486 |
Current CPC
Class: |
A61B 2562/0247 20130101;
A61B 5/02007 20130101; A61B 5/0215 20130101; A61B 5/02158 20130101;
A61B 5/026 20130101; A61B 5/743 20130101; A61B 5/6851 20130101;
A61B 5/6852 20130101; A61B 5/742 20130101 |
International
Class: |
A61B 5/02 20060101
A61B005/02; A61B 5/0215 20060101 A61B005/0215; A61B 5/00 20060101
A61B005/00 |
Claims
1. An interface for intravascular pressure sensing devices,
comprising: a distal input configured to receive a distal pressure
signal from a distal pressure sensing device; a proximal input
configured to receive a proximal pressure signal from a proximal
pressure sensing device; a pullback device configured to interface
with a proximal portion of the distal pressure sensing device to
cause translation of the distal pressure sensing device relative to
the proximal pressure sensing device; a processor in communication
with the distal input, proximal input, and the pullback device, the
processor configured to calculate a pressure differential between
the distal pressure and the proximal pressure based on the received
distal pressure signal and the received proximal pressure signal
obtained as the pullback device translates the distal pressure
sensing device relative to the proximal pressure sensing device;
and a display in communication with the processor and configured to
display the pressure differential calculated by the processor
including a relative position of the distal pressure sensing device
to the proximal pressure sensing device associated with the
calculated pressure differential.
2. The interface of claim 1, further comprising: a distal output
configured to output the distal pressure signal to a hemodynamic
system in a format useable by the hemodynamic system; a proximal
output configured to output the proximal pressure signal to the
hemodynamic system in a format useable by the hemodynamic
system;
3. The interface of claim 2, wherein the distal input, distal
output, proximal input, proximal output, and processor are secured
to a housing.
4. The interface of claim 3, wherein the housing has a width
between 5 cm and 25 cm, a height between 5 cm and 25 cm, and a
depth between 1 cm and 10 cm.
5. The interface of claim 1, herein the distal pressure sensing
device is a pressure-sensing guide wire.
6. The interface of claim 5, wherein the proximal pressure sensing
device is a pressure-sensing catheter.
7. The interface of claim 1, wherein the processor is further
configured to identify a diagnostic window for calculating the
pressure differential, the diagnostic window consisting of a
portion of a heartbeat cycle of a patient.
8. The system of claim 7, wherein the portion of the heartbeat
cycle of the patient is selected at least partially based on one or
more characteristics of the proximal pressure signal.
9. The system of claim 7, wherein the portion of the heartbeat
cycle of the patient is selected at least partially based on one or
more characteristics of the distal pressure signal.
10. A system for evaluating a vascular stenosis, the system
comprising: a distal pressure sensing device sized and shaped for
insertion into human vasculature; a proximal pressure sensing
device sized and shaped for insertion into human vasculature; and
an interface comprising: a distal input configured to receive a
distal pressure signal from a distal pressure sensing device; a
proximal input configured to receive a proximal pressure signal
from a proximal pressure sensing device; a pullback device
configured to interface with a proximal portion of the distal
pressure sensing device to cause translation of the distal pressure
sensing device relative to the proximal pressure sensing device; a
processor in communication with the distal input, proximal input,
and the pullback device, the processor configured to calculate a
pressure differential between the distal pressure and the proximal
pressure based on the received distal pressure signal and the
received proximal pressure signal obtained as the pullback device
translates the distal pressure sensing device relative to the
proximal pressure sensing device; and a display in communication
with the processor of the interface, the display configured to
display the pressure differential calculated by the processor
including a relative position of the distal pressure sensing device
to the proximal pressure sensing device associated with the
calculated pressure differential.
11. The system of claim 10, wherein the display is a
touchscreen.
12. The system of claim 10, wherein the display is further
configured to display the proximal pressure and the distal
pressure.
13. The system of claim 10, wherein the interface further comprises
a distal output configured to output the distal pressure signal to
a processing system in a format useable by the processing
system.
14. The system of claim 13, wherein the processing system is a
hemodynamic system.
15. The system of claim 13, wherein the distal input, distal
output, proximal input, and processor are secured to a housing.
16. The system claim 10, wherein the distal pressure sensing device
is a pressure-sensing guide wire.
17. The system of claim 16, wherein the proximal pressure sensing
device is a pressure-sensing catheter.
18. The system of claim 10, wherein the processor is farther
configured to identify a diagnostic window for calculating the
pressure differential, the diagnostic window consisting of a
portion of a heartbeat cycle of a patient.
19. The system of claim 18, wherein the portion of the heartbeat
cycle of the patient is selected at least partially based on one or
more characteristics of the proximal pressure signal.
20. The system of claim 18, wherein the portion of the heartbeat
cycle of the patient is selected at least partially based on one or
more characteristics of the distal pressure signal.
Description
TECHNICAL FIELD
[0001] The present disclosure relates generally to the assessment
of vessels and, in particular, the assessment of the severity of a
blockage or other restriction to the flow of fluid through a
vessel. Aspects of the present disclosure are particularly suited
for evaluation of biological vessels in some instances. For
example, some particular embodiments of the present disclosure are
specifically configured for the evaluation of a stenosis of a human
blood vessel.
BACKGROUND
[0002] A currently accepted technique for assessing the severity of
a stenosis in a 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. Common treatment options include angioplasty
and stenting.
[0003] Coronary blood flow is unique in that it is affected not
only by fluctuations in the pressure arising proximally (as in the
aorta) but is also simultaneously affected by fluctuations arising
distally in the microcirculation. Accordingly, it is not possible
to accurately assess the severity of a coronary stenosis by simply
measuring the fall in mean or peak pressure across the stenosis
because the distal coronary pressure is not purely a residual of
the pressure transmitted from the aortic end of the vessel. As a
result, for an effective calculation of FFR within the coronary
arteries, it is necessary to reduce the vascular resistance within
the vessel. Currently, pharmacological hyperemic agents, such as
adenosine, are administered to reduce and stabilize the resistance
within the corollary arteries. These potent vasodilator agents
reduce the dramatic fluctuation in resistance (predominantly by
reducing the microcirculation resistance associated with the
systolic portion of the heart cycle) to obtain a relatively stable
and minimal resistance value.
[0004] However, the administration of hyperemic agents is not
always possible or advisable. First, the clinical effort of
administering hyperemic agents can be significant. In some
countries (particularly the United States), hyperemic agents such
as adenosine are expensive, and time consuming to obtain when
delivered intravenously (IV). In that regard, IV-delivered
adenosine is generally mixed on a case-by-case basis in the
hospital pharmacy. It can take a significant amount of time and
effort to get the adenosine prepared and delivered to the operating
area. These logistic hurdles can impact a physician's decision to
use FFR. Second, some patients have contraindications to the use of
hyperemic agents such as asthma, severe COPD, hypotension,
bradycardia, low cardiac ejection fraction, recent myocardial
infarction, and/or other factors that prevent the administration of
hyperemic agents. Third, many patients find the administration of
hyperemic agents to be uncomfortable, which is only compounded by
the fact that the hyperemic agent may need to be applied multiple
times during the course of a procedure to obtain FFR measurements.
Fourth, the administration of a hyperemic agent may also require
central venous access (e.g., a central venous sheath) that might
otherwise be avoided. Finally, not all patients respond as expected
to hyperemic agents and, in some instances, it is difficult to
identify these patients before administration of the hyperemic
agent.
[0005] To obtain FFR measurements, one or more ultra-miniature
sensors placed on the distal portion of a flexible device, such as
a catheter or guide wire used for catheterization procedures, are
utilized to obtain the distal pressure measurement, while a sensor
connected to a measurement instrument, often called the hemodynamic
system, is utilized to obtain the proximal or aortic pressure
measurement. Currently only large expensive systems or a
combination of multiple devices connected to the distal pressure
wire and the hemodynamic system can calculate and display an FFR
measurement. In that regard, to calculate the FFR these devices
require both the aortic or proximal pressure measurement and the
coronary artery or distal pressure measurement. Accordingly, these
systems require the catheter lab's hemodynamic system to have a
high level analog voltage output. "High level" in this context
generally implies 100 mmHg/Volt output. Unfortunately, there are
many hemodynamic systems that don't provide a high level output. As
a result, when using these hemodynamic systems, providing an FFR
measurement is difficult if not impossible. Further, space in a
typical catheter lab is extremely limited. Consequently, devices
that are large and located in the catheter lab are disfavored
compared to smaller derives, especially if the smaller device can
provide much if not all of the functionality of the larger device.
As a result, it is highly desirable to have a device that that can
display FFR and yet is small and lightweight that can sit on, or
near, the patient bed and be easily read by the physician.
[0006] Further, most pressure measurement devices require an extra
source of power like an AC adapter or wall plug. This adds to wire
clutter and available medical grade AC outlets are not often
available near the patient bed. In addition, any device that uses
AC power must undergo stringent safety precautions to reduce
patient risk due to leakage currents. Batteries are another
alternative for power. But, batteries must be replaced, disposed of
correctly and have a finite shelf life.
[0007] Further still, FFR measurements are traditionally made with
the proximal and distal pressure sensing devices maintained at
static locations (e.g., within the aorta and distal of a suspected
stenosis, in some instances) when the hyperemic agent is applied.
Accordingly, the resulting FFR measurements provide data in the
context of those static positions.
[0008] 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. In that
regard, there remains a need for improved devices, systems, and
methods for providing FFR measurements that have a small, compact
size (e.g., suitable for hand-held use), integrate with existing
proximal and distal pressure measurement devices, and provide FFR
measurements over a length of a vessel of interest rather than at a
single, static location.
SUMMARY
[0009] Embodiments of the present disclosure are configured to
assess the severity of a blockage in a vessel and, in particular, a
stenosis in a blood vessel. In sonic particular embodiments, the
devices, systems, and methods of the present disclosure are
configured to provide FFR measurements in a small, compact device
that integrates with existing proximal and distal pressure
measurement systems and provide FFR measurements over a length of a
vessel of interest rather than at a single point.
[0010] In one embodiment, an interface for intravascular pressure
sensing devices is provided. The interface comprises: a distal
input configured to receive a distal pressure signal from a distal
pressure sensing device; a proximal input configured to receive a
proximal pressure signal from a proximal pressure sensing device; a
pullback device configured to interface with a proximal portion of
the distal pressure sensing device to cause translation of the
distal pressure sensing device relative to the proximal pressure
sensing device; a processor coupled to the distal input, proximal
input, and the pullback device, the processor configured to
calculate a pressure differential between the distal pressure and
the proximal pressure based on the received distal pressure signal
and the received proximal pressure signal obtained as the pullback
device translates the distal pressure sensing device relative to
the proximal pressure sensing device; and a display in
communication with the processor and configured to display the
pressure differential calculated by the processor including a
relative position of the distal pressure sensing device to the
proximal pressure sensing device associated with the calculated
pressure differential. In some embodiments, the distal input,
distal output, proximal input, proximal output, and processor are
secured to a housing. Further, in sonic instances the distal
pressure sensing device is a pressure-sensing guide wire and the
proximal pressure sensing device is a pressure-sensing catheter
configured for use with the hemodynamic system.
[0011] In another embodiment, a system for evaluating a vascular
stenosis is provided. The system comprises: a distal pressure
sensing device sized and shaped for insertion into human
vasculature; a proximal pressure sensing device sized and shaped
for insertion into human vasculature; and an interface, where the
interface includes: a distal input configured to receive a distal
pressure signal from a distal pressure sensing device; a proximal
input configured to receive a proximal pressure signal from a
proximal pressure sensing device; a pullback device configured to
interface with a proximal portion of the distal pressure sensing
device to cause translation of the distal pressure sensing device
relative to the proximal pressure sensing device; a processor
coupled to the distal input, proximal input, and the pullback
device, the processor configured to calculate a pressure
differential between the distal pressure and the proximal pressure
based on the received distal pressure signal and the received
proximal pressure signal obtained as the pullback device translates
the distal pressure sensing device relative to the proximal
pressure sensing device; and a display in communication with the
processor and configured to display the pressure differential
calculated by the processor including a relative position of the
distal pressure sensing device to the proximal pressure sensing
device associated with the calculated pressure differential.
[0012] Additional aspects, features, and advantages of the present
disclosure will become apparent from the following detailed
description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] Illustrative embodiments of the present disclosure will be
described with reference to the accompanying drawings, of
which:
[0014] FIG. 1 is a diagrammatic perspective view of a vessel having
a stenosis according to an embodiment of the present
disclosure.
[0015] 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.
[0016] 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.
[0017] FIG. 4 is a diagrammatic, schematic view of a system
according to an embodiment of the present disclosure.
[0018] FIG. 5 is a diagrammatic, schematic view of a system
according to an embodiment of the present disclosure.
[0019] FIG. 6 is a diagrammatic, schematic view of a system
according to an embodiment of the present disclosure.
[0020] FIG. 7 is a diagrammatic, schematic view of an interface
device of the system of FIG. 6 according to an embodiment of the
present disclosure.
[0021] FIG. 8 is a diagrammatic, schematic view of a portion of the
interface device of FIG. 7 according to an embodiment of the
present disclosure.
[0022] FIG. 9 is a diagrammatic, schematic view of a portion of the
interface device of FIG. 7 similar to that of FIG. 8, but
illustrating another embodiment of the present disclosure.
[0023] FIG. 10 is a graphical representation of proximal and distal
pressure measurements over time during a pullback of a pressure
sensing device obtaining the distal pressure measurements according
to an embodiment of the present disclosure.
[0024] FIG. 11 is a graphical representation of proximal and distal
pressure measurements during the pullback of the pressure sensing
device obtaining the distal pressure measurements as shown in FIG.
10, but illustrating the proximal and distal pressure measurements
relative to a distance according to an embodiment of the present
disclosure.
DETAILED DESCRIPTION
[0025] 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.
[0026] 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 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.
[0027] 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.
[0028] 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.
[0029] 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.
[0030] 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 that regard, the single
instrument incorporates aspects of the functionalities (e.g., data
acquisition) of both instruments 130 and 132 in some
embodiments.
[0031] 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), 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.
[0032] 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 PrimeWire
PRESTIGE.RTM. pressure guide wire, the PrimeWire.RTM. 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.
[0033] 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), 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.
[0034] 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 that include pressure monitoring elements
can be utilized for instrument 132 in some instances.
[0035] 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. 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, in some instances, the proximal pressure measurement is
referred to as the aortic pressure.
[0036] As will be discussed below, in some implementations
instrument 130 is moved through the vessel 100 while obtaining
pressure measurements. In that regard, in some implementations the
instrument 130 is initially positioned distal of a region of
interest and then pull backed through and across the region of
interest. To facilitate movement of the instrument 130 through the
vessel, a proximal section of the instrument is coupled to a
pullback device and/or other actuator configured to impart
translational movement to the instrument 130 and, in particular,
the at least one element of the instrument configured to monitor
pressure within the vessel 100. In some implementations, the
pullback device is configured to move at least a portion of the
instrument 130 at a continuous speed for a fixed distance (e.g., 5
cm, 10 cm, 15 cm, or otherwise) and/or time (e.g., 10 seconds, 20
seconds, 30 seconds, 40 seconds, 50 seconds, 60 seconds, or
otherwise). In other implementations, the pullback device is
configured to move at least a portion of the instrument 130 in a
step-wise manner (i.e., move for a certain distance/time and then
stop for a certain amount of time). In some instances, the timing
of the step-wise movement is coordinated with the patient's
heartbeat. In that regard, as discussed below some implementations
of the present disclosure rely on diagnostic windows corresponding
to only a portion of the patient's heartbeat cycle. Accordingly, in
some instances it is desirable to maintain the instrument 130 in a
fixed position for one or more heartbeat cycles before moving the
instrument 130 to a next position. However, in other instances the
instrument 130 is moved continuously through the vessel, while
still using only a portion of the patient's heartbeat cycle for the
diagnostic window. In some instances, the pullback device includes
some features similar to one or more of the pullback devices
disclosed in U.S. patent application Ser. No. 11/250,159, filed
Oct. 12, 2005, which is hereby incorporated by reference in its
entirety, the R100 Pullback Device available from Volcano
Corporation, the Trak Back.RTM.II Device available from Volcano
Corporation, and/or the SpinVision.RTM. Pullback Device available
from Volcano Corporation. To that end, generally the instrument 130
will not require rotation and, therefore, the components of such
pullback devices configured to impart rotation on the received
instrument (or a part thereof) are omitted and/or disabled in some
implementations.
[0037] 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. 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 time
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 an interface
170. In particular, in some instances the proximal end portion 162
is coupled to a pullback device 171 of the interface 170. The
pullback device 171 is incorporated into a housing of the interface
170 in some instances. In other instances, the pullback device 171
is in a separate housing from the interface 170, but in
communication with one or more electronic components of the
interface 170. Interface 170 is a patient interface module (PIM) in
some, instances. In some instances, the pullback device 171 and/or
adjacent component of the interface 170 include electrical
connectors to facilitate communication of data and/or signals
between the instrument 152 and the interface 170. In some
instances, the instrument 152 communicates data and/or signals
wirelessly with one or more components of the interface 170. 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.
[0038] The interface 170 is communicatively coupled to a processing
system 172 having a display 173. Accordingly, the interface 170 and
any intervening connections facilitate communication between the
one or more sensors, transducers, and/or other monitoring elements
of the instrument 152 and the processing system 172. In that
regard, it is understood that any communication pathway between the
instrument 152 and the interface 170 may be including physical
connections (including electrical, optical, and/or fluid
connections), wireless connections, and/or combinations thereof.
Similarly, it is understood that any communication pathway between
the interface 170 and the processing system 172 may be utilized,
including physical connections (including electrical, optical,
and/or fluid connections), wireless connections, and/or
combinations thereof. Accordingly, it is understood that additional
components (e.g., connectors, antennas, routers, switches, etc.)
not illustrated in FIG. 4 may be included to facilitate
communication between the instrument 152, the interface 170, and
the processing system 172.
[0039] The system 150 also includes an instrument 176. In that
regard, in some instances instrument 176 is suitable for use as at
least one of instruments 130 and 132 discussed above. Accordingly,
in some instances the instrument 176 includes features similar to
those discussed above with respect to instruments 130 and 132. In
the illustrated embodiment, the instrument 176 is a catheter-type
device. In that regard, the instrument 176 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 176 includes a pressure sensor
configured to monitor a pressure within a lumen in which the
instrument 176 is positioned. In one particular embodiment,
instrument 176 is a pressure-sensing catheter that includes a fluid
column extending along its length. In such an embodiment, a
hemostasis valve is fluidly coupled to the fluid column of the
catheter, a manifold is fluidly coupled to the hemostasis valve,
and tubing extends 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 or in communication with a hemo system 174 having a
display 175. In other instances, the pressure sensor is a separate
component positioned between the instrument 176 and the hemo system
174. In some instances, the hemo system 174 includes features
similar to those found in Siemens AXIOM Sensis, Mennen Horizon XVu,
and Philips Xper IM Physiomonitoring 5.
[0040] As shown, the hemo system 174 is in communication with the
processing system 172 to facilitate the transfer of data and/or
signals between the systems. In particular, in some implementations
data obtained by instrument 152 is passed from processing system
172 to hemo system 174, while data obtained by instrument 176 is
passed from hemo system 174 to processing system 172. To that end,
in implementations where instrument 152 is utilized to obtain
pressure measurements at a point of interest or across a region of
interest within a vessel and instrument 176 is utilized to obtain a
reference pressure measurement (e.g., an aortic pressure
measurement, in some instances), the combined data from the
instruments 152 and 176 can be utilized to calculate FFR and/or
similar pressure ratio calculation. For example, in some instances
FFR or similar pressure ratio calculation is determined for
pressure measurements obtained during a pullback of the instrument
152 using pullback device 171. In this manner, the resulting FFR or
similar pressure ratio calculation provides an indication of
severity of a stenosis or lesion along the length of the vessel
that the instrument 152 has been moved through during the pullback.
Such information can be utilized to determine an appropriate
treatment plan, including the determination of the type(s) of
treatment(s) to be applied and where such treatment(s) should be
utilized.
[0041] In some embodiments, the connection(s) between the
instrument 152, the interface 170, the processing system 172, and
the hemo system 174 includes a wireless connection. In some
instances, the connection(s) 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
processing system 172 and/or hemo system 174 is positioned remote
from an operating area where the instrument 152 is being used in
some instances. Having the connection(s) include a connection over
a network can facilitate communication between e instrument 152 and
the remote processing system 172 and/or remote hemo system 174
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(s) 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(s) is encrypted.
[0042] 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.
Alternatively, additional components and/or devices may be
implemented into the system. Generally speaking, the communication
pathway between either or both of the instruments 152, 176 and the
computing device 173 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.
[0043] In some embodiments, the interface 170 includes a processor
and random access memory and is programmed to execute steps
associated with the data acquisition and analysis described herein.
For example, in some embodiments the interface 170 is configured to
receive and display pressure readings from one or both of the
instruments 152 and 176 and/or calculate (and display) FFR or other
pressure ratio based on the pressure measurements obtained from the
instruments 152 and 176. Accordingly, in some instances the data
obtained by instrument 176 is passed through hemo system 174 and
processing system 172 to interface 170. However, as discussed below
with respect to FIGS. 5 and 6, other systems of the present
disclosure allow the interface 170 to obtain the data from
instrument 176 more directly. 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, including those incorporated by reference, may be
implemented by the interface 170 using corresponding instructions
stored on or in a non-transitory, computer readable medium
accessible by the computing device. In some embodiments, the
interface 170 includes one or more processing and/or signal
conditioning features and/or associated components/circuitry as
described in U.S. Pat. No. 6,585,660, which is hereby incorporated
by reference in its entirety.
[0044] In the illustrated embodiment of FIG. 4, the interface 170
includes a housing 180. The housing 180 contains the electronic
components of the interface 170. Exemplary embodiments of
electronic component arrangements suitable for interface 170 are
described below with respect to FIGS. 7-9. In some embodiments, the
interface 170 is sized to be handheld and/or sized to be positioned
on or near a patient bed (e.g., attached to a bed rail or IV pole).
In that regard, in some instances the interface 170 is similar in
size to the SmartMap.RTM. Pressure Instrument available from
Volcano Corporation, which has housing dimensions of approximately
15.75 cm (6.3'') wide, 8.853 cm (3.54'') tall, and 4.48 cm (1.79'')
deep. Generally, the interface 170 has a width between about 5 cm
and about 25 cm, a height between about 5 cm and about 25 cm, and a
depth between about 1 cm and about 10 cm.
[0045] The interface 170 also includes a display 182 and buttons
184. In that regard, the display 182 is configured to display
various diagnostic information such as distal pressure, proximal
pressure, pressure differentials (including FFR), distal pressure
waveforms, proximal pressure waveforms, and/or additional
diagnostic parameters. In some embodiments, in order to conserve
the amount of energy needed for operation of the interface 170, the
display 182 is a low-power display, such as a liquid crystal
display. However, any type of visual display may be utilized,
including color and/or monochromatic displays. In some instances,
the display 182 covers a majority of a front surface of the
display. In that regard, in some particular embodiments the display
182 is a touchscreen. In such embodiments, the buttons 184 may be
virtual buttons (i.e., displayed on the touchscreen display 182),
physical buttons, and/or combinations thereof. Generally, the
buttons 184 are configured to facilitate configuration and
operation of the interface 170 and/or pullback device 171. It is
understood that any number of buttons may be utilized and that
buttons may be utilized for multiple functionalities and/or be
dedicated to a single function. As a result, the interface 170 may
include one or more virtual or physical buttons configured to
facilitate use of the interface in the manners described herein.
Further, in some instances, in addition to or in lieu of display
182 the interface 170 includes a video output configured to send
video/display signals to a separate display device (e.g., display
173 of the processing system 172, display 175 of the hemo system
174, a standalone display, and/or a display integrated with another
medical system).
[0046] Referring now to FIG. 5, shown therein is a system 186
according to another embodiment of the present disclosure. In that
regard, FIG. 5 is a diagrammatic, schematic view of the system 186.
The system 186 includes many components and features similar to
system 150 described above. Accordingly, the following description
will focus on the differences of system 186. As shown, the
interface 170 of system 186 is communicates directly with hemo
system 174, rather than needing to communicate through processing
system 172. To that end, in some instances the interface 170 is
configured to output pressure measurements obtained by instrument
152 to the hemo system 174. The interface 170 is also configured to
output the pressure measurements obtained by instrument 152 to the
processing system 172. Further, in some instances the interface 170
is configured to receive pressure measurements obtained by
instrument 176 from the hemo system 174. In some instances, the
interface utilizes the pressure measurements obtained by the
instruments 152 and 176 to make FFR or other pressure ratio
calculations, including during a pullback of instrument 152.
Further, in some implementations the interface outputs the pressure
measurements of instrument 176 received from hemo system 174 to the
processing system 172.
[0047] Referring now to FIG. 6, shown therein is a system 188
according to another embodiment of the present disclosure. In that
regard, FIG. 6 is a diagrammatic, schematic view of the system 188.
The system 188 includes many components and features similar to
systems 150 and 186 described above. Accordingly, the following
description will focus on the differences of system 188. As shown,
in the embodiment of FIG. 6 the interface 170 is configured to
interface with both instruments 152 and 176. Accordingly, in some
instances the interface 170 is configured to communicate data
obtained by each of instruments 152 and 176 to the processing
system 171, which is a hemo system in some implementations. To that
end, in some instances the interface 170 includes different outputs
to the processing system 171 for each of the instruments 152 and
176. In other instances, the data for both instruments 152 and 176
are sent over a common, shared output from interface 170. Exemplary
implementations of the interface 170 in accordance with the
schematic of system 188 are described below.
[0048] Referring now to FIG. 7, shown therein is a schematic of the
interface 170 according to an exemplary embodiment of the present
disclosure. In that regard, the interface 170 includes an input
connector 190 associated with the pullback device 171 for receiving
a proximal end of instrument 152. Accordingly, in some embodiments
with an arrangement similar to that shown in FIG. 6, input
connector 190 is configured to receive the proximal end of the
instrument 152 and facilitate communication of signals to and from
a distal pressure sensing component 191 of the instrument 152. The
interface 170 also includes an output connector 192 configured to
send a distal pressure signal to a distal pressure input 193 of a
processing system 172, hemo system 174, or other computing device.
Accordingly, in some embodiments with an arrangement similar to
that shown in FIG. 6, output connector 192 is configured to send
the distal pressure signal to an input of processing system 172. In
that regard, in some embodiments processing system 172 is a hemo
system and the distal pressure signal is modulated based on the
hemo system's excitation voltage to provide a low level output of
the distal pressure signal to the hemo system. A low level output
in this context is typically 5 .mu.V/Vexc/mmHg, where Vexc is the
excitation voltage. However, larger or smaller level outputs are
used in some instances.
[0049] In some embodiments, the output connector 192 is also used
to facilitate energy harvesting from the processing system, hemo
system, or other pressure measuring system. In that regard, to
eliminate the need for an additional power supply within the
interface 170, a power supply circuit 220 extracts a small amount
of power from the system's excitation voltage associated with the
distal pressure input 193. The power supply circuit 220 converts
the extracted energy into the power needed to run the remaining
circuitry of the interface 170. In some instances, the power supply
circuit 220 is configured to be the only power source used to power
the components of interface 170. Since the excitation signal can be
AC, positive or negative DC, anti/or have various wave form shapes
and voltages, the power supply circuit 220 must be able to accept
these and convert to a regulated power supply. In that regard, the
voltage extracted from the excitation signal is converted to a
regulated Vcc voltage to operate the low power circuitry using a
buck or boost regulator depending on the input voltage. A current
limiter minimizes distortion to the system's waveform at the peaks.
In some instances, the current is limited to a level below the AAMI
transducer limits as to be compatible with most hemo systems. In
sonic instances, the system's excitation voltage meets the IEC
60601-2-34 standard. In some alternative embodiments, the power
supply circuit is configured to interface with a battery or other
rechargeable power supply device that can be utilized to power the
components of the interface. In some alternative embodiments, the
power supply circuit is configured to interface with an AC adapter
that is to be plugged into a wall outlet in order to provide power
to the components of the interface.
[0050] The interface 170 also includes an input/output connectors
194 and 195 for interfacing with a proximal pressure measurement
system. In some particular embodiments, the input/output connectors
194 and 195 are configured to work with a pressure monitoring
device of a hemo stat system. Generally, the input/output connector
194 is configured to receive signals from a proximal pressure
sensing component 196. Accordingly, in some embodiments with an
arrangement similar to that shown in FIG. 6, input/output connector
194 is configured to receive signals from instrument 176, where the
proximal pressure sensing component 196 is a pressure sensing
component associated with the instrument 176. The input/output
connector 195 is configured to send a proximal pressure signal to a
proximal pressure input 197 of a processing system, hemo system, or
other computing device. Accordingly, in some embodiments with an
arrangement similar to that shown in FIG. 6, the input/output
connector 195 is configured to send the proximal pressure signal to
an input of computing device 173 over connection 178.
[0051] In the illustrated embodiment of FIG. 7, conductors 200 and
202 carry the excitation signal to the proximal pressure sensing
component 196. An amplifier 204 is electrically connected to the
conductors 200 and 202 as shown. The amplifier 204 is an
operational amplifier in some embodiments. The excitation signal
extracted by amplifier 204 is sent to a microprocessor 206. As will
be discussed below, the excitation signal is utilized to evaluate
the proximal pressure signals received from the proximal pressure
sensing component 196.
[0052] In the illustrated embodiment of FIG. 7, conductors 208 and
210 carry the proximal pressure signal from the proximal pressure
sensing component 196 back to the proximal pressure input 197 of
the computing device. In that regard, an amplifier 212 is
electrically connected to the conductors 208 and 210 as shown. The
amplifier 212 is an operational amplifier in some embodiments. The
amplifier 212 is configured to monitor or sample the proximal
pressure signal being supplied from the proximal pressure sensing
component 196. The sampled proximal pressure signal is then sent to
the microprocessor 206. Accordingly, both the excitation
signal/voltage sampled from conductors 200 and 202 and the proximal
pressure signal sampled from conductors 208 and 210 are fed to the
microprocessor 206. In some instances, the microprocessor 206
calculates the proximal pressure based on the excitation signal
voltage (Vexc), and the proximal pressure sensing component's
output. In that regard, the proximal pressure sensing component's
output conforms to the AAMI standard of 5 uV/Vexc/mmHg in some
instances. For an AC excitation signal, the microprocessor 206 must
measure the proximal pressure signal voltage in synchrony with the
excitation waveform. In some instances, rather than the low-level
inputs described above, the proximal pressure signal is received by
the interface 170 as a high level signal. For example, the proximal
pressure signal is a high level signal from a Volcano LoMap
(available from Volcano Corporation) or from an external hemo
system.
[0053] In some embodiments, the input/output connectors 194 and 195
are also used to facilitate energy harvesting from the hemo system
or other pressure measuring system. In that regard, to eliminate
the need for an additional power supply within the interface 170,
the power supply circuit 220 may be connected to conductors 200 and
202 and utilized to extract a small amount of power from the hemo
system's excitation voltage for the proximal pressure sensing
component 196 and convert it into the power needed to run the
remaining circuitry of the interface 170. As noted above, when
connected to the proximal pressure sensing side the power supply
circuit 220 is still configured to extract power from the
excitation signal sent from the controller/computing device such
that the extracted power can be used to power the components of
interface 170. Since the excitation signal can be AC, positive or
negative DC, and/or have various wave form shapes and voltages, the
power supply circuit 220 must be able to accept these and convert
to a regulated power supply without distorting the waveform that
continues on to the proximal pressure sensing component 196. This
is necessary to avoid affecting the pressure measurements obtained
by the proximal pressure sensing component 196. The voltage
extracted from the excitation signal is converted to a regulated
Vcc voltage to operate the low power circuitry using a buck or
boost regulator depending on the input voltage.
[0054] As noted above, the interface 170 is also configured to
receive and process distal pressure signals from a distal pressure
sensing component 191 of instrument 152. In that regard, a signal
conditioning portion 216 of the interface 170 is in communication
with input 190 that receives the distal pressure signal. Referring
now to FIG. 8, shown therein is a schematic of a portion the
interface 170 according to an exemplary embodiment of the present
disclosure. In particular, FIG. 8 shows a schematic of an exemplary
embodiment of signal conditioning portion 216 of the interface 170.
In that regard, the signal conditioning portion 216 is configured
to condition signals received from the distal pressure measurement
device. The signal conditioning portion 216 provides the excitation
and amplification required for the distal pressure measurement
device's pressure sensors, Ra and Rb, which collective form distal
pressure sensing component 191 in some instances. In some
implementations, the signal conditioning portion 216 is
incorporated as part of the pullback device 171. In other
implementations, the signal conditioning portion is adjacent to or
spaced from the pullback device 171.
[0055] Calibration coefficients provided by the distal pressure
measurement device utilizing an EPROM in the device connector, for
example, are read to adjust the gain, offset, and temperature
sensitivity for the device. The read values are used to adjust the
three Digital to Analog Converters (DACs) 224, 226, and 228, in the
distal pressure front end circuitry 216 that control the gain,
offset, and temperature (TC) compensation, respectively. The distal
pressure signal is then digitized with an Analog to Digital
Converter 230, ADC, and sent to the microprocessor 206. The
microprocessor 206 can then display the distal pressure, display a
waveform of the distal pressure, or utilize the distal pressure or
the distal pressure waveform for additional calculations. For
example, in some instances the microprocessor utilizes the distal
pressure and/or distal pressure waveform with the proximal pressure
and/or proximal pressure waveform to calculate FFR, calculate a
pressure differential between the proximal and distal pressures,
identify a suitable diagnostic window for performing a pressure
differential calculation without administering a hyperemic agent to
the patient, calculate a pressure differential during the
identified diagnostic window, and/or combinations thereof.
[0056] Referring now to FIG. 9, shown therein is a schematic of a
portion the interface 170 according to another exemplary embodiment
of the present disclosure. In particular, FIG. 9 shows a schematic
of an exemplary embodiment of signal conditioning portion 216' of
the interface 170. In that regard, the signal condition portion
216' is configured to condition signals received from the distal
pressure measurement device. The signal conditioning portion 216'
provides the excitation and amplification required for the distal
pressure measurement device's pressure sensors, Ra and Rb, which
collective form distal pressure sensing component 191 in some
instances. The distal pressure signal from the pressure sensors, Ra
and Rb, is digitized with a two-channel Analog to Digital Converter
230, ADC, and sent to the microprocessor 206 for the gain, offset,
and/or temperature compensation. Calibration coefficients provided
by the distal pressure measurement device utilizing an EPROM 222 in
the device connector, for example, are read to adjust the gain,
offset, and/or temperature sensitivity for the device. The read
values are used by the microprocessor 206 to control the gain,
offset, and/or temperature compensation. Firmware within the
microprocessor is utilized to control these parameters in some
instances. The microprocessor 206 can then display the distal
pressure, display a waveform of the distal pressure, or utilize the
distal pressure or the distal pressure waveform for additional
calculations. For example, in some instances the microprocessor
utilizes the distal pressure and/or distal pressure waveform with
the proximal pressure and/or proximal pressure waveform to
calculate FFR, calculate a pressure differential between the
proximal and distal pressures, identify a suitable diagnostic
window for performing a pressure differential calculation without
administering a hyperemic agent to the patient, calculate a
pressure differential during the identified diagnostic window,
and/or combinations thereof. Accordingly, the signal conditioning
portion 216' of FIG. 9 provides similar functionality to the signal
conditioning device 216 of FIG. 8, but without the need for the
three Digital to Analog Converters (DACs) 224, 226, and 228.
[0057] Referring again to FIG. 7, the interface 170 is also
configured to output the distal pressure signal to an input 193 of
a computing device. In that regard, the microprocessor 206 provides
a digitized signal to an additional set of DACs in the distal
output circuitry 218 that modulate the excitation of the hemo
system to provide a proportional distal waveform of the distal
pressure voltage back to the hemo system through output 192. In
some embodiments, the scaled voltage returned is the same as a
standard proximal pressure transducer, 5 uV/Vexc/mmHg, per the AAMI
standards. The output stage 218 modulates the external excitation
of the hemo system to provide a duplicate wave shape, or a DC
voltage, scaled to 5 .mu.V/Vexc/mmHg, per AAMI standards for aortic
transducers of the distal pressure for the hemo system.
Accordingly, by outputting the distal pressure signal through
output 192 and the proximal pressure signal through output 196,
both proximal and distal pressures can then be observed on the hemo
system's display using the hemo system's standard low-level
inputs.
[0058] As noted above, the interface 170 uses the proximal and
distal pressure data received from the instruments to calculate and
display information that can be useful in the evaluation of the
vessel and, in particular, evaluation of a stenosis of the vessel.
In some instances, the interface is configured to calculate and
display FFR or other pressure ratio. For an FFR measurement, the
microprocessor first normalizes the distal pressure to the aortic
pressure. The difference or ratio between the distal and aortic
pressures is utilized to determine FFR or pressure ratio. Further,
in some instances the FFR or pressure ratio is calculated as at
least the pressure sensing clement of instrument 152 is moved
through the vessel. Accordingly, in some instances the FFR or
pressure ratio is tracked relative to movement of the pressure
sensing element of instrument 152, for example, based on time or
distance. To that end, information about the movement of the
pressure sensing element of instrument 152 relative to the vessel
and/or instrument 176 is obtained based on the motion, and
associated timing of such motion, imparted by the pullback device
171. By correlating the difference or ratio between the two
pressures to the movement associated with the pullback, a pressure
ratio map or visual representation of the vessel can be created.
For example, FIG. 10 provides a graphical representation of
proximal and distal pressure measurements over time during a
pullback of instrument 152 according to an embodiment of the
present disclosure. FIG. 11 provides a graphical representation of
the proximal and distal pressure measurements during the pullback
of the instrument 152 of FIG. 10, but illustrates the proximal and
distal pressure measurements relative to a distance according to an
embodiment of the present disclosure. The resultant FFR or pressure
ratio data (and associated positional/timing information) is stored
in memory for later retrieval and/or shown on a display in real
time.
[0059] In some embodiments the interface 170 includes
user-controlled buttons, such as buttons 184 shown in FIGS. 4-6, in
one particular embodiment, one of the buttons causes the
microprocessor to `normalize` the distal pressure measurement to
the proximal pressure measurement. This is typically performed with
the pressure sensing components 191 and 196 positioned in close
proximity to one another within the patient such that they are
subjected to similar pressures. In some instances, this calibration
is performed proximal of the lesion and before the distal pressure
sensing component 191 is advanced distally beyond the lesion. After
the distal pressure sensing component 191 is placed beyond the
suspect lesion actuation of another button causes the
microprocessor 206 to calculate the ratio of the distal pressure to
the proximal pressure, which provides an FFR value or pressure
differential. In that regard, in some implementations the button is
pressed by a user at a precise moment during hyperemia based on
observation of the proximal and distal waveforms, which may be
displayed on a separate device (e.g., a display of the hemo system)
or displayed on display 182 of interface 170. Alternatively, the
determination of the appropriate moment for the FFR calculation can
be done automatically by the microprocessor 206. In that regard, in
some instances the FFR calculation is performed at a point
coinciding with the peak difference between the distal and proximal
(aortic) pressures. In some embodiments, a pressure differential is
calculated during a diagnostic window without application of a
hyperemic agent, as discussed below. In such embodiments, the
pressure measurements and/or the pressure differential may be
displayed continuously. Further, in some instances a
user-controlled button is utilized to start a pullback. In
particular, actuation of the user-controlled button initiates the
pullback device 171. In some instances, a single button is utilized
to both initiate a pullback sequence and cause the microprocessor
206 to calculate the ratio of the distal pressure to the proximal
pressure.
[0060] In some instances the interface 170 is configured to provide
pressure measurements and/or pressure differentials based on
evaluation techniques as described in one or more of UK Patent
Application Publication No. GB 2479340 A, filed Mar. 10, 2010 and
titled "METHOD AND APPARATUS FOR THE MEASUREMENT OF A FLUID FLOW
RESTRICTION IN A VESSEL", UK Patent Application No. GB1100137.7,
filed Jan. 6, 2011 and titled "APPARATUS AND METHOD OF ASSESSING A
NARROWING IN A FLUID FILLED TUBE", U.S. Provisional Patent
Application No. 61/525,739, filed on Aug. 20, 2011 and titled
"DEVICES, SYSTEMS AND METHODS FOR ASSESSING A VESSEL," and U.S.
Provisional Patent Application No. 61/525,736, filed on Aug. 20,
2011 and titled "DEVICES, SYSTEMS, AND METHODS FOR VISUALLY
DEPICTING A VESSEL AND EVALUATING TREATMENT OPTIONS," each of which
is hereby incorporated by reference in its entirety.
[0061] In some embodiments, the interface 170 is utilized to
calculate and display FFR in a traditional FFR procedure where the
patient is administered a hyperemic agent. In other embodiments,
the interface 170 is utilized to calculate a pressure differential
similar to FFR (i.e., the ratio of distal pressure to proximal
pressure) but without the use of a hyperemic agent, including
during a pullback in some implementations. In that regard, a
suitable diagnostic window for making such calculations must be
determined and/or identified to have a useful measurement. The
diagnostic window for evaluating differential pressure across a
stenosis without the use of a hyperemic agent in accordance with
the present disclosure may be 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] In some embodiments, the determination of the diagnostic
window and/or the calculation of the pressure differential are
performed in approximately real time or live to identify the
diagnostic window and calculate the pressure differential. In that
regard, calculating the pressure differential in "real time" or
"live" within the context of the present disclosure is understood
to encompass calculations that occur within 10 seconds of data
acquisition. It is recognized, however, that often "real time" or
"live" calculations are performed within 1 second of data
acquisition. In some instances, the "real time" or "live"
calculations are performed concurrent with data acquisition. In
some instances the calculations are performed by a processor in the
delays between data acquisitions. For example, if data is acquired
from the pressure sensing devices for 1 ms every 5 ms, then in the
4 ms between data acquisitions the processor can perform the
calculations. It is understood that these timings are for example
only and that data acquisition rates, processing times, and/or
other parameters surrounding the calculations will vary. In other
embodiments, the pressure differential calculation is performed 10
or more seconds after data acquisition. For example, in some
embodiments, the data utilized to identify the diagnostic window
and/or calculate the pressure differential are stored for later
analysis.
[0063] In some instances, the diagnostic window is selected by
identifying a portion of the cardiac cycle corresponding to a time
period in which the change in velocity (i.e., dU) fluctuates around
zero. Time periods where the change in velocity is relatively
constant and approximately zero (i.e., (he speed of the fluid flow
is stabilized) are suitable diagnostic windows for evaluating a
pressure differential across a stenosis of a vessel without the use
of a hyperemic agent in accordance with the present disclosure. In
that regard, in a fluid flow system, the separated forward and
backward generated pressures are defined by:
P + = 1 2 ( P + .rho. cdU ) and P - = 1 2 ( P - .rho. cdU ) ,
##EQU00001##
where dP is the differential of pressure, .rho. is the density of
the fluid within the vessel, c is the wave speed, and dU is the
differential of flow velocity. However, where the flow velocity of
the fluid is substantially constant, dU is approximately zero and
the separated forward and backward generated pressures are defined
by:
P + = 1 2 ( P + .rho. c ( 0 ) ) = 1 2 P and P - = 1 2 ( P - .rho. c
( 0 ) ) = 1 2 P . ##EQU00002##
In other words, during the time periods where dU is approximately
zero, the forward and backward generated pressures are defined
solely by changes in pressure.
[0064] Accordingly, during such time periods the severity of a
stenosis within the vessel can be evaluated based on pressure
measurements taken proximal and distal of the stenosis. In that
regard, by comparing the forward and/or backward generated pressure
distal of a stenosis to the forward and/or backward generated
pressure proximal of the stenosis, an evaluation of the severity of
the stenosis can be made. For example, the forward-generated
pressure differential can be calculated as
P + distal P + proximal , ##EQU00003##
while the backward-generated pressure differential can be
calculated as
P - distal P - proximal . ##EQU00004##
[0065] In the context of the coronary arteries, a forward-generated
pressure differential is utilized to evaluate a stenosis in some
instances. In that regard, the forward-generated pressure
differential is calculated based on proximally originating (i.e.,
originating from the aorta) separated forward pressure waves and/or
reflections of the proximally originating separated forward
pressure waves from vascular structures distal of the aorta in some
instances. In other instances, a backward-generated pressure
differential is utilized in the context of the coronary arteries to
evaluate a stenosis. In that regard, the backward-generated
pressure differential is calculated based on distally originating
(i.e., originating from the microvasculature) separated backward
pressure waves and/or reflections of the distally originating
separated backward pressure waves from vascular structures proximal
of the microvasculature.
[0066] In yet other instances, a pressure wave is introduced into
the vessel by an instrument or medical device. In that regard, the
instrument or medical device is utilized to generate a proximally
originating forward pressure wave, a distally originating backward
pressure wave, and/or combinations thereof for use in evaluating
the severity of the stenosis. For example, in some embodiments an
instrument having a movable membrane is positioned within the
vessel. The movable membrane of the instrument is then activated to
cause movement of membrane and generation of a corresponding
pressure wave within the fluid of the vessel. Based on the
configuration of the instrument, position of the membrane within
the vessel, and/or the orientation of the membrane within the
vessel the generated pressure wave(s) will be directed distally,
proximally, and/or both. Pressure measurements based on the
generated pressure wave(s) can then be analyzed to determine the
severity of the stenosis.
[0067] There are a variety of signal processing techniques that can
be utilized to identify time periods where the change in velocity
is relatively constant and approximately zero, including using a
differential, first derivative, second derivative, and/or third
derivative of the velocity measurement are utilized. For example,
identifying time periods during the cardiac cycle where the first
derivative of velocity is relatively constant and approximately
zero allows the localization of time periods where velocity is
relatively constant. Further, identifying time periods during the
cardiac cycle where the second derivative of velocity is relatively
constant and approximately zero allows the localization of a time
period where acceleration is relatively constant and near zero, but
not necessarily zero.
[0068] While examples of specific techniques for selecting a
suitable diagnostic window have been described above, it is
understood that these are exemplary and that other techniques may
be utilized. In that regard, it is understood that the diagnostic
window is determined using one or more techniques selected from:
identifying a feature of a waveform or other data feature and
selecting a starting point relative to the identified feature
(e.g., before, after, or simultaneous with the feature);
identifying a feature of a waveform or other data feature and
selecting an ending point relative to the identified feature (e.g.,
before, after, or simultaneous with the feature); identifying a
feature of a waveform or other data feature and selecting a
starting point and an ending point relative to the identified
feature; identifying a starting point and identifying an ending
point based on the starting point; and identifying an ending point
and identifying a starting point based on the ending point.
Additional details of techniques for selecting a suitable
diagnostic window are described in U.S. Provisional Patent
Application No. 61/525,739, filed on Aug. 20, 2011 and titled
"DEVICES, SYSTEMS AND METHODS FOR ASSESSING A VESSEL," which is
hereby incorporated by reference in its entirety. In that regard,
it is understood that the interface 170 may be programmed to
determine one or more diagnostic windows based on the techniques
described in the present disclosure, including those incorporated
by reference, and/or include one or more hardware features
configured to identify one or more diagnostic windows based on the
techniques described in the present disclosure, including those
incorporated by reference.
[0069] Further, for a variety of reasons the proximal pressure
measurements and the distal pressure measurements received by the
interface 170 are not temporally aligned in some instances. For
example, during data acquisition, there will often be a delay
between the distal pressure measurement signals and the proximal
pressure measurement signals due to hardware signal handling
differences between the instrument(s) utilized to obtain the
measurements. In that regard, the differences can come from
physical sources (such as cable length and/or varying electronics)
and/or can be due to signal processing differences (such as
filtering techniques). The resulting delay between the signals is
between about 5 ms and about 150 ms in some instances. Because
individual cardiac cycles may last between about 500 ms and about
1000 ms and the diagnostic window may be a small percentage of the
total length of the cardiac cycle, longer delays between the
proximal and distal pressure measurement signals can have a
significant impact on alignment of the pressure data for
calculating a pressure differential for a desired diastolic window
of a cardiac cycle.
[0070] As a result, in some instances, it is necessary to shift one
of the proximal and distal pressures relative to the other of the
distal and proximal pressures in order to temporally align the
pressure measurements. For example, a portion of the distal
pressure measurement or proximal pressure measurement may be
shifted to be temporally aligned with a corresponding portion of
the proximal pressure measurement or distal pressure measurement,
respectively, coinciding with the diagnostic window. While a shift
of only a portion of the distal or proximal pressure measurement
associated with the diagnostic window is utilized in some
instances, in other instances all or substantially all of the
proximal and distal pressures are aligned before the portions
corresponding to a selected diagnostic window are identified.
[0071] Alignment of all or portion(s) of the proximal and distal
pressures is accomplished using a hardware approach in some
instances. For example, one or more hardware components are
positioned within the communication path of the proximal pressure
measurement, the distal pressure measurement, and/or both to
provide any necessary delays to temporally align the received
pressure signals. In some instances, these hardware components are
positioned within the interface 170. In other instances, alignment
of all or portion(s) of the proximal and distal pressures is
accomplished using a software approach. For example, a
cross-correlation function or matching technique is utilized to
align the cardiac cycles in some embodiments. In other embodiments,
the alignment is based on a particular identifiable feature of the
cardiac cycle, such as an ECG R-wave or a pressure peak.
Additionally, in some embodiments alignment is performed by a
software user where adjustments are made to the delay time of at
least one of the proximal and distal pressures until the cardiac
cycles are visually aligned to the user. A further technique for
aligning the signals is to apply a synchronized timestamp at the
point of signal acquisition. Further, in sonic instances
combinations of one or more of hardware, software, user, and/or
time-stamping approaches are utilized to align the signals.
[0072] Regardless of the manner of implementation, several
approaches are available for the aligning the proximal and distal
pressure measurement signals. In some instances, each individual
distal pressure measurement cardiac cycle is individually shifted
to match the corresponding proximal pressure measurement cardiac
cycle. In other instances, an average shift for a particular
procedure is calculated at the beginning of the procedure and all
subsequent cardiac cycles during the procedure are shifted by that
amount. This technique requires little processing power for
implementation after the initial shift is determined, but can still
provide a relatively accurate alignment of the signals over the
course of a procedure because the majority of the signal delay is
due to fixed sources that do not change from patient to patient or
within the procedure. In yet other instances, a new average shift
is calculated each time that the proximal and distal pressure
signals are normalized to one another during a procedure. In that
regard, one or more times during a procedure the sensing element
utilized for monitoring pressure distal of the stenosis is
positioned adjacent the sensing element utilized for monitoring
pressure proximal of the stenosis such that both sensing elements
should have the same pressure reading. If there is a difference
between the pressure readings, then the proximal and distal
pressure signals are normalized to one another. As a result, the
subsequently obtained proximal and distal pressure measurements are
more consistent with each other and, therefore, the resulting
pressure differential calculations are more accurate.
[0073] With the proximal and distal pressure measurements aligned,
the pressure differential for the diagnostic window is calculated.
In some instances, the pressure differential is calculated using
average values for the proximal and distal pressure measurements
across the diagnostic window. The pressure differential
calculations of the present disclosure are performed for a single
cardiac cycle, in some instances. In other instances, the pressure
differential calculations are performed for multiple cardiac
cycles. In that regard, accuracy of the pressure differential can
be improved by performing the pressure differential calculations
over multiple cardiac cycles and averaging the values and/or using
an analysis technique to identify one or more of the calculated
values that is believed to be most and/or least accurate.
[0074] One advantage of the techniques of the present disclosure
for identifying diagnostic windows and evaluating pressure
differentials is the concept of "beat matching". In that regard,
the proximal and distal waveforms for the same cardiac cycle are
analyzed together with no averaging or individual calculations that
span more than a single cardiac cycle. As a result, interruptions
in the cardiac cycle (such as ectopic heartbeats) equally affect
the proximal and distal recordings. As a result, these
interruptions that can be detrimental to current FFR techniques
have minor effect on the techniques of the present disclosure.
Further, in some embodiments of the present disclosure, the effect
of interruptions in the cardiac cycle and/or other irregularities
in the data is further minimized and/or mitigated by monitoring the
pressure differential calculations to detect these anomalies and
automatically exclude the impacted cardiac cycles.
[0075] In one particular embodiment, pressure differential is
calculated on two sequential cardiac cycles and the individual
pressure differential values are averaged. The pressure
differential of a third cycle is then calculated. The average value
of the pressure differentials is compared to the average pressure
differential using three cycles. If the difference between the
averages is below a predetermined threshold value, then the
calculated value is considered to be stable and no further
calculations are performed. For example, if a threshold value of
0.001 is used and adding an additional cardiac cycle changes the
average pressure differential value by less than 0.001, then the
calculation is complete. However, if the difference between the
averages is above the predetermined threshold value, then the
pressure differential for a fourth cycle is calculated and a
comparison to the threshold value is performed. This process is
repeated iteratively until the difference between the averages of
cardiac cycle N and cardiac cycle N+1 is below the predetermined
threshold value. As the pressure differential value is typically
expressed to two decimal places of precision (such as 0.80), the
threshold value for completing the analysis is typically selected
to be small enough that adding a subsequent cardiac cycle will not
change the pressure differential value. For example, in some
instances the threshold value is selected to be between about
0.0001 and about 0.05.
[0076] In some instances, the level of confidence calculation has
different thresholds depending on the degree of stenosis and/or an
initial calculated pressure differential value. In that regard,
pressure differential analysis of a stenosis is typically based
around a cutoff value(s) for making decisions as to what type of
therapy, if any, to administer. Accordingly, in some instances, it
is desirable to be more accurate around these cutoff points. In
other words, where the calculated pressure differential values are
close to a cut-off, a higher degree of confidence is required. For
example, if the cutoff for a treatment decision is at 0.80 and the
initial calculated pressure differential measurement is between
about 0.75 and about 0.85, then a higher degree of confidence is
needed than if the initial calculated pressure differential
measurement is 0.40, which is far from the 0.80 cutoff point.
Accordingly, in some instances the threshold value is at least
partially determined by the initial calculated pressure
differential measurement. In some instances, the level of
confidence or stability of the calculated pressure differential is
visually indicated to user via a software interface.
[0077] Because pressure differential can be calculated based on a
single cardiac cycle in accordance with the present disclosure, a
real-time or live pressure differential calculation can made while
the distal pressure measuring device is moved through the vessel.
Accordingly, in some instances the system includes at least two
modes: a single-cardiac-cycle mode that facilitates pressure
differential calculations while moving the distal pressure
measuring device through the vessel and a multi-cardiac-cycle mode
that provides a more precise pressure differential calculation at a
discrete location. In one embodiment of such a system, the
interface 170 is configured to provide the live pressure
differential value until the distal pressure measuring device is
moved to the desired location and a measurement button is selected
and/or some other actuation step is taken to trigger the
multi-cardiac-cycle mode calculation.
[0078] 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.
* * * * *