U.S. patent application number 13/968993 was filed with the patent office on 2013-12-19 for cardiovascular imaging system.
This patent application is currently assigned to The Spectranetics Corporation. The applicant listed for this patent is The Spectranetics Corporation. Invention is credited to Wade Bowe, Ken Harlan, Chris J. Hebert, Jacob Keeler, James Nye, Robert Splinter, Kevin D. Taylor.
Application Number | 20130338500 13/968993 |
Document ID | / |
Family ID | 43428003 |
Filed Date | 2013-12-19 |
United States Patent
Application |
20130338500 |
Kind Code |
A1 |
Taylor; Kevin D. ; et
al. |
December 19, 2013 |
CARDIOVASCULAR IMAGING SYSTEM
Abstract
Embodiments of the present invention include a laser catheter
that includes a catheter body, a light guide, and a distal tip that
extends beyond the exit aperture of the light guide. In some
embodiments, an imaging device is disposed on the distal tip such
that the imaging device is distal relative to the exit aperture of
the light guide. In some embodiments, the imaging device can be
gated to record images during and/or slightly beyond periods when
the laser catheter is not activated.
Inventors: |
Taylor; Kevin D.; (Colorado
Springs, CO) ; Harlan; Ken; (Colorado Springs,
CO) ; Nye; James; (Colorado Springs, CO) ;
Splinter; Robert; (Colorado Springs, CO) ; Keeler;
Jacob; (Colorado Springs, CO) ; Hebert; Chris J.;
(Colorado Springs, CO) ; Bowe; Wade; (Colorado
Springs, CO) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
The Spectranetics Corporation |
Colorado Springs |
CO |
US |
|
|
Assignee: |
The Spectranetics
Corporation
Colorado Springs
CO
|
Family ID: |
43428003 |
Appl. No.: |
13/968993 |
Filed: |
August 16, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12649759 |
Dec 30, 2009 |
8545488 |
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13968993 |
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12337232 |
Dec 17, 2008 |
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12649759 |
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11228845 |
Sep 16, 2005 |
7572254 |
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12337232 |
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60611191 |
Sep 17, 2004 |
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Current U.S.
Class: |
600/439 |
Current CPC
Class: |
A61B 8/12 20130101; A61B
2090/3782 20160201; A61B 2017/22038 20130101; A61B 2018/2238
20130101; A61B 18/245 20130101; A61B 2017/22061 20130101 |
Class at
Publication: |
600/439 |
International
Class: |
A61B 8/12 20060101
A61B008/12; A61B 18/24 20060101 A61B018/24 |
Claims
1-19. (canceled)
20. A method comprising: positioning a laser catheter within a
vessel, wherein the laser catheter includes a fiber optic bundle
with an exit aperture; imaging the interior of the vessel near the
distal tip of the laser catheter using an imaging device disposed
at the distal end of the laser catheter relative to an exit
aperture of the fiber optic bundle, wherein the imaging device
provides images of the interior of the vessel; activating the laser
catheter to ablate material within the vessel; and gating the
imaging device while the laser catheter is activated.
21. The method according to claim 20, wherein the gating includes
disabling the imaging device.
22. The method according to claim 20, wherein the gating includes
deleting images recorded while the laser catheter is activated.
23. The method according to claim 20, wherein the gating includes
not providing images to a display while the laser catheter is
activated.
24. The method according to claim 20, wherein the imaging device is
an ultrasound imaging device.
25. The method according to claim 24, wherein the ultrasound
imaging device comprises a probe.
26. The method according to claim 20, wherein the imaging device is
disposed at least 0.9 cm from the exit aperture of the fiber optic
bundle.
27. The method according to claim 20, wherein the laser catheter
further includes a tip extending distally of from the distal end of
the catheter body.
28. The method according to claim 27, wherein imaging device is
disposed on the tip.
29. The method according to claim 27, wherein the tip is disposed
eccentrically to the light guide.
30. The method according to claim 29, wherein imaging device is
disposed on the tip.
31. The method according to claim 27, wherein the laser catheter
further includes a catheter body and the fiber optic bundle is
longitudinally moveable relative to the catheter body.
32. The method according to claim 31, wherein the laser catheter
further includes a ramp disposed on the tip, wherein the exit
aperture of the fiber optic bundle is slidably moveable relative to
the ramp.
33. The method according to claim 20, wherein the laser catheter
further includes a catheter body.
34. The method according to claim 33, wherein the fiber optic
bundle is arranged concentrically about the central axis of the
catheter body.
35. The method according to claim 33, wherein the fiber optic
bundle is arranged eccentrically about the central axis of the
catheter body.
36. The method according to claim 33, wherein the catheter body
further includes a guide wire lumen.
37. The method according to claim 36, wherein guide wire lumen
extends through the catheter body.
38. The method according to claim 37, wherein the laser catheter
further includes a tip extending distally of from the distal end of
the catheter body.
39. The method according to claim 38, wherein guide wire lumen
extends through the tip.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This application is a continuation in part of U.S.
Non-Provisional application Ser. No. 12/337,232 filed on Dec. 17,
2008, which is a continuation in part of U.S. Non-Provisional
application Ser. No. 11/228,845 filed on Sep. 16, 2006, which
claims the benefit of U.S. Provisional Application Ser. No.
60/611,191 filed Sep. 17, 2004. Each of these disclosures are
incorporated by reference in their entirety.
BACKGROUND
[0002] Arteries are the primary blood vessels that are responsible
for providing blood and oxygen to the heart muscle. Arterial
disease occurs when arteries become narrowed or blocked by a
buildup of plaque (as some examples, atherosclerotic plaque or
other deposits). When the blockage is severe, the flow of blood and
oxygen to the heart muscle is reduced, causing chest pain. Arterial
blockage by clots formed in a human body may be relieved in a
number of traditional ways. Drug therapy, including nitrates,
beta-blockers, and peripheral vasodilatator drugs to dilate the
arteries or thrombolytic drugs to dissolve the clot, can be
effective. If drug treatment fails, angioplasty may be used to
reform or remove the atherosclerotic plaque or other deposits in
the artery.
[0003] Traditional balloon angioplasty is sometimes used to address
the blockage by inserting a narrow, flexible tube having a balloon
into an artery in the arm or leg. The blocked area in the artery
can be stretched apart by passing the balloon to the desired
treatment site and gently inflating it a certain degree. In the
event drug therapy is ineffective or angioplasty is ineffective or
too risky (often introduction of a balloon in an occluded artery
can cause portions of the atherosclerotic material to become
dislodged, which may cause a total blockage at a point downstream
of the subject occlusion, thereby requiring emergency procedures),
the procedure known as excimer laser angioplasty may be
indicated.
[0004] Excimer laser angioplasty procedure is similar in some
respects to conventional coronary balloon angioplasty. A narrow,
flexible tube, the laser catheter, is inserted into an artery in
the arm or leg. The laser catheter contains one or more optical
fibers, which can transmit laser energy. The laser catheter is then
advanced inside the artery to the targeted obstruction at the
desired treatment site. After the laser catheter has been
positioned, the laser is energized to "remove" the obstruction.
[0005] In many procedures, the lesion is often engaged similar to
conventional balloon angioplasty by crossing the blockage with a
guidewire. The laser catheter's thin, flexible optical fibers
facilitate the desired positioning and alignment of the catheter.
Using the excimer laser, the clinician performs a controlled
blockage removal by sending bursts of ultraviolet light through the
catheter and against the blockage, a process called "ablation." The
catheter is then slowly advanced through the blockage reopening the
artery. If there are multiple blockages, the catheter is advanced
to the next blockage site and the above step is repeated. When the
indicated blockages appear to be cleared, the catheter is
withdrawn.
[0006] Due to the configuration of the optical fibers in most prior
art laser catheters, the clinician is able to ablate only material
that is typically directly in front of the distal end of the
catheter. Thus, the debulked tissue area is limited to an area
approximately the size of the optical fiber area at the distal end
of the catheter. Typically, follow-up balloon angioplasty is
recommended.
[0007] Imaging during atherectomy or angioplasty procedures often
uses fluoroscopy imaging techniques for targeting and ablation of
blockages. Fluoroscopy, however, has limitations. For example, does
not allow a doctor or technician to visualize plaque or vessel
walls.
BRIEF SUMMARY
[0008] Embodiments of the invention are directed toward laser
catheters. In one embodiment, a laser catheter can include a
catheter body, a light guide, a distal tip, and an imaging device
disposed distal relative to the exit aperture of the light guide.
The catheter body, for example may include a central axis, a
proximal end and a distal end. The catheter body may also include a
lumen disposed between the proximal end and the distal end, the
lumen having an opening at the distal end. The light guide may also
include a proximal end and a distal end. In some embodiments, the
light guide may also include at least one fiber optic and may at
least partially be disposed within the lumen and/or movable
therein. The distal tip may be positioned at the periphery of the
catheter body and may extend from the distal end of the catheter
body. The imaging device can be disposed on the distal tip, for
example, at a position distal from the exit aperture of the light
guide. The distal tip may also include a guidewire lumen that
includes a guidewire port at the distal end of the distal tip. A
retaining wire may also be used in some embodiments and can be
coupled with the distal tip and slidably coupled with the light
guide. A balloon, for example, may be positioned between the
opening at the first distal end of the catheter body and the distal
tip.
[0009] Some embodiments of the invention can also include a balloon
catheter. The balloon catheter can include a catheter body, for
example may include a central axis, a proximal end and a distal
end. The catheter body may also include a lumen disposed between
the proximal end and the distal end, the lumen having an opening at
the distal end. The balloon catheter can also include a light guide
that may also include a proximal end and a distal end. In some
embodiments, the light guide may also include at least one fiber
optic and may at least partially be disposed within the lumen
and/or movable therein. The balloon can be disposed at the radial
exterior of the catheter body. In use, for example, the balloon can
be inflated such that the balloon makes contact with a vessel wall.
Contact with the vessel wall can move the distal tip of the
catheter away from vessel wall toward an opposing vessel wall.
[0010] Some embodiments of the invention can also include an
imaging catheter that gates imaging during ablation. For example,
an imaging catheter can include a light guide coupled with a laser
and an imaging device disposed distally relative to the light guide
exit aperture.
[0011] During operation, in some embodiments, images from the light
guide can be filtered and/or gated while the laser is activated. In
other embodiments, the imaging device can be deactivated during
ablation.
[0012] The following detailed description, together with the
accompanying drawings, will provide a better understanding of the
nature and advantage of the embodiments disclosed herein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 shows a laser catheter system according to one
embodiment.
[0014] FIGS. 2A and 2B show examples of laser catheters with a
distal imaging device according to some embodiments of the
invention.
[0015] FIG. 3A shows a side view of a laser catheter according to
one embodiment of the invention.
[0016] FIG. 3B shows a side view of a balloon laser catheter
according to one embodiment of the invention.
[0017] FIG. 4A shows a cross section of the catheter in FIG. 3A
along line A-A.
[0018] FIG. 4B shows a cross section of the catheter in FIG. 3A
along line B-B.
[0019] FIG. 4C shows a cross section of the catheter in FIG. 3A
along line C-C.
[0020] FIG. 4D shows a cross section of the catheter in FIG. 3A
along line D-D.
[0021] FIG. 4E shows a cross section of the catheter in FIG. 3A
along line E-E.
[0022] FIG. 4F shows a cross section of the catheter in FIG. 3B
along line F-F.
[0023] FIG. 5A shows a side view of a laser catheter with a ramp
according to one embodiment of the invention.
[0024] FIG. 5B shows a side view of an engaged laser catheter with
a ramp according to one embodiment of the invention.
[0025] FIG. 6A shows a cross section of the catheter in FIG. 5A
along line A-A.
[0026] FIG. 6B shows a cross section of the catheter in FIG. 5A
along line B-B.
[0027] FIG. 6C shows a cross section of the catheter in FIG. 5A
along line C-C.
[0028] FIG. 6D shows a cross section of the catheter in FIG. 5A
along line D-D.
[0029] FIG. 6E shows a cross section of the catheter in FIG. 5B
along line E-E.
[0030] FIG. 7A shows a side view of a balloon catheter with the
balloon deflated according to another embodiment of the
invention.
[0031] FIG. 7B shows a side view of a balloon catheter with the
balloon inflated according to another embodiment of the
invention.
[0032] FIG. 8 is a side view of a balloon biasing catheter
according to one embodiment.
[0033] FIGS. 9A, 9B, 10A, and 10B show a cutaway view of a balloon
biasing catheter in use within a vessel according to one
embodiment.
[0034] FIG. 11 is a flowchart describing one embodiment for using a
biasing catheter.
[0035] FIG. 12 is another flowchart describing another embodiment
for using a biasing catheter.
[0036] FIG. 13 is a flowchart describing another embodiment for
using a biasing catheter in conjunction with an imaging device.
DETAILED DESCRIPTION
[0037] Embodiments of the present invention include a laser
catheter that employs an imaging device. In some embodiments, the
imaging device is disposed distal (or forward) relative to the exit
aperture of the laser catheter. In some embodiments, the laser
catheters can employ gating techniques to ensure that laser pulses
don't interfere with imaging. Other embodiments include laser
catheters that include balloons or ramps that can deflect the exit
aperture of the laser catheter.
[0038] FIG. 1 shows a laser catheter system 100 in use according to
one embodiment. A laser 130 is shown coupled with a user interface
180. In this embodiment the user interface 180 is computer
programmed to control the laser 130. The laser, for example, may be
an excimer laser. The laser, for example, may also produce light in
the ultraviolet range. The laser is connected with a catheter 170
that may be inserted into a vessel of the human body 110. The laser
catheter system 100 may employ one or more tapered waveguides that
guide laser light from the laser 130 through the catheter 170
toward a target.
[0039] FIG. 2A shows laser catheter 200 with distal imaging device
260 according to some embodiments. Laser catheter 200 can include a
catheter body 205 (or sheath) within which a fiber optic bundle 210
(or any other light guide) is disposed. Fiber optic bundle can
include any number of optical fibers and, in some embodiments, can
include a separate sheath. Catheter body 205 can include a distal
end and a proximal end. The proximal end of catheter body 205 can
include a coupler that is configured to couple with a laser source
as shown in FIG. 1. The proximal end of the fiber optic bundle can
also be coupled with the coupler in order to receive and conduct
laser light through the optical fibers. The distal end of catheter
body 205 includes opening 207 from which the distal end of fiber
optic bundle 210 extends.
[0040] As shown in FIG. 2A, imaging device 260 is disposed distal
relative to the exit aperture of optical light guide 210 (e.g., a
fiber optic bundle). Light guide 210 can be disposed within sheath
205. In some embodiments, imaging device 260 can be disposed on
eccentric distal tip 213. In other embodiments, imaging device 260
can be disposed on an axially placed distal tip. Distal tip can
also extend In yet other embodiments, imaging device 260 can be
disposed distal relative to the exit aperture of light guide 210 in
any configuration. In some embodiments, imaging device 260 can be
positioned at least 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0 cm
longitudinally (or forward) from the distal end (or exit aperture)
of light guide 210.
[0041] Imaging device 260, for example, can be an ultrasonic device
such as an Intracoronary/Intravascular Ultrasound (ICUS/IVUS)
device, which can employ very small transducers arranged on a
catheter and provides electronic transduced echo signals to an
external imaging system in order to produce a two or
three-dimensional image of the lumen, the arterial tissue, plaque,
blockages, and/or tissue surrounding the artery. These images can
be generated in substantially real time and can provide images of
superior quality to the known x-ray imaging methods and
apparatuses. Other imaging methods and intravascular ultrasound
imaging applications would also benefit from enhanced image
resolution. An ultrasound device, for example, can include a
flexible polyimide film layer.
[0042] Imaging device 260 can be coupled with a number of wires
and/or fiber optics that extend through catheter body 205 toward
the proximal end of catheter 200. For example, for IVUS imaging
devices, seven braided wires can be used. Some or all of these
wires, for example, can have a diameter less than 0.01 inches.
[0043] FIG. 3A shows laser catheter 300 according to another
embodiment of the invention. Laser catheter 300 can include a
catheter body 205 (or sheath) within which a fiber optic bundle 210
(or any other light guide) is disposed. Fiber optic bundle can
include any number of optical fibers and, in some embodiments, can
include a separate sheath. Catheter body 205 can include a distal
end and a proximal end. The proximal end of catheter body 205 can
include a coupler that is configured to couple with a laser source
as shown in FIG. 1. The proximal end of the fiber optic bundle can
also be coupled with the coupler in order to receive and conduct
laser light through the optical fibers. The distal end of catheter
body 205 includes opening 207 from which the distal end of fiber
optic bundle 210 extends. Fiber optic bundle can include a marker
band 211 at the distal tip of the fiber optic bundle that can
include any number of sizes and/or shapes. Marker band 211, for
example, can include a radiopaque material.
[0044] Catheter body 205 can include tip 213, that extends from
opening 207. In some embodiments, tip 213 can be coupled with
catheter body 205. In other embodiments, tip 213 can be integral
with catheter body 205. In some embodiments, tip 213 can support
the distal end of fiber optic bundle 210. Fiber optic bundle 205
can include a guidewire lumen that extends through a portion of the
catheter body. During use guidewire 215 can be positioned within a
vessel, laser catheter 200 can be threaded over guidewire 215 using
the guidewire lumen in order to direct the catheter through a
vessel toward a target. In some embodiments, guidewire lumen can
extend through at least a portion of tip 213. Retaining wire 216
can extend from the distal tip of fiber optic bundle 210 and be
coupled with tip 213. In some embodiments, retaining wire 216 and
guidewire can be the same wire.
[0045] In some embodiments, tip 213 can also include an imaging
device 260 disposed at the distal end of tip 213. Imaging device
260 can be located at least 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0 cm
longitudinally (or forward) from the distal end (or exit aperture)
of fiber optic bundle 210. Any type of imaging device can be
used.
[0046] Imaging device 260 can include any ultrasound sensor or
laser interferometry device. A laser interferometry device can
include a plurality of fiber optics with an exit aperture disposed
near the distal end of the laser catheter and extending through a
sheath of the catheter. Imaging device 260, for example, can be
formed cylindrically around tip 213 as a patch, or a ring. In some
embodiments, imaging device 260 can include any shape or size.
[0047] In some embodiments, balloon 227 can be disposed between
fiber optic bundle 210 and tip 213. In FIG. 3A balloon 227 is in
the deflated state and not shown. Balloon 227 can be coupled with a
balloon tube that can be used to inflate and/or deflate the
balloon. Balloon tube can extend proximally through at least a
portion of catheter body 205. In some embodiments, a balloon tube
coupler can be provided that allows a doctor to attach a syringe
(or other device) that can be activated to inflate and/or deflate
the balloon. FIG. 3B shows an example of laser catheter 300 with
balloon 227 inflated. As seen, balloon 227 can be inflated in order
to laterally shift the exit aperture of fiber optic bundle 210
relative to tip 213.
[0048] FIG. 4A shows a cross section of catheter 300 along line A-A
according to some embodiments. As shown, catheter body 205
surrounds a plurality of fiber optics 217, guidewire lumen 240,
balloon tube 230, and imaging wire bundle 235. In some embodiments,
balloon tube 230 can have an outside diameter of about 0.008,
0.009, 0.010. 0.011, 0.012, 0.013, 0.014, or 0.015 inches. Any of
these components may be included in a different combination or
order, or excluded altogether. Guidewire 215 is shown within
guidewire lumen 240. In some embodiments, balloon tube 235 and/or
guidewire lumen 230 can be disposed within a sheath and/or a
tube.
[0049] FIG. 4B shows a cross section of catheter 200 along line B-B
according to some embodiments. In this embodiment, tip 213 includes
balloon 206 in a deflated state. At some point, balloon tube 230
terminates within or at the boundary of balloon 206. Thus, balloon
tube 230 can terminate at a number of different positions within
balloon 206. Imaging wire bundle 235 extends through balloon 206.
The junctions of imaging wire bundle 235 and balloon 206 can be
sealed to ensure balloon inflates without a leak at the junction.
Guidewire lumen 240 is placed concentrically within catheter body
205. In other embodiments guidewire lumen 240 can be located
anywhere within catheter body 205, for example, guidewire lumen can
be disposed eccentrically with catheter body (e.g., as shown in
FIG. 6B). In some embodiments, guidewire lumen 230 can extend
through balloon when a retaining wire is used.
[0050] FIG. 4C shows a cross section of catheter 200 along line C-C
according to some embodiments. At this point, balloon tube 230
terminated within balloon 206 and only wire bundle 235 is found
within balloon 206. FIG. 4D is a cross section of catheter 200
along line D-D showing imaging wire bundle 230 extending through
tip 213 distal from balloon 206 according to some embodiments. In
some embodiments, guidewire lumen 230 can extend through balloon
when a retaining wire is used.
[0051] FIG. 4E is a cross section of catheter 200 along line E-E.
Line E-E is distal relative to probe 260. Hence, distal tip portion
207 only includes guidewire lumen 240. In some embodiments, distal
tip portion 207 can have an inside diameter similar or slightly
larger than the outside diameter of guidewire lumen 240. FIG. 4F
shows a cross section of catheter 210 in FIG. 3B along line F-F.
Imaging wire bundle 235 is shown passing through balloon 206 while
inflated.
[0052] In some embodiments, catheter body 205 may have a diameter
of approximately 2.0 mm. Each fibers 217, for example, may be less
than about 0.1 mm. As another example, the fibers may be less than
about 0.05 mm. The fiber optics may be contained within bundle 210.
For example, bundle 210 can be about 1.0 mm by about 2.0 mm.
Guidewire lumen 230, for example, can have an inside diameter of
approximately 0.024 inches and inside diameter of approximately
0.018 inches. In other embodiments, guidewire lumen 230 may have an
outside diameter less than about 0.025 inches and/or an inside
diameter less than about 0.02 inches.
[0053] While a fiber optic bundle 210 is shown in the figures, any
type of light guide can be used. For example, a liquid light guide
and or a solid light guide can be used in place of the fiber optic
bundle without limitation.
[0054] FIG. 5A shows a side view of laser catheter 500 with ramp
505 according to one embodiment of the invention. Imaging device
260 can be found at the distal tip of the catheter body 205 forward
(more distal) than the distal tip of fiber optic bundle 210. Fiber
optic bundle 210 can be located at a first position relative to
ramp 505 and can extend from aperture 207 of catheter body 205.
Fiber optic bundle can be actuated forward into a second position
as shown in FIG. 5B, such that distal end of fiber optic bundle 210
has actuated distally up and past ramp 505 toward the distal end of
catheter 500. Retaining wire 216 can provide a restraining force on
the distal end of fiber optic bundle 210 in order to keep the
distal end substantially parallel with catheter body 205 while in
the second position. In some embodiments, guidewire 215 can extend
through a guidewire lumen through catheter body 205. In other
embodiments, retaining wire 216 and guidewire 215 can be the same
wire.
[0055] In some embodiments that include retaining wire 216,
retaining wire 216 may be detachably coupled with either or both
distal tip 213 and/or light guide 210. For example, retaining wire
216 may be connected with the distal tip using solder, clamps,
glue, fused, etc. In some embodiments, retaining wire is soldered
with radiopaque marker band 211. In other embodiments, retaining
wire 216 may be coiled around the distal tip and glued or fused
with distal tip 213. In some embodiments, retaining wire 216 may be
sandwiched between distal tip 213 and radiopaque marker band 211.
In some embodiments, retaining wire 216 may extend through a
portion of light guide 210. For example, retaining wire 216 may
extend through light guide 210 next to and/or with a plurality of
optical fibers. Retaining wire 216 may aid in retaining the
position and/or bias of the light guide when light guide is
extended up ramp 505. Retaining wire 216 may also aid in providing
the proper bias when light guide is extended up ramp 505. For
example, retaining wire 216 may be lengthened and/or include
elasticity such that biasing catheter may be more or less biased
when light guide is extended up ramp 505. In some embodiments,
retaining wire provides resistance to light guide 210 when balloon
705 is inflated and/or when light guide is extended up ramp 505,
which may align light guide 210 parallel with distal tip 213 and/or
catheter body 205.
[0056] Various other configurations of biasing laser catheters can
be used. In some embodiments, laser catheters described in U.S.
Pat. No. 7,572,254, entitled "Rapid Exchange Bias Laser Catheter
Design," which is incorporated herein by reference in its entirety,
can be used in conjunction with various aspects described herein.
Similarly, the laser catheters described in U.S. patent application
Ser. Nos. 12/406,807, entitled "Apparatus and Methods for
Directional Delivery of Laser Energy;" 12/265,441, entitled
"Biasing Laser Catheter: Monorail Design;" 12/337,190, entitled
"Eccentric Balloon Laser Catheter;" and/or 12/337,232, entitled
"Rapid Exchange Bias Laser Catheter Design," each of which are
incorporated herein by reference in their entirety, can also be
used in conjunction with various aspects described herein. For
example, laser catheters described in any of the documents
incorporated by reference can be implemented with a distal imaging
device.
[0057] FIG. 6A shows a cross section of catheter 500 along line
A-A. Catheter body 205 surrounds a number of fiber optics 217,
guidewire lumen 240, and imaging wire bundle 235. Any of these
components may be included in a different combination, order, or
excluded altogether. In some embodiments, guidewire lumen 240 can
be positioned at any position within the catheter body. In some
embodiments, balloon tube 235 and/or guidewire lumen 230 can be
disposed within a sheath and/or a tube. In some embodiments, fiber
optics 217 and/or guidewire lumen 240 can be bundled within a
sheath. Thus, when the fiber optic bundle is actuated forward fiber
optics 217 do not tangle with balloon lumen 235. Moreover, balloon
lumen, in some embodiments, can be embedded within catheter body
205.
[0058] FIG. 6B shows a cross section of catheter 500 along line
B-B. In some embodiments, guidewire lumen 217 is arranged
eccentrically within fiber optic bundle 210 as shown in the figure.
Guidewire 215 is shown within guidewire lumen 240. In other
embodiments guidewire lumen 240 can be located anywhere within
catheter body 205, for example, guidewire lumen can be disposed
concentrically within catheter body (e.g., as shown in FIG. 2B).
Imaging wire bundle 235 also extends through this portion of
catheter 500.
[0059] FIG. 6C shows a cross section of catheter 500 along line
C-C. This portion of catheter 500 includes tip 213 that extend more
distally from aperture 207 and proximal to imaging device 260.
Imaging wire bundle 235 also extends through this portion of
catheter 500. FIG. 6D shows a cross section of catheter 500 along
line D-D. This potion of catheter 500 is distal with respect to
imaging device 260 and only the guidewire lumen 240 extends through
this portion. FIG. 6E shows a cross section of catheter 500 along
line E-E showing fiber optic bundle 210 having been actuated up the
ramp as shown in FIG. 5B.
[0060] FIG. 7A shows a side view of balloon catheter 700 with
balloon 705 deflated according to another embodiment of the
invention. In the deflated state, balloon catheter 700 is somewhat
similar to catheter 200 shown in FIG. 3A. However, balloon catheter
700 differs from catheter 200 in that balloon 705 inflates radially
as shown in FIG. 7B. In some embodiments, a physician can oblate
blockage within a vessel (e.g., a human artery) using catheter 700.
Catheter 700 can be positioned in front of the blockage with
balloon 705 deflated. The laser can then be activated. During
lasing catheter 700 can ablate a central portion of the blockage
roughly the size of the exit aperture of catheter 210. In order to
ablate portions of the blockage near the vessel's interior walls,
balloon 705 can be inflated and pressed against an interior wall
within the vessel. The pressure against the interior wall can shift
the exit aperture of catheter 210 toward the opposite interior wall
within the vessel allowing catheter 700 to ablate material near the
vessel wall by activating the laser. Catheter 700 can be rotated by
the physician in order to ablate the material near other portions
of the interior wall of the vessel.
[0061] In some embodiments, catheter 700 can include imaging device
260 and in other embodiments imaging device 206 can be excluded.
Similarly, catheters in some embodiments can include radiopaque
band 211, while catheters in other embodiments do not.
[0062] FIG. 8 is a side view of balloon biasing catheter 800
according to one embodiment. A balloon biasing catheter may include
a catheter body 205 (or elongated housing) with a light guide 210
disposed within a lumen of catheter body 205 and extending from an
aperture within catheter body 205. For example, light guide 210 may
include a plurality of fiber optics. As another example, the light
guide may be a liquid light guide and/or a combination of a liquid
light guide and a fiber optic light guide. In some embodiments, the
light guide is free to slide within the lumen of the catheter body.
In some embodiments, the light guide lumen may slide relative to
the catheter body. In other embodiments, the light guide may be
fixed within the lumen of the catheter body. Light guide 210 may be
located within catheter body 205 and may extend from the proximal
end of the catheter body to the distal end of the catheter body. At
the proximal end of the catheter body, light guide 210 may
terminate with laser coupler 715. The light guide lumen may include
an aperture at or near the distal end of catheter body 205 from
which light guide 210 may extend. In some embodiments, light guide
210 may extend 1-10 mm from the aperture. In some embodiments,
light guide 210 may also include a radiopaque marker band 211 near
the distal end.
[0063] A balloon biasing catheter may also include a guidewire
lumen. The guidewire lumen may be configured to allow a guidewire
to pass and/or slide therethrough. In some embodiments, the
guidewire lumen may extend, for example, from distal guidewire port
through a portion of catheter body 205. In some embodiments, the
guidewire lumen may extend to or near the proximal end of catheter
body 205. In other embodiments, guidewire lumen may extend from the
distal end to a position proximal with the light guide aperture
and/or proximal with balloon 227. The guidewire lumen may be
configured to accept a guidewire and allow the guidewire to slide
within the guidewire lumen. Proximal guidewire port 720 may be
located anywhere along catheter body 205.
[0064] In some embodiments, catheter 800 can include balloon tube
port 725 that can be coupled with balloon 227 via a balloon tube
(e.g. balloon tube 230). In some embodiments balloon lumen may
couple with a luer fitting at balloon tube port 725. Balloon tube
port 725 can be configured to accept any type of syringe or pump
that can pressurize and depressurize balloon 227. For example, the
inner diameter of balloon lumen may be approximately 0.001 inches.
In some embodiments, the inner diameter of the balloon lumen (or
tube) may be between 0.0005 and 0.01 inches. The outside diameter
of the balloon lumen, for example, may be 0.016 inches. In some
embodiments, the outside diameter of the balloon lumen may be 0.05
to 0.005 inches. At balloon port or luer, the balloon may be
coupled with a syringe or an indeflator. Balloon 705 may be
inflated by injecting fluid through balloon lumen using either a
syringe or an indeflator. In some embodiments, the balloon may be
inflated using a contrast agent fluid or saline solution. The
balloon lumen 1813 may include any type of plastic tubing known in
the art. For example, balloon lumen 1813 may comprise nylon,
Teflon, polyethylene, etc.
[0065] Guidewire lumen port 720 can also be included. Guidewire
lumen port 720 can be coupled with guidewire lumen 240 and can
allow a guidewire to extend through the distal end toward the
proximal end of the catheter. A bifurcated cover can be used to
separate the ports from the body of the catheter.
[0066] FIG. 9A shows a cutaway of a balloon biasing catheter in use
within vessel 810 near target 805. The balloon biasing catheter may
be inserted into vessel 810 by following guidewire 215 that may
have been previously placed within vessel 810. Guidewire 215 may
run through the guidewire lumen as shown in the figure. Balloon 705
is deflated in FIG. 9A. Light guide 210 may be activated and a
portion of target 215 may be ablated. FIG. 18B shows results of
ablation of target 805 with the balloon biasing catheter positioned
as shown in FIG. 9A. Target 805 may not be completely ablated
leaving portions 806, 807. In some embodiments, a hole within
target 805 may result.
[0067] FIG. 9B shows light guide 210 biased axially by inflating
balloon 705. When balloon 705 is inflated, the laser catheter can
be axially biased toward target portion 807. Moreover, balloon 705
may be partially or fully inflated as needed to align light guide
210 with target portion 807. FIG. 10A shows a resulting example of
ablation using the configuration in FIG. 9B. Target portion 807 has
been at least partially ablated. In some embodiments, target
portion 807 may be completely ablated.
[0068] After ablation of target portion 807, balloon 705 can be
deflated and the catheter rotated within vessel 810 as shown in
FIG. 10A. As shown in FIG. 10B, balloon 705 can be inflated
positioning light guide 210 toward target portion 806. In some
embodiments, balloon 705 may remain inflated during rotation. In
some embodiments, balloon biasing catheter and/or guidewire 215 may
be advanced during any of the ablation steps. In some embodiments,
balloon biasing catheter may be rotated 90.degree. or any other
angle in order to ablate other target portions and/or material near
or adhering to a vessel wall. In some embodiments, during ablation
as shown in FIGS. 9A, 9B, 10A and 10B, imaging of the interior of
vessel 810 can occur using imaging device 260.
[0069] In some embodiments, laser catheters can include a balloon
(e.g., balloon 705). Such balloons, for example, can have a
diameter of about 1 mm to 3 mm when inflated. In some embodiments,
balloon may have an inflated diameter up to about 5 mm and as
little as 0.5 mm. In some embodiments, the balloon may comprise a
portion of tubing with a sealed distal end. In some embodiments, a
portion of tubing may form the balloon and have thinner walls
and/or a larger diameter such that the balloon portion of the
tubing inflates under pressure. A balloon, for example, may
comprise any type of plastic, for example, the balloon may comprise
nylon, Teflon, polyethylene, etc. A balloon, in some embodiments,
may extend the entire length of distal tip 213. For example,
balloon 705 may be 10 cm, 9 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm,
2 cm, or 1 cm in length.
[0070] In some embodiments, a balloon can be used to deflect a
light guide, fiber optic bundle and/or catheter body. In doing so,
the balloon, for example, may deflect the light guide, fiber optic
bundle and/or catheter body 205 1.0 mm. In other embodiments, the
light guide, fiber optic bundle and/or catheter body may be biased
0.5 mm, 1.5 mm, 2.0 mm, 2.5 mm, 3.0 mm etc. from a deflated
position. By biasing the light guide, fiber optic bundle and/or
catheter body, the balloon biasing catheter may ablate a larger
diameter area than if the light guide is not biased.
[0071] FIG. 11 shows a flowchart of a process for using a biasing
catheter according to one embodiment. Various other processes may
be used that add to or take away from the process shown in FIG. 11
and described below. The proximal end of a guidewire is inserted
through the distal guidewire port at the distal tip of the balloon
biasing catheter at block 1005. The balloon biasing catheter may
then be inserted into a vessel at block 1010 and slid over the
guidewire and positioned near a target at block 1015. At block 1020
the laser may be activated ablating a portion of the target area.
The balloon biasing catheter may be advanced at block 1023. Once
ablation is complete, the laser is deactivated at block 1025. If
portions of the target are not completely ablated, for example, if
material remains near the vessel walls, then the balloon may be
inflated at block 1030. When the balloon is inflated the distal tip
of the balloon biasing catheter may be radially biased yet
substantially parallel with the balloon biasing catheter and
positioned to ablate unablated portions of the target. The laser
may again be activated at block 1035 and portions of the target
ablated. At block 1038 the balloon biasing catheter may be advanced
toward the target. At block 1040 the laser is deactivated after a
period of time and the balloon deflated at block 1045. If the
ablation area is satisfactory and no more ablation is required as
decided at block 1050 the balloon biasing catheter is removed at
block 1060. However, if more ablation is required, the balloon
biasing catheter may be rotated axially within the vessel at block
1055 and the process returns to block 1030.
[0072] FIG. 12 shows a flowchart of a process for using a biasing
catheter according to one embodiment. This flow chart is
substantially similar to the flowchart shown in FIG. 11. In this
embodiment, however, at blocks 1123 and 1138 the light guide is
advanced relative to the balloon biasing catheter. In such
embodiments, the catheter body remains substantially still as the
light guide is advanced to ablate target material.
[0073] While FIG. 11 and FIG. 12 are described in conjunction with
a balloon biasing catheter, other types of biasing catheters can be
used. For example, biasing catheters as those shown in FIG. 5A can
also be used.
[0074] FIG. 13 is a flowchart describing another embodiment for
using a biasing catheter in conjunction with an imaging device.
Blocks 1005, 1010, and 1015 are similar to those described above in
conjunction with FIG. 11. According to some embodiments, once the
bias catheter has been positioned within a vessel (e.g., at block
1015), the interior of the vessel can be imaged using an imaging
device (e.g., an ICUS/IVUS device). In some embodiments, the image
of the interior of the vessel can be displayed on a display (e.g.,
the display associated with computer 180 shown in FIG. 1) such that
a physician or doctor can view the interior of the vessel. In some
embodiments, based on the image provided, the doctor can reposition
the laser catheter.
[0075] At block 1210 if the laser is activated images produced by
the imaging device can be filtered at block 1215. In some
embodiments, the filtering can occur in real time. In other
embodiments, the filtering can occur after the imaging has
occurred. In some embodiments, filtering can occur by disabling the
imaging device while the laser is activated. Moreover, imaging can
be filtered for an extended period of time beyond the time the
laser is activated. Filtering can also occur at a display, such
that, images produced while the laser is activated are not
displayed to a user. If the laser is not activated at block 1215,
the interior of the vessel can continued to be imaged at block
1210.
[0076] At block 1220, if the laser is not deactivated, images of
the interior of the vessel can continue to be filtered at block
1215. Otherwise, the process continues to block 1225. At block
1225, if the procedure is not complete, the process returns to
block 1205, otherwise imaging ceases at block 1230.
[0077] Various embodiments disclosed herein describe the use of an
imaging device in conjunction with a laser catheter. Any type of
imaging can be used. For example, the imaging device can include an
ultrasound sensor or a laser interferometry device. A laser
interferometry device can include a plurality of fiber optics with
an exit aperture disposed near the distal end of the laser catheter
and extending through a sheath of the catheter. The imaging device,
for example, can be formed cylindrically, as a patch, or a
ring.
[0078] An ultrasound device can include an
Intracoronary/Intravascular Ultrasound (ICUS/IVUS) device that can
employ very small transducers arranged on a catheter and provides
electronic transduced echo signals to an external imaging system in
order to produce a two or three-dimensional image of the lumen, the
arterial tissue, plaque, blockages, and/or tissue surrounding the
artery. These images can be generated in substantially real time
and can provide images of superior quality to the known x-ray
imaging methods and apparatuses. Other imaging methods and
intravascular ultrasound imaging applications would also benefit
from enhanced image resolution. An ultrasound device, for example,
can include a flexible polyimide film layer.
[0079] In some embodiments of the invention, imaging can be gated
while the laser catheter is pulsing. Signal processing techniques
can be implemented (e.g. at computer 180 in FIG. 1) that filters
out optical, mechanical, and electronic interference effects. An
electron plasma can be created within the vessel during ablation.
This electron plasma can interfere with imaging from an imaging
device (e.g. imaging device 260). In some embodiments,
electromagnetic interference can be avoided by filtering out data
during the set time period while the laser is pulsing. In other
embodiments, filtering can occur for a longer duration such as for
a period greater than the pulsing period. For example, filtering
can occur 30%, 40%, 50%, 60%, or 70% longer than the laser pulsing
period in order to filter out any latent electromagnetic
interference. For example, if the laser pulses laser light for 135
ns, filtering can eliminate imaging data during the 200 ns after
the beginning of the pulse and/or data capture can be delayed for
200 ns after the beginning of the pulse.
[0080] Moreover, photochemical effects in an area ablated by a
laser catheter can remain for up to about 0.6 ms. Thus, imaging
data recorded using a forward imaging device can also include
filtering data recorded 0.4, 0.5, 0.6, 0.7, 0.8, 1.0, 1.1, 1.2, 1.3
or 1.4 ms after the laser pulse has begun. Thus, for example,
signal capture (or data retention) can begin after 1.0 ms after the
beginning of the laser pulse. Delaying signal capture until 1 ms
after the laser pulse still allows for a better than 10 frames per
second data acquisition and signal processing even operating at 80
Hz.
[0081] In some embodiments, elimination of data using filtering
techniques can be implemented in software operating at computer
180. In other embodiments, dedicated electrical circuitry can be
used to filter the data after the data has been received. In some
embodiments, data filtering can occur well after the imaging data
has been captured and recorded. In yet other embodiments, filtering
can occur in real time. That is, for example, the data from the
imaging device can be ignored, deleted, or not displayed while the
laser is active and/or during some post activation time period. As
another example, the imaging device can be disabled during
filtering periods. In other embodiments, gating can prevent images
from being displayed on a display (e.g., a display associated with
computer 180 shown in FIG. 1) while the laser catheter is
activated.
[0082] In some embodiments, the laser can be electrically,
mechanically, or optically interrupted to allow for data
acquisition. For example, imaging can occur at predetermined
intervals during which laser pulses are stopped to allow for better
imaging. As another example, imaging can be initiated by a doctor
or technician. During this time, the laser can be deactivated to
allow for better imaging. Once imaging is complete, the laser can
be reactivated and pulsing can recommence (whether automatically or
manually).
[0083] Circuits, logic modules, processors, and/or other components
may be described herein as being "configured" to perform various
operations. Those skilled in the art will recognize that, depending
on implementation, such configuration can be accomplished through
design, setup, interconnection, and/or programming of the
particular components and that, again depending on implementation,
a configured component might or might not be reconfigurable for a
different operation. For example, a programmable processor can be
configured by providing suitable executable code; a dedicated logic
circuit can be configured by suitably connecting logic gates and
other circuit elements; and so on.
[0084] While embodiments of the invention are described herein with
reference to particular blocks, it is to be understood that the
blocks are defined for convenience of description and are not
intended to imply a particular physical arrangement of component
parts. Further, the blocks need not correspond to physically
distinct components.
[0085] While the embodiments described above may make reference to
specific hardware and software components, those skilled in the art
will appreciate that different combinations of hardware and/or
software components may also be used and that particular operations
described as being implemented in hardware might also be
implemented in software or vice versa.
[0086] Computer programs incorporating various features of the
present invention may be encoded on various computer readable
storage media; suitable media include magnetic disk or tape,
optical storage media such as compact disk (CD) or digital
versatile disk (DVD), flash memory, and the like. Computer readable
storage media encoded with the program code may be packaged with a
compatible device or provided separately from other devices. In
addition program code may be encoded and transmitted via wired
optical, and/or wireless networks conforming to a variety of
protocols, including the Internet, thereby allowing distribution,
e.g., via Internet download.
* * * * *