U.S. patent application number 13/290438 was filed with the patent office on 2012-05-10 for multimodal catheter system and method for intravascular analysis.
This patent application is currently assigned to INFRAREDX. Invention is credited to James E. Muller, Mark A. Wilder.
Application Number | 20120116214 13/290438 |
Document ID | / |
Family ID | 40935497 |
Filed Date | 2012-05-10 |
United States Patent
Application |
20120116214 |
Kind Code |
A1 |
Muller; James E. ; et
al. |
May 10, 2012 |
Multimodal Catheter System and Method for Intravascular
Analysis
Abstract
Methods, apparatus, and systems for intravascular analysis
combine at least three analytical modalities. In one
implementation, intravascular ultrasound, optical coherence
tomography, and near infrared spectroscopy are combined to enable
detection of multiple, different abnormalities in the arterial
morphology during a single intravascular procedure.
Inventors: |
Muller; James E.;
(Auburndale, MA) ; Wilder; Mark A.; (Lexington,
MA) |
Assignee: |
INFRAREDX
Burlington
MA
|
Family ID: |
40935497 |
Appl. No.: |
13/290438 |
Filed: |
November 7, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12437022 |
May 7, 2009 |
8052605 |
|
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13290438 |
|
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61051227 |
May 7, 2008 |
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Current U.S.
Class: |
600/424 ;
600/407 |
Current CPC
Class: |
A61B 5/0066 20130101;
A61B 8/12 20130101; A61B 5/02007 20130101; A61B 5/6852 20130101;
A61B 5/0075 20130101; A61B 5/0035 20130101; A61B 8/4416 20130101;
A61B 5/0086 20130101; A61B 5/0062 20130101; A61B 5/0095 20130101;
A61B 5/0071 20130101; A61B 8/4461 20130101 |
Class at
Publication: |
600/424 ;
600/407 |
International
Class: |
A61B 6/00 20060101
A61B006/00; A61B 8/14 20060101 A61B008/14; A61B 5/00 20060101
A61B005/00; A61B 8/12 20060101 A61B008/12 |
Claims
1. An intravascular catheter system comprising: at least one
optical fiber configured to transmit optical radiation between
distal and proximal ends thereof, wherein said distal end of said
optical fiber is in optical communication with an arterial wall; at
least one source of optical radiation optically coupled to a
portion of said optical fiber and configured to generate optical
radiation to be transmitted by said optical fiber to the arterial
wall; an interferometer optically coupled to a portion of said
optical fiber and configured to receive optical radiation
transmitted by said optical fiber from the arterial wall and to
provide an interference signal for sub-surface imaging of the
arterial wall; an optical processing module optically coupled to a
portion of said optical fiber and configured to receive optical
radiation transmitted by said optical fiber from the arterial wall
and to provide spectroscopic information about the arterial wall
from detected intensity of the light collected from the arterial
wall; an ultrasound transducer configured to transmit ultrasound
energy toward the arterial wall, receive ultrasound energy
reflected from the arterial wall, and convert the received
ultrasound energy to an electric signal; and an ultrasonic
subsystem in communication with said ultrasound transducer and
configured to generate an ultrasonic image from the electric
signal.
2. The intravascular catheter system of claim 1, wherein said at
least one optical fiber comprises a delivery fiber and a collection
fiber and wherein said at least one source is optically coupled
with a portion of said delivery fiber, said interferometer is
optically coupled to a portion of said delivery fiber and
configured to receive optical radiation transmitted by said
delivery fiber from the arterial wall, and said optical processing
module is optically coupled to a portion of said collection fiber
and configured to receive optical radiation transmitted by said
collection fiber from the arterial wall.
3. The intravascular catheter system of claim 2, wherein said
delivery fiber is a single mode optical fiber configured to
propagate only a single spatial mode and said collection fiber
comprises a multimode fiber.
4. The intravascular catheter system of claim 1, further comprising
at least one reflector configured to redirect optical radiation
from said distal end of said optical fiber toward the arterial wall
and to redirect at least a portion of the optical radiation from
the arterial wall toward said distal end of said fiber.
5. The intravascular catheter system of claim 1, wherein said at
least one optical radiation source comprises one or both of a
tunable laser and a super luminescent light emitting diode.
6. The intravascular catheter system of claim 1, wherein said
ultrasound transducer is configured to employ time multiplexing to
both transmit ultrasound energy toward the arterial wall and
receive ultrasound energy from the arterial wall.
7. The intravascular catheter system of claim 1, further comprising
one or more wires providing an electrical connection between said
ultrasound transducer and said ultrasonic subsystem.
8. The intravascular catheter system of claim 1, further comprising
an outer sheath covering at least a portion of said optical
fiber.
9. The intravascular catheter system of claim 8, further comprising
a guide wire coupled to a portion of said sheath and configured to
guide movement of said sheath and said optical fiber through an
intravascular lumen.
10. The intravascular catheter system of claim 1, further
comprising a position detection system comprising an internal
element configured to be inserted into an intravascular lumen along
with said optical fiber and an external element disposed outside
the intravascular lumen, wherein said internal element and said
external element are configured for communication therebetween for
locating a position of said internal element relative to said
external element.
11. The intravascular catheter system of claim 1, wherein said at
least one optical fiber and said ultrasound transducer comprise a
catheter core, and wherein said system further comprises a torque
cable coupled to said catheter core and configured to transmit a
rotational force to a distal portion of said catheter core.
12. The intravascular catheter system of claim 11, further
comprising a pullback and rotation unit coupled to said torque
cable and configured to withdraw and rotate said optical fiber and
said ultrasound transducer within an intravascular lumen.
13. The intravascular catheter system of claim 12, wherein said
pullback and rotation unit is further configured to couple optical
signals from the rotating optical fiber to the non-rotating optical
processing module.
14. The intravascular catheter system of claim 1, wherein said
ultrasound transducer is distally spaced from said distal end of
said optical fiber.
Description
PRIORITY CLAIM
[0001] This application is a continuation of U.S. application Ser.
No. 12/437,022 (filed May 7, 2009), which claims the benefit under
35 U.S.C. 119(e) of U.S. Provisional Application Ser. No.
61/051,227, filed May 7, 2008, the disclosure of which is hereby
incorporated by reference.
BACKGROUND
[0002] Atherosclerosis is a vascular disease characterized by the
modification of the walls of blood carrying vessels. This
modification can take the form of thickening of the vessel wall,
eventually forming what are commonly referred to as "plaques." The
mechanisms corresponding to the formation, progression,
stabilization, or rupture of these plaques and their effects on
humans has been an area of intense research in intravascular
medicine. With the advent of interventional cardiology and
percutaneous diagnostic and treatment procedures, the patient with
coronary atherosclerotic disease was no longer required to
automatically submit to coronary by-pass surgery--an extremely
invasive procedure with attendant risks and extended recovery time.
Coronary stents were developed to revascularize narrowed (stenosed)
vessels and millions of theses devices have been placed in patients
worldwide. However, current statistics show that, while patient
comfort and quality of life has been improved, treatment of
coronary atherosclerotic disease by stenting has not significantly
reduced the patient mortality. Patients treated with stents are
still dying suddenly of heart attack.
[0003] Much more is now known about coronary disease than even a
decade ago, but there are still many questions to be answered. From
retrospective autopsy studies on heart attack victims, it has been
shown (ref Virmani) that there is often a portion of the coronary
artery tree that is completely blocked by a thrombosis, or blood
clot. The thrombosis is typically in the vicinity of a plaque in
the vessel wall. Referred to as the "culprit lesion," it would be
this blockage that would cut off the blood supply to a portion of
the heart, resulting in death of heart muscle tissue and possibly
death of the individual. Certain plaques contain material which,
when it comes into contact with blood, causes thrombogenesis, or
clot formation.
[0004] These plaques seem to have formed a reservoir, or core, of
thrombogenic material behind a layer of fibrous tissue ("cap"),
analogous to an abscess. Through some process or set of processes,
the integrity of the fibrous layer can become compromised, whereby
blood can eventually come into contact with the thrombogenic core.
This can be a sudden event, where the patient had no prior warning
or even symptoms. If one categorizes plaques broadly as
stable--where they may still progress slowly and eventually
restrict the vessel--and unstable--those that can change their
status rapidly, among the key questions is: "How can we tell the
difference?"
[0005] Historically, the search for atherosclerotic disease has
been a search for the narrowing in the opening or "lumen" of the
vessel. Angiography is one of the oldest intravascular technologies
employed for this purpose. The technique typically employs a
catheter, introduced percutaneously into the vasculature, that is
used to inject a contrast agent, consisting of a radio opaque dye,
into the blood vessels of interest. Using x-rays, a two dimensional
live (cine) or still image of the vasculature can be obtained. The
vessel lumen is visible wherever the contrast agent is able to
flow. From these images, one can determine the size of the lumen
and the presence of any narrowing or blockage. The presence of a
plaque can sometimes be inferred by a diffuse lumen boundary.
Despite being standard of care for many years and forming the basis
for most therapy decisions, angiography alone suffers from some
limitations. First, vessel narrowing is not necessarily
rotationally isotropic. With only a single view angle from which to
form the 2-D image, areas of narrowing can be underestimated or
missed entirely. To obtain images from multiple viewpoints requires
more time and exposure of the patient to contrast and x-rays. The
nature of the image as a "lumenogram," along with limited spatial
resolution, make it difficult, if not impossible, to make any
statement about the characteristics of the tissue in the vessel
wall. For example, it is impossible to distinguish between a
fibrotic plaque and one with a necrotic, lipid filled core.
[0006] Intravascular ultrasound (IVUS) has emerged, in the last 15
years, as an imaging technology to measure tissue structural
characteristics, in particular for blood vessels. IVUS employs a
specially designed catheter, with an acoustic transducer at the
distal tip, to send and receive ultrasonic signals. So called,
"mechanical" IVUS catheters consist of a flexible polymer outer
sheath, inside of which is a core that rotates and pulls back
through the vessel, generating a series of circumferential scans of
the vessel wall. The core typically consists of an RF transmission
line, connecting the transducer at the distal tip to drive and
receive electronics. A helically wound wire cable is typically used
to transmit torque from a rotary motor, through the core to the
distal tip, to ensure rotation of the tip with consistent angular
velocity. Ultrasonic waves are back scattered by human tissue. The
strength of the back scatter is a function of tissue properties,
including density. The signal returning from tissue from a rotating
IVUS catheter can be represented as a radar plot with a 360 degree
view of a section of the vessel and the radial dimension showing
the strength of the signal return as a function of distance from
the center of the catheter. An advantage of IVUS is that it allows
one to obtain an image of the inner walls of the vessel, even
through intervening blood. With axial image resolution of 100-200
microns and imaging depth of greater than 5 mm, various structures
within the vessel wall can be visualized, including areas of
calcification and thickening of the arterial wall. Also, the
boundary between the lumen and the vessel intima as well as that
between the media and the adventitia can be visualized with
accuracy good enough to calculate lumen dimensions and the area of
plaques, or "plaque burden."
[0007] Optical coherence tomography (OCT) is an emerging technology
that also provides structural information similar to IVUS. OCT
depends on the scattering of light by tissue and uses the coherence
properties of light, for example, using a Michelson interferometer,
to determine the distance at which a scattering event occurred. The
technique is similar to IVUS in that a catheter is moved over a
guidewire into the blood vessel to a region of interest and then
the core of the catheter is pulled back to scan the artery.
However, there are several key differences. For example, the OCT
signal cannot penetrate blood, requiring that the blood be cleared
from the area of the vessel being imaged. A variety of methods have
been employed to accomplish this, the most promising and least
dangerous to the patient being a non-occlusive flush, using a bolus
of saline/contrast mix. This method provides several seconds in
which to obtain an image of a vessel segment.
[0008] Another class of intravascular analysis systems uses
chemical analysis modalities. These approaches generally rely on
optical spectral analysis including near infrared (NIR), Raman, and
fluorescence spectral analysis.
[0009] Near Infrared Spectroscopy (NIR or NIRS) is a technique,
again using light in the near infrared region of the spectrum,
intended not to image the physical structure of the artery, but the
chemical constituents, specifically cholesterol, of the arterial
wall. Unlike OCT, NIR can perform such measurement through blood.
Operation of a NIR catheter is very similar to that of IVUS with
regard to insertion into the patient and pullback and acquisition
of data. The result is a two dimensional map of the cholesterol, or
lipid, content of the artery.
[0010] NIRS utilizes an intravascular optical catheter which,
similarly to IVUS, is driven by a pullback and rotation unit that
simultaneously rotates the catheter head around its longitudinal
axis while withdrawing the catheter head through the region of the
blood vessel of interest.
[0011] During this pullback operation, the spectral response of the
inner vessel walls is acquired in a raster scan operation. This
provides a spatially-resolved spectroscopic analysis of the region
of interest. The strategy is that by determining the spectroscopic
response of blood vessel walls, the chemical constituents of those
blood vessel walls can be determined by application of chemometric
analysis, for example.
[0012] In Raman spectral analysis, the inner walls of the blood
vessel are illuminated by a narrow band, such as laser, signal. The
Raman spectral response is then detected. This response is
generated by the inelastic collisions betweens photons and the
chemical constituents in the blood vessel walls. This similarly
produces chemical information for the vessel walls.
[0013] Hybrid IVUS/optical catheters have been proposed. For
example, in U.S. Pat. No. 6,949,072, which in incorporated herein
by this reference in its entirety, a "device for vulnerable plaque
detection" is disclosed. Specifically, this patent is directed to
intravascular probe that includes optical waveguides and ports for
the near infrared analysis of the blood vessel walls while
simultaneously including an ultrasound transducer in the probe in
order to enable IVUS analysis of the blood vessel walls.
SUMMARY
[0014] Aspects of the invention relate to systems, methods, and
apparatus for combining three or more intravascular analysis
modalities--and thereby exploiting the different diagnostic
information available from each modality--in a single intravascular
procedure.
[0015] Thus, the present invention concerns multimodal
intravascular analysis. In one embodiment, a single catheter
combines multiple diagnostic modalities, such as 3, 4 or even 5
diagnostic modalities. In some examples, two or more of the
diagnostic modalities are used simultaneously, even during the same
pullback and rotation cycle. In other examples, the modalities are
employed serially in separate pullback and rotation cycles.
[0016] In general, providing catheter systems that yield chemical
information, such as from NIR, Raman, and/or fluorescence
spectroscopic analysis, along with other information: lumen
dimension (stenosis) and vessel dimension (positive remodeling) and
cap thickness (a possible indicator of plaque vulnerability) from
IVUS and OCT and fractional flow rate (FFR) from a flow wire, has
the potential to increase the likelihood of a positive patient
outcome.
[0017] For example, a catheter that combines NIR, IVUS, OCT and a
flow wire, provides the physician with a much more comprehensive
data set from which to formulate a therapy decision, including
stenting, medical therapy, or referral to coronary artery bypass
grafting (CABG).
[0018] A further consideration is the "fusing" of image data
obtained from different modalities (e.g. angiography, NIR, OCT,
IVUS) and the accurate spatial co-registration (longitudinal and
rotational) of the images. Having one catheter that incorporates
multiple invasive imaging modalities provides a fixed frame of
reference that greatly facilitates co-registration, especially when
the diagnostic modalities are employed during the same pullback and
rotation cycle. Success here is further facilitated by including
position detection capabilities in the catheter such as sensors
that detect externally-generated signals, magnetic fields, or
emitters that generate externally detected signals.
[0019] These and other features, aspects, and advantages of the
present invention will become apparent to those skilled in the art
after considering the following detailed description, appended
claims and accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] In the accompanying drawings, reference characters refer to
the same parts throughout the different views. The drawings are not
necessarily to scale; emphasis has instead been placed upon
illustrating the principles of the invention. Of the drawings:
[0021] FIG. 1 is a cross-sectional view of an intravascular probe
with a guidewire in a distal end of a catheter;
[0022] FIG. 2 is a schematic diagram illustrating the use of the
catheter system and a system controller, according to the
invention; and
[0023] FIGS. 3-7 are schematic diagrams illustrating embodiments
1-5 having different component layouts between the pullback and
rotation unit 105 and a console 106.
DETAILED DESCRIPTION
[0024] While IVUS analysis provides valuable information regarding
certain structural aspects of an arterial wall that enables the
practitioner to identify gross structural abnormalities, such as
stenosis and other forms of remodeling, IVUS suffers from a number
of inherent limitations relevant to the objective of characterizing
plaque composition. For this reason, efforts to extend the
capability of IVUS to actual characterization of tissue type (e.g.
calcific, fibrotic, necrotic) in an effort to differentiate types
of plaques and better inform treatment have been largely
unsuccessful. Among the inherent limitations of IVUS that limit its
efficacy are that calcified regions block the propagation of IVUS
radiation. It is not uncommon for a coronary plaque to be covered
with a calcific cap, and therefore, such plaque may go undetected
in an IVUS analysis. Also, softer plaques, which often contain
lipids, are generally hypoechoic. Thus, it is from an absence of
signal that one must infer the plaque composition. Use of a null
signal to infer plaque properties is not ideal and can be subject
to errors.
[0025] OCT, like IVUS, provides information regarding the
structural aspects of the arterial wall but has the capability to
generate images with up to ten times better resolution than IVUS.
This now enables the visualization of structures which cannot be
seen with IVUS. In particular, the thickness of the fibrous cap
covering a plaque with a necrotic core can now be measured with
high precision. However, OCT optical signals are severely
attenuated by blood and also have limited penetration in tissue.
Not only does this mean that it is necessary to clear blood from
the vessel, as mentioned previously, but the imaging depth in
tissue achievable with OCT is limited to approximately 1 mm.
[0026] NIRS, as described above, provides information regarding the
chemical constitution of the artery to identify the, cholesterol,
or lipids content of the artery.
[0027] The inventors have determined that the combination of at
least these three diagnostic modalities can significantly enhance
the efficacy of the intraluminal analysis. For example, by
identifying a variety of arterial abnormalities, such as positive
remodeling (best detectable by IVUS), thin caps (best detectable by
OCT), and a necrotic core (best detectable by spectroscopy, e.g.,
NIR), the diagnostic accuracy can be significantly improved.
Moreover, by combining at least these three modalities in a single
system, apparatus, and method, these multiple informational
components used in the diagnosis can be obtained in a single
intravascular procedure.
[0028] FIG. 1 shows an embodiment of an intravascular catheter
system 100 that combines multiple diagnostic modalities.
[0029] In typical operation, the intravascular catheter 100 is
advanced into a blood vessel 18 using a guidewire 108 that is
threaded through the guidewire lumen 110.
[0030] The catheter system 100 further comprises an inner scanning
catheter core 116 and outer sheath 114. The combination of the
scanning catheter core 116 and sheath 114 enables the inner
scanning catheter core 116 and specifically the catheter tip 112 to
perform longitudinal translation (arrow 50) and rotation (arrow 52)
while the sheath 114 prevents this movement from damaging the
vessel 18 and specifically walls 104.
[0031] The tip 112 of the scanning catheter core 116 is located at
the distal end of the catheter 100 and includes an optical bench
118 to transmit and receive light, typically infrared light, and an
ultrasound transducer system 120 to transmit and receive ultrasound
energy.
[0032] At least the distal end of the sheath 114 is composed of
materials that are transparent to light, e.g., near infrared,
employed by the optical diagnostic modalities (e.g., a polymer) and
will also propagate ultrasound used by IVUS.
[0033] The optical bench 118 contains the terminations 122t, 123t
of at least one delivery fiber 122 and at least one collection
fiber 123, which extend between the proximal and distal ends of the
catheter 100. Light 125 propagating through and emitted from the
termination 122t of the delivery fiber 122 is redirected by a
delivery mirror 124 towards the vessel, e.g., arterial, wall 104. A
collection mirror 126 redirects light 127 scattered or reflected
from various depths of the arterial wall 104 into a distal end 123t
of the collection fiber 123.
[0034] In one implementation, a focusing element serves to collect
the diverging optical beam from optical fiber 122 and refocus the
beam into the vessel wall. Suitable focusing elements may include a
gradient indexed lens, micro-optical lens, a grating or a curved
mirror.
[0035] In an alternate implementation, a single fiber or fiber
bundle may function as both a delivery and a collection
waveguide.
[0036] In one implementation, the at least one delivery fiber 122
is a single mode optical fiber that propagates only a single
spatial mode within the fiber at the wavelengths of interest. The
collection fiber 123 is multimode fiber having a core diameter of
approximately 60 micrometers or larger, including diameters to
about 200 micrometers or larger. In one embodiment, the single mode
delivery fiber is used with light generated by a tunable laser. In
this embodiment, the delivery fiber is used to couple light both to
the vessel walls 104 and back to the interferometer for OCT
analysis. The large core of the collection fiber and higher
numerical aperture improves collection efficiency for NIR, Raman,
and/or fluorescence spectroscopic analysis. In an alternate
implementation, other suitable sources of optical radiation, such
as a super luminescent light-emitting diode ("SLED"), may be used
instead of or in addition to the tunable laser.
[0037] The ultrasound transducer system 120 includes one or more
transducers that direct ultrasound energy 130 towards the arterial
wall 104 and receive ultrasound energy 132 reflected from the
arterial wall 104. In one embodiment, the ultrasound transducer
system is longitudinally adjacent to the optical bench 118. In an
alternate implementation, the ultrasound system may be located at
substantially the same longitudinal position as the distal end(s)
of the delivering and collection fiber(s), offset from the
fiber(s), for example, by 180 degrees. Using time multiplexing in
one implementation, a single ultrasound transducer both generates
the transmitted energy 130 and received reflected energy 132 into
an electrical signal carried on wires 128. For example, during a
first time interval, an electrical signal carried on wires 128
actuates the ultrasound transducer 120 to emit a corresponding
ultrasound signal 130. Then during a second time interval, after
the ultrasound signal 130 has reflected from the arterial wall 104,
the ultrasound transducer 120 produces an electrical signal carried
on wires 128. This electrical signal corresponds to the received
ultrasound signal 132.
[0038] The received signal 132 is used by this IVUS analysis
modality to determine the distance D(wall) between the head or
distal end of the scanning catheter 112 and the vessel wall 104 and
to determine the physical morphology, or structure, of the vessel
wall itself. For example, the received signal 132 may be useful for
characterizing atherosclerotic plaques, including plaque volume in
the blood vessel wall and also the degree of stenosis of the blood
vessels.
[0039] In other embodiments, the ultrasound signal is generated
photo-acoustically by sending a light pulse through optical fiber
122 with enough energy to create an acoustic event that is detected
by the ultrasound transducer system 120.
[0040] Between the sheath 114 and the core 116 is a transmission
medium 134, such as saline or other fluid, surrounding the
ultrasound transducer system 120 to facilitate acoustic
transmission. The transmission medium 134 is also selected to be
transparent to the near infrared light emitted from and received by
the optical bench 118.
[0041] A torque cable 136 is attached to a scanning catheter core
116 and surrounds the optical fibers 122, 123 and the wires 128.
This torque cable 136 transmits the torque from a pullback and
rotation system through to the scanning catheter head 112. This
feature enables the scanning catheter head 112 to rotate within
sheath 114 to circumferentially scan the arterial wall 104 with
light 125 and ultrasound energy 130.
[0042] In one embodiment, the catheter head 112 comprises an
internal element 150 of a position detection system. The internal
element 150 communicates with an external element 152, typically
outside the patient's body, in order to determine the position of
the catheter tip 112 relative to the external element 152. In one
embodiment, the internal element is a sensor that detects a field,
e.g., magnetic, generated by the external element 152. The detected
position information is transmitted on wires 128 and is received by
controller 300, as shown in FIG. 2.
[0043] In one embodiment, a position detection system developed by
Mediguide Ltd. for guidewires and coronary catheterization devices
could be used. The technology provides realtime position
information. It uses a small sensor located in the device that is
able to determine its position within a magnetic field created
around the patient. In this way, additional position information is
available, beyond that which would typically be provided from X-ray
angiogram images.
[0044] FIG. 2 illustrates an exemplary system for supporting
multiple diagnostic catheter functions.
[0045] The system generally comprises the catheter 100, a
controller 300, and a user interface 320.
[0046] In operation, first the guide wire and then the catheter 100
are inserted into the patient 2 via a guide catheter (not shown)
already placed in a peripheral vessel, such as the femoral artery
10. The catheter tip 112 is then moved to a desired target region,
such as a coronary artery 18 of the heart 16 or the carotid artery
14. This is achieved by moving the catheter 100 up through the
aorta 12, riding on the guidewire 108.
[0047] When at the desired site, the pullback and rotation unit 105
is used both for the mechanical drive to the scanning catheter 112
and also to couple optical and electrical signals to and from the
catheter 100. Specifically, the pullback and rotation unit 105
drives the scanning catheter core 116 to rotate and withdraw
through the outer sheath 114. An exemplary pullback and rotation
unit is disclosed in U.S. pat. appl. Ser. No. 11/875,590, filed on
Oct. 19, 2007, entitled Optical Catheter Carriage Interlock System
and Method (U.S. Patent Application Pub. No. 2008-0097223), which
is incorporated herein by this reference in its entirety. This
disclosed pullback and rotation unit shows an optical layout in
which the tunable signal from a tunable laser is coupled onto a
rotating and translating drum via a rotary fiber optical joint
(FORJ). Returning NIR signals are detected on the drum. Additional
detectors are provided for common mode rejection of noise generated
in the FORJ.
[0048] The IVUS subsystem 312 and the optical subsystem 310 are
activated during each pullback cycle to generate appropriate
signals for transmission through the catheter 100 and receive,
detect, preprocess and digitize signals returned from the vessel
walls 104. In a preferred embodiment, a tunable laser--or other
suitable source of optical radiation--in the optical subsystem
generates a narrowband optical signal that is wavelength scanned
over a range in the NIR, covering one or more spectral bands of
interest. The same or a different laser--or other suitable source
of optical radiation--is used to generate signals for OCT analysis
of the vessel walls. At the same time, the IVUS subsystem 312 is
enabled to simultaneously generate ultrasound images of the vessel
walls 104.
[0049] In one embodiment, the returning light is transmitted back
down multimode collection fiber 123 of the catheter 100. The
returning radiation is provided to the optical subsystem 310, which
can comprise one or multiple optical detectors or spectrometers.
Light returning on delivery fiber 122 is also analyzed, for example
in an interferometer, in order to perform OCT analysis.
[0050] The optical analysis subsystem 310 collects, preprocesses,
digitizes and passes raw spectral and OCT to the computer 117 for
further processing, analysis and display information to the user
interface 320.
[0051] The IVUS subsystem 312 collects, preprocesses, digitizes and
passes the information from the ultrasound transducer 120 to the
computer 117 for further processing, analysis and display formation
to the user interface 320.
[0052] In more detail, the IVUS subsystem 312 comprises the drive
electronics for driving the ultrasound transducer 120 and analyzing
the response of the transducer 120 to determine the structural
measure of interest in an IVUS-type system.
[0053] Generally, the computer 117 receives preprocessed, digitized
raw IVUS, OCT and NIR data, performs additional processing, scan
conversion and data registration and presents one or more
representations of the morphological and chemical structure of the
vessel walls to the operator via interface 320, as images and/or
data maps. The computer 117 may combine the structural analysis
information from the IVUS subsystem 312 with information from the
optical analysis subsystem 310. For example, information from both
systems is combined into hybrid images displayed to the operator on
user interface 320. In further examples, the information from the
IVUS and/or OCT analysis is used to improve the NIR analysis as
described in U.S. appl. Ser. No. 12/062,188, filed Apr. 3, 2008,
entitled: System and Method for Intravascular Structural Analysis
Compensation of Chemical Analysis Modality, which is incorporated
herein by this reference in its entirety. The collected spectral
response may be used to determine whether each region of interest
of the blood vessel wall 104 comprises a lipid pool or lipid-rich
atheroma, a disrupted plaque, a vulnerable plaque or thin-cap
fibroatheroma (TCFA), a fibrotic lesion, a calcific lesion, and/or
normal tissue as described in U.S. Pat. Publ. Nos. US
2004/0024298-A1 and US-2005/0228295-A1, which are incorporated
herein by this reference in their entirety.
[0054] FIGS. 3-7 illustrate different embodiments of the pullback
and rotation unit 105 and a console 106 and how components of the
optical subsystem 310, IVUS subsystem 312, and computer 117 are
distributed between the pullback and rotation unit 105 and console
106.
[0055] FIG. 3 illustrates embodiment 1. Like the other embodiments
discussed below, the proximal portion of the catheter 100 connects
or interfaces with the pullback and rotation unit 105.
Specifically, the sheath 114 connects to the stationary housing 410
of the unit 105. The core 116 connects to a drum unit 408 that
drives the rotation of the core 116, see arrow 412, and the
longitudinal movement of the core 116 relative to the sheath 114,
see arrow 414.
[0056] The drum 408 includes a slip ring/FORJ assembly 420 that
couples electrical and optical signals between the rotating drum
408 and the stationary components of the console 106. The slip
rings support the electrical connections and the FORT supports one
or more optical connects across the rotating interface. In more
detail, control and communication electrical connections 422 are
provided between computer 117 and the drum, along with data
connections 424. Optical connections 426 are provided between the
drum 408 and an NIR/OCT source and interferometer unit 428 of the
optical subsystem 310. Finally, power is provided to the drum 408
by a D.C. power supply 430 on connection 432.
[0057] The computer 117 also controls the NIR/OCT source and
interferometer unit 428 of the console. The power supply 430 powers
the NIR/OCT source and interferometer unit 428 and the computer
117.
[0058] In embodiment 1, the components supporting the OCT analysis
are provided in the NIR/OCT source and interferometer unit 428 of
the console 106. This includes a tunable laser that tunes the scan
band for the NIR analysis. The light returning on the collection
fiber 123 of the catheter 100 is detected on a detector 442 of the
optical subsystem 310 on drum 408. The electrical components of the
IVUS system are similarly located on the drum 408, including the
transceiver electronics 440 of the IVUS subsystem 312. The data
generated by the IVUS analysis and the NIR analysis is transmitted
electrically to the computer via the slip rings on connection
424.
[0059] The FORJ 420 connects the delivery fiber 122 of the catheter
100 to the OCT source and interferometer 428, which includes
reference arm, a tunable laser, coupler/beamsplitter and an OCT
detector such as a balanced detection system.
[0060] In the operation of embodiment 1, optical radiation in the
near infrared (NIR) spectral regions is used for both the OCT and
NIR analysis, being generated by the tunable laser of unit 428.
Exemplary scan bands include 1000 to 1450 nanometers (nm)
generally, or 1000 nm to 1350 nm, 1150 nm to 1250 nm, 1175 nm to
1280 nm, and 1190 nm to 1250 nm, more specifically. Other exemplary
scan bands include 1660 nm to 1740 nm, and 1630 nm to 1800 nm.
[0061] FIG. 4 shows embodiment 2, which differs from embodiment 1
in a number of respects. Specifically, in this embodiment, the IVUS
transceiver 440 of the IVUS subsystem 312 is located on the console
106. Thus the slip ring electrical connections must support the
transmission of radio frequency signals on connection 450 between
the transceiver 440 and the drum 408. As a result, this embodiment
would be compatible with the pullback and rotation unit described
in incorporated application Ser. No. 12/062,188, with minor
modifications to support the RF connections for the IVUS
subsystem.
[0062] FIG. 5 shows embodiment 3, which differs from embodiment 1
in a number of respects. In this embodiment, the NIR/OCT source and
interferometer unit 428 utilizes a broadband source, instead of the
tunable laser embodiment 1. In a preferred embodiment, the source
is a superluminescent light emitting diode (SLED).
[0063] Thus, to resolve the NIR spectral response of the vessels, a
spectrometer spectrograph/detector system 460 is provided, in the
console 106, in this example. This configuration of the optical
subsystem 310 requires a two optical channel FORJ 420, channel 426
associated with the delivery fiber 122 and channel 462 associated
with the collection optical fiber 123. Such dual channel FORJ
components are offered, for example, by Princetel, Inc. (product
number MS2-155-28).
[0064] The spectrograph 460 is preferably a high speed device to
support high speed scanning of the vessel walls at about 300
frames/second, simultaneously with the OCT analysis, in some
implementations. In one embodiment, an InGaAs detector array from
Hamamatsu Photonics K.K. is used in combination with a Horiba Jobin
Yvon Inc. grating, which disperses the spectrum over the detector
array.
[0065] FIG. 6 shows embodiment 4 which differs from embodiment 3 in
that the OCT source is not used for the NIR analysis. Specifically,
in this example, an NIR SLED optical source 470 in provided on the
drum 408. Light from the NIR source is combined with OCT light from
the OCT source and interferometer unit 428 on a single delivery
fiber, in one example, or two delivery fibers are provided in the
catheter 100, in another example. Light returning on the collection
fiber 123 is coupled off the drum 408 through a dual channel FORJ
420 to spectrograph 460. This system has advantages in that the
source for the OCT and NIR can be individually optimized for each
analysis, possibly operating at different wavelength scan speeds
and in different scan bands.
[0066] FIG. 7 shows embodiment 5, which is similar to embodiment 4,
but includes the capability for Raman and/or fluorescence analysis.
Specifically, it includes a Raman and fluorescence excitation
source 482. The Raman/fluorescence laser source 482 is a relatively
high power laser and is usually a single frequency laser or laser
with only limited wavelength scanning. The Raman process is a weak
and non-linear process. Thus, high excitation powers are preferably
used, but below the damage threshold for the tissue of the vessel
walls 104.
[0067] The light from this Raman source 482 is selectively coupled
onto the delivery fiber via optical switch 480. In other examples,
a wavelength multiplexer is used in place of the switch 482 when
the optical bands of the OCT and NIR systems 428 do not overlap
with the wavelength band of the light from the excitation source
482. Thus this embodiment adds Raman and/or fluorescence analysis
to NIR and OCT modalities.
[0068] Serial/Simultaneous NIR/OCT/IVUS Scanning
[0069] Depending on the implementation, the IVUS information and
the optical analysis information are produced during the same or
different scans of the scanning catheter 112. For example, in one
implementation, the optical information 410 produced by the NIR and
OCT analysis, and IVUS information produced by the IVUS analysis,
are captured simultaneously while withdrawing and rotating the
scanning catheter 112 through the blood vessels 104, in the same
pullback cycle of the pullback and rotation unit 105. In other
implementations, the optical information 410 produced by the NIR
analysis and IVUS information produced by the IVUS subsystem are
captured during the same pullback and rotation operations of the
scanning catheter 112 but the OCT analysis is performed in its own
dedicated pullback cycle. Then the optical information data set
produced by the NIR analysis and IVUS data set are spatially
aligned with the OCT data set, with respect to each other. This
alignment further includes compensation for the offset distance
D(offset) between the IVUS transducer 120 and the optical bench
118, see FIG. 1.
[0070] In a serial scan implementation protocol, the NIR analysis
is first performed over the entire length of the artery of
interest. This leverages an advantage of the NIR analysis: neither
occlusion nor a saline flush is necessary since the analysis can be
performed through the flowing blood. This initial NIR analysis is
used to identify regions of the artery that require further
analysis via OCT. Another advantage associated with serial scanning
arises from the fact that the OCT analysis is typically performed
at higher scanning speeds in terms of the rotation speed of the
catheter and the rate of pullback through the artery. Thus when NIR
and OCT are performed during separate scans, optimal speeds can be
used for both modalities. Another advantage is that the OCT is
performed only at selected locations and thus the length of time
and volume of the concomitant saline flush is minimized and kept
within clinically appropriate limits.
[0071] Also, any IVUS scan typically takes longer than the OCT scan
since it uses slower rotation speeds and pullback speeds than the
OCT. Generally, the OCT scan is completed with about 4-5 seconds,
which is the window provided by a 20 cc saline flush.
[0072] Despite the fact that some implementations employ separate
scans for the NIR, OCT and IVUS analyses, the disclosed system
provides advantages in that only a single catheter must be inserted
in the patient, decreasing risk to the patient and lowering the
time required for the invasive portions of the procedure.
[0073] A final key consideration in the "fusing" of image data
obtained from different modalities (e.g. angiography, NIR, OCT,
IVUS) is the accurate spatial co-registration (longitudinal and
rotational) of the images. Having one catheter that incorporates
multiple invasive imaging modalities provides a fixed frame of
reference that greatly facilitates co-registration. This
registration is further improved by using the position detection
system including the internal element 150 and external element
152.
[0074] Thus, exemplary embodiments have been fully described above
with reference to the drawing figures. Although the invention has
been described based upon these exemplary embodiments, it would be
apparent to those of skill in the art that certain modifications,
variations, and alternative constructions could be made to the
described embodiments within the spirit and scope of the
invention.
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