U.S. patent application number 17/668757 was filed with the patent office on 2022-07-14 for micro-optic probes for neurology.
The applicant listed for this patent is GENTUITY, LLC. Invention is credited to Michael Atlas, Nareak Douk, J. Christopher Flaherty, David W. Kolstad, Christopher L. Petersen, Christopher C. Petroff.
Application Number | 20220218206 17/668757 |
Document ID | / |
Family ID | |
Filed Date | 2022-07-14 |
United States Patent
Application |
20220218206 |
Kind Code |
A1 |
Petroff; Christopher C. ; et
al. |
July 14, 2022 |
MICRO-OPTIC PROBES FOR NEUROLOGY
Abstract
An imaging system for a patient comprises an imaging probe. The
imaging probe comprises: an elongate shaft for insertion into the
patient and comprising a proximal end, a distal portion, and a
lumen extending between the proximal end and the distal portion; a
rotatable optical core comprising a proximal end and a distal end,
the rotatable optical core configured to optically and mechanically
connect with an interface unit; a probe connector positioned on the
elongate shaft proximal end and surrounding at least a portion of
the rotatable optical core and an optical assembly positioned in
the elongate shaft distal portion and proximate the rotatable
optical core distal end, the optical assembly configured to direct
light to tissue and collect reflected light from the tissue. A
shear-thinning fluid can be provided between the elongate shaft and
the rotatable optical core, such as to reduce undesired rotational
variations of the rotatable optical core.
Inventors: |
Petroff; Christopher C.;
(Groton, MA) ; Atlas; Michael; (Arlington, MA)
; Kolstad; David W.; (Carlisle, MA) ; Petersen;
Christopher L.; (Carlisle, MA) ; Douk; Nareak;
(Lowell, MA) ; Flaherty; J. Christopher;
(Nottingham, NH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
GENTUITY, LLC |
Sudbury |
MA |
US |
|
|
Appl. No.: |
17/668757 |
Filed: |
February 10, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15566041 |
Oct 12, 2017 |
11278206 |
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PCT/US2016/027764 |
Apr 15, 2016 |
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17668757 |
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62148355 |
Apr 16, 2015 |
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62322182 |
Apr 13, 2016 |
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International
Class: |
A61B 5/00 20060101
A61B005/00; A61B 1/07 20060101 A61B001/07; G02B 6/36 20060101
G02B006/36 |
Claims
1. (canceled)
2. An imaging system for a patient comprising: an imaging probe
comprising: an elongate shaft for insertion into the patient and
comprising a proximal end, a distal portion, and a lumen extending
between the proximal end and the distal portion; a rotatable
optical core comprising a proximal end and a distal end, the
rotatable optical core configured to optically and mechanically
connect with a console; a probe connector positioned on the
elongate shaft proximal end and surrounding at least a portion of
the rotatable optical core; and an optical assembly positioned in
the elongate shaft distal portion and proximate the rotatable
optical core distal end, the optical assembly configured to direct
light to tissue and collect reflected light from the tissue;
wherein the imaging probe is constructed and arranged to collect
image data from a patient site based on the directed light and the
reflected light, wherein the optical assembly is configured to be
positioned within a first blood vessel proximate a patient site and
to collect the image data from the patient site, and wherein the
patient site comprises a location outside of the blood vessel.
3. The imaging system according to claim 2, wherein the patient
site comprises a location within the intrathecal space of the
spine.
4. The imaging system according to claim 2, wherein the patient
site comprises a location within a second blood vessel that is
outside of the first blood vessel.
5. The imaging system according to claim 2, wherein the patient
site comprises a location within tissue that is outside of the
first blood vessel.
6. The imaging system according to claim 2, wherein the imaging
probe is configured to access blood vessels of the brain.
7. The imaging system according to claim 2, wherein the optical
assembly comprises an outer diameter that is greater than an inner
diameter of at least a portion of the elongate shaft proximal to
the optical assembly.
8. The imaging system according to claim 2, wherein the imaging
system includes a sensor that receives a signal related to the
tissue, the console configured to process the signal, and a display
configured to display a three-dimensional image from an output of
the console in response to a retraction of the elongate shaft.
9. The imaging system according to claim 2, wherein the elongate
shaft distal portion comprises an optically transparent window, and
wherein the optical assembly is positioned within the optically
transparent window.
10. The imaging system according to claim 9, wherein the optically
transparent window comprises a length less than 20 mm.
11. The imaging system according to claim 2, wherein the rotatable
optical core is constructed and arranged to rotate in a single
direction.
12. The imaging system according to claim 2, further comprising a
retraction assembly constructed and arranged to retract the
elongate shaft and the optical assembly while the imaging probe
collects data from a target area.
13. The imaging system according to claim 2, wherein the imaging
probe of the imaging system is configured to provide to the console
quantitative or qualitative information used to determine the size
of a flow diverter of an implant to be implanted in the patient or
position a flow diverter in the patient.
14. The imaging system according to claim 13, wherein the
quantitative and/or qualitative information comprises information
related to a parameter selected from the group consisting of:
perforator location; perforator geometry; neck size; flow diverter
mesh density; and combinations thereof.
15. The imaging system according to claim 2, wherein the imaging
probe of the imaging system is configured to provide implant site
information, and wherein the implant site information is used to
select a particular implantable device for implantation in the
patient.
16. The imaging system according to claim 2, wherein the imaging
probe further comprises a torque shaft with a proximal end and a
distal end, and wherein the torque shaft is fixedly attached to the
rotatable optical core such that rotation of the torque shaft
rotates the rotatable optical core.
17. The imaging system according to claim 2, further comprising a
rotation assembly constructed and arranged to rotate the rotatable
optical core.
18. The imaging system according to claim 2, wherein the console
comprises: a rotation assembly constructed and arranged to rotate
the rotatable optical core; and a retraction assembly constructed
and arranged to retract at least one of the rotatable optical core
or the elongate shaft.
Description
RELATED APPLICATIONS
[0001] This application is a continuation application of U.S.
patent application Ser. No. 15/566,041 (Docket No. GTY-001-US),
titled "Micro-Optic Probes for Neurology", filed Oct. 12, 2017,
United States Publication Number 2018-0125372, published May 10,
2018, which in a National Phase entry of International PCT Patent
Application Serial Number PCT/US2016/027764 (Docket No.
GTY-001-PCT), titled "Micro-Optic Probes for Neurology" filed Apr.
15, 2016, Publication Number WO 2016/168605, published Oct. 20,
2016, which claims the benefit of: U.S. Patent Provisional
Application Ser. No. 62/322,182, titled "Micro Optic Probes for
Neurology", filed Apr. 13, 2016 and U.S. Provisional Application
Ser. No. 62/148,355, titled "Micro-Optic Probes for Neurology",
filed Apr. 16, 2015, the content of each of which is incorporated
herein by reference in its entirety for all purposes. This
application is related to: U.S. Provisional Application Ser. No.
62/212,173, titled "Imaging System includes Imaging Probe and
Delivery Devices", filed Aug. 31, 2015; the content of which is
incorporated herein by reference in its entirety for all
purposes.
FIELD
[0002] Inventive concepts relate generally to imaging systems, and
in particular, neural imaging systems including imaging probes,
imaging consoles and delivery devices.
BACKGROUND
[0003] Imaging probes have been commercialized for imaging various
internal locations of a patient, such as an intravascular probe for
imaging a patient's heart. Current imaging probes are limited in
their ability to reach certain anatomical locations due to their
size and rigidity. Current imaging probes are inserted over a
guidewire, which can compromise their placement and limit use of
one or more delivery catheters through which the imaging probe is
inserted. There is a need for imaging systems that include probes
with reduced diameter, high flexibility and ability to be advanced
to a patient site to be imaged without a guidewire, as well as
systems with one or more delivery devices compatible with these
improved imaging probes.
SUMMARY
[0004] According to one aspect of the present inventive concepts,
an imaging system for a patient comprises: an imaging probe and is
configured to produce an image of the patient. The imaging probe
comprises: an elongate shaft for insertion into the patient and
comprising a proximal end, a distal portion, and a lumen extending
between the proximal end and the distal portion; a rotatable
optical core comprising a proximal end and a distal end, the
rotatable optical core configured to optically and mechanically
connect with an interface unit; a probe connector positioned on the
elongate shaft proximal end and surrounding at least a portion of
the rotatable optical core; and an optical assembly positioned in
the elongate shaft distal portion and proximate the rotatable
optical core distal end, the optical assembly configured to direct
light to tissue and collect reflected light from the tissue.
[0005] In some embodiments, the imaging probe comprises a
shear-thinning fluid located within the distal portion of the
elongate shaft, such as a shear-thinning fluid configured to reduce
undesired rotational variances of the rotatable optical core (e.g.
and the attached optical assembly 130) while avoiding excessive
loads being placed on the rotatable optical core.
[0006] In some embodiments, the imaging probe further comprises at
least one space reducing element positioned between the elongate
shaft and the rotatable optical core, and the at least one space
reducing element can be configured to reduce rotational speed
variances of the rotatable optical core. The at least one space
reducing element can be positioned at least in a portion of the
elongate shaft distal portion. The at least one space reducing
element can be configured to reduce the rotational speed variances
by increasing the shear-thinning of the shear-thinning fluid.
[0007] In some embodiments, the imaging probe further comprises an
inertial assembly configured to reduce rotational speed variances
of the rotatable optical core.
[0008] In some embodiments, the imaging probe further comprises an
impeller attached to the rotatable optical core and configured to
resist rotation of the rotatable optical core when the rotatable
optical core is retracted.
[0009] In some embodiments, the imaging probe further comprises a
stiffening element embedded into the elongate shaft that is
configured to resist flexing of the elongate shaft and comprises an
optically transparent portion.
[0010] In some embodiments, the imaging probe further comprises a
reduced inner diameter portion of the elongate shaft, wherein the
reduced inner diameter portion is configured to reduce rotational
speed variances of the rotatable optical core.
[0011] In some embodiments, the imaging system is configured to
create a three dimensional image by retraction of the elongate
shaft.
[0012] In some embodiments, the imaging system is configured to
detect and/or quantify malapposition of a flow diverter implanted
in the patient.
[0013] In some embodiments, the imaging system is configured to
provide quantitative and/or qualitative information used to
determine the size of a flow diverter to be implanted in the
patient and/or position a flow diverter in the patient. The
quantitative and/or qualitative information can comprise
information related to a parameter selected from the group
consisting of: perforator location; perforator geometry; neck size;
flow diverter mesh density; and combinations thereof.
[0014] In some embodiments, the imaging system is configured to
image a stent retriever at least partially positioned in thrombus
of the patient. The imaging system can be configured to image
thrombus at least one of: thrombus not engaged with the stent
retriever or thrombus not removed by the stent retriever.
[0015] In some embodiments, the imaging system is configured to
quantify a volume of thrombus in the patient. The quantified
thrombus can comprise thrombus selected from the group consisting
of: residual thrombus in acute stroke; thrombus remaining after a
thrombus removal procedure; thrombus present after flow diverter
implantation; and combinations thereof.
[0016] In some embodiments, the imaging system is configured to
provide implant site information, and the implant site information
is used to select a particular implantable device for implantation
in the patient. The system can further comprise the implantable
device for implantation in the patient, and the implantable device
can comprise a device selected from the group consisting of: stent;
flow diverter; and combinations thereof. The implantable device can
be selected based on an implantable device parameter selected from
the group consisting of: porosity; length; diameter; and
combinations thereof.
[0017] In some embodiments, the imaging system is configured to
provide porosity information of a device implanted in the patient.
The porosity information can comprise porosity of a portion of the
implanted device that is to be positioned proximate a sidebranch of
a vessel in which the implanted device is positioned. The system
can be configured to provide the porosity information based on a
wire diameter of the implanted device. The system can further
comprise the implanted device, and the implanted device can
comprise a device selected from the group consisting of: stent;
flow diverter; and combinations thereof. The imaging system can be
further configured to provide information related to implanting a
second device in the patient. The first implanted device can
comprise a stent, and the second implanted device can comprise a
flow diverter. The first implanted device can comprise a flow
diverter and the second implanted device can comprise a flow
diverter. The imaging system can be further configured to provide
an image during deployment of the implanted device. The imaging
system can be further configured to allow modification of the
implanted device while the optical assembly is positioned proximate
the implanted device. The modification can comprise a modification
of the porosity of the implanted device. The system can further
comprise a balloon catheter configured to perform the porosity
modification.
[0018] In some embodiments, the imaging system is configured to
image at least one perforator artery of the patient. The at least
one perforator artery can comprise a diameter of at least 50 .mu.m.
The system can further comprise a therapeutic device. The
therapeutic device can comprise a device selected from the group
consisting of: stent retriever; embolization coil; embolization
coil delivery catheter; stent; covered stent; stent delivery
device; aneurysm treatment implant; aneurysm treatment implant
delivery device; flow diverter; balloon catheter; and combinations
thereof.
[0019] In some embodiments, the system further comprises at least
one guide catheter. The at least one guide catheter can comprise a
microcatheter. The microcatheter can comprise an inner diameter
between 0.0165'' and 0.027''. The microcatheter can comprise an
inner diameter between 0.021'' and 0.027''.
[0020] In some embodiments, the imaging probe is constructed and
arranged to access a vessel of a human being.
[0021] In some embodiments, the imaging probe is configured to
access blood vessels of the brain.
[0022] In some embodiments, the elongate shaft comprises a material
selected from the group consisting of: FEP; PTFE; Pebax; PEEK;
Polyimide; Nylon; and combinations thereof.
[0023] In some embodiments, the elongate shaft comprises a material
selected from the group consisting of: stainless steel; nickel
titanium alloy; and combinations thereof.
[0024] In some embodiments, the elongate shaft comprises a first
portion comprising a metal tube and a second portion comprising a
braided shaft.
[0025] In some embodiments, the elongate shaft comprises a
hydrophobic material configured to reduce changes in length of the
elongate shaft when the elongate shaft is exposed to a fluid.
[0026] In some embodiments, the elongate shaft comprises an outer
diameter that varies along the length of the elongate shaft.
[0027] In some embodiments, the elongate shaft comprises an inner
diameter that varies along the length of the elongate shaft.
[0028] In some embodiments, the elongate shaft comprises an outer
diameter between 0.006'' and 0.022''.
[0029] In some embodiments, the elongate shaft comprises an outer
diameter of approximately 0.0134''.
[0030] In some embodiments, the elongate shaft comprises an inner
diameter between 0.004'' and 0.012''. The elongate shaft can
comprise a wall thickness of approximately 0.003''.
[0031] In some embodiments, the elongate shaft comprises an outer
diameter less than or equal to 500 .mu.m.
[0032] In some embodiments, the elongate shaft comprises an outer
diameter less than or equal to 1 mm.
[0033] In some embodiments, the elongate shaft comprises an outer
diameter of approximately 0.016''. At least the most distal 30 cm
of the elongate shaft can comprise an outer diameter less than or
equal to 0.016''.
[0034] In some embodiments, the elongate shaft can comprise an
outer diameter of approximately 0.014''. The elongate shaft can be
configured to be advanced through vasculature without a guidewire
or delivery device. At least the most distal 30 cm of the elongate
shaft can comprise an outer diameter less than or equal to
0.014''.
[0035] In some embodiments, the elongate shaft comprises a mid
portion proximal to the distal portion, and the distal portion
comprises a larger outer diameter than the mid portion. The
elongate shaft distal portion can comprise a larger inner diameter
than the inner diameter of the mid portion. The larger outer
diameter distal portion can surround the optical assembly.
[0036] In some embodiments, the elongate shaft comprises a length
of at least 100 cm. The elongate shaft can comprise a length of no
more than 350 cm.
[0037] In some embodiments, the elongate shaft comprises a length
of at least 200 cm. The elongate shaft can comprise a length of at
least 220 cm. The elongate shaft can comprise a length of at least
240 cm. The elongate shaft can comprise a length of approximately
250 cm.
[0038] In some embodiments, the elongate shaft further comprises a
middle portion, and the elongate shaft distal portion comprises a
larger inner diameter than the elongate shaft middle portion. The
elongate shaft distal portion inner diameter can be at least
0.002'' larger than the inner diameter of the elongate shaft middle
portion. The elongate shaft distal portion can comprise a similar
outer diameter to the outer diameter of the elongate shaft middle
portion. The elongate shaft distal portion can comprise an outer
diameter than is greater than the elongate shaft middle portion
outer diameter. The elongate shaft distal portion outer diameter
can be at least 0.001'' larger than the outer diameter of the
elongate shaft middle portion. The elongate shaft distal portion
can comprise a wall thickness that is less than the elongate shaft
middle portion wall thickness. The elongate shaft distal portion
can comprise a stiffer material than the elongate shaft middle
portion. The elongate shaft distal portion can comprise a
stiffening element.
[0039] In some embodiments, the elongate shaft distal portion
comprises a rapid exchange guidewire lumen. The guidewire lumen can
comprise a length of less than or equal to 150 mm. The guidewire
lumen can comprise a length of at least 15 mm. The guidewire lumen
can comprise a length of at least 25 mm.
[0040] In some embodiments, the elongate shaft distal portion
comprises an optically transparent window, and the optical assembly
is positioned within the optically transparent window. The
optically transparent window can comprise a length less than 20 mm,
or less than 15 mm. The optically transparent window can comprise a
material selected from the group consisting of: Pebax; Pebax 7233;
PEEK; amorphous PEEK; polyimide; glass; sapphire; nylon 12; nylon
66; and combinations thereof. The elongate shaft can comprise at
least a first portion, positioned proximate the optically
transparent window, and the first portion can comprise a braided
shaft. The elongate shaft can further comprise a second portion
positioned proximal to the first portion, and the second portion
can comprise a metal tube. The optically transparent window can
comprise a length between 1 mm and 100 mm. The optically
transparent window can comprise a length of approximately 3 mm. The
optically transparent window can comprise a material selected from
the group consisting of: nylon; nylon 12; nylon 66; and
combinations thereof.
[0041] In some embodiments, the elongate shaft comprises a
stiffening element. The stiffening element can be positioned at
least in the elongate shaft distal portion. The stiffening element
can be constructed and arranged to resist rotation of the elongate
shaft distal portion during rotation of the rotatable optical core.
The stiffening element can terminate proximal to the optical
assembly. The stiffening element can comprise a coil. The
stiffening element can comprise metal coils wound over PTFE. The
stiffening element can comprise a coil wound in a direction such
that rotation of the rotatable optical core tightens the metal
coil. The imaging probe can further comprise a fluid positioned
between the rotatable optical core and the elongate shaft, and the
metal coil can be configured to reduce twisting of the elongate
shaft by torque forces applied by the fluid.
[0042] In some embodiments, the elongate shaft comprises a distal
end, and the imaging probe comprises a spring tip attached to the
elongate shaft distal end. The spring tip can comprise a radiopaque
portion. The spring tip can comprise a length between 2 cm and 3
cm.
[0043] In some embodiments, the elongate shaft comprises a proximal
portion constructed and arranged to be positioned in a service
loop, and the elongate shaft proximal portion has a different
construction than the remainder of the elongate shaft. The
different construction can comprise a larger outer diameter. The
different construction can comprise a thicker wall.
[0044] In some embodiments, the system further comprises a fluid
positioned in the elongate shaft lumen, and a fluid interacting
element positioned in the distal portion of the lumen of the
elongate shaft, and the fluid interacting element is configured to
interact with the fluid to increase load on the rotatable optical
core during rotation of the rotatable optical core. The fluid
interacting element can comprise a coil positioned in the elongate
shaft lumen. The fluid interacting element can comprise a
non-circular cross section of the lumen. The non-circular cross
section can comprise a geometry selected from the group consisting
of: polygon shaped cross section of a lumen of the elongate shaft;
projections into a lumen of the elongate shaft; recesses in inner
diameter of the elongate shaft; and combinations thereof. The fluid
can comprise a low viscosity fluid. The fluid can comprise a
viscosity at or below 1000 Cp.
[0045] In some embodiments, the imaging probe further comprises a
first sealing element located within the elongate shaft lumen, the
sealing element positioned between the rotatable optical core and
the elongate shaft, and configured to slidingly engage the
rotatable optical core and to resist the flow of fluid around the
sealing element (e.g. to provide a seal as the rotatable optical
core is rotated). The first sealing element can be positioned in
the elongate shaft distal portion. The imaging probe can further
comprise a first liquid positioned proximate the optical assembly
and a second fluid positioned proximate the rotatable optical core,
and the first sealing element can be positioned between the first
liquid and the second liquid. The first liquid can comprise a first
viscosity and the second liquid can comprise a second viscosity
greater than the first viscosity. The first sealing element can be
further configured to resist rotation of the rotatable optical
core. The first sealing element can comprise a hydrogel. The first
sealing element can comprise an adhesive bonded to the elongate
shaft. The first sealing element can comprise a UV-cured adhesive
bonded to the elongate shaft. The rotatable optical core can
comprise a material that does not bond to the adhesive. The first
sealing element can comprise a compliant material. The compliant
material can comprise silicone. The system can further comprise a
second sealing element positioned between the rotatable optical
core and the elongate shaft, and the second sealing element can be
configured to slidingly engage the rotatable optical core and can
be further configured to resist flow of fluid around the second
sealing element, and the imaging probe can further comprise a fluid
positioned between the first sealing element and the second sealing
element. The first and second sealing elements can be separated by
a distance of between 1 mm and 20 mm. The fluid positioned between
the first and second sealing elements can comprise a viscosity
between 10 Cp and 100 Cp. The first sealing element can be
positioned proximal and proximate the optical assembly and the
second sealing element can be positioned distal to the first
sealing element.
[0046] In some embodiments, the imaging probe comprises a sealing
element positioned proximate the proximal end of the elongate
shaft. The sealing element can be positioned between the elongate
shaft and the probe connector.
[0047] In some embodiments, the rotatable optical core comprises a
single mode glass fiber with an outer diameter between 40 .mu.m and
175 .mu.m.
[0048] In some embodiments, the rotatable optical core comprises a
single mode glass fiber with an outer diameter between 80 .mu.m and
125 .mu.m.
[0049] In some embodiments, the rotatable optical core comprises a
polyimide coating.
[0050] In some embodiments, the rotatable optical core comprises an
outer diameter between 60 .mu.m and 175 .mu.m. The rotatable
optical core can comprise an outer diameter of approximately 110
.mu.m.
[0051] In some embodiments, the rotatable optical core comprises a
material selected from the group consisting of: silica glass;
plastic; polycarbonate; and combinations thereof.
[0052] In some embodiments, the rotatable optical core comprises a
numerical aperture of approximately 0.11.
[0053] In some embodiments, the rotatable optical core comprises a
numerical aperture of at least 0.11.
[0054] In some embodiments, the rotatable optical core comprises a
numerical aperture of approximately 0.16.
[0055] In some embodiments, the rotatable optical core comprises a
numerical aperture of approximately 0.20.
[0056] In some embodiments, the rotatable optical core is
constructed and arranged to rotate in a single direction.
[0057] In some embodiments, the rotatable optical core is
constructed and arranged to rotate in two directions.
[0058] In some embodiments, the rotatable optical core is
configured to be retracted within the elongate shaft. The system
can further comprise purge media introduced between the rotatable
optical core and the elongate shaft. The purge media can provide a
function selected from the group consisting of: index matching;
lubrication; purging of bubbles; and combinations thereof.
[0059] In some embodiments, the optical assembly comprises an outer
diameter between 80 .mu.m and 500 .mu.m. The optical assembly can
comprise an outer diameter of approximately 150 .mu.m.
[0060] In some embodiments, the optical assembly comprises an outer
diameter of at least 125 .mu.m.
[0061] In some embodiments, the optical assembly comprises a length
between 200 .mu.m and 3000 .mu.m. The optical assembly can comprise
a length of approximately 1000 .mu.m.
[0062] In some embodiments, the optical assembly comprises a lens.
The lens can comprise a GRIN lens. The lens can comprise a focal
length between 0.5 mm and 10.0 mm. The lens can comprise a focal
length of approximately 2.0 mm. The lens can comprise a ball
lens.
[0063] In some embodiments, the optical assembly comprises a
reflecting element.
[0064] In some embodiments, the optical assembly comprises a lens,
a reflecting element and a connecting element, and the connecting
element positions the reflecting element relative to the lens. The
connecting element can comprise an element selected from the group
consisting of: tube; flexible tube; heat shrink; optically
transparent arm; and combinations thereof. The connecting element
can position the reflecting element a distance of between 0.01 mm
and 3.0 mm from the lens. The connecting element can position the
reflecting element a distance of between 0.01 mm and 1.0 mm from
the lens. The reflecting element can comprise a cleaved portion of
a larger assembly. The reflecting element can comprise a segment of
a wire. The wire can comprise a gold wire. The lens can comprise a
GRIN lens. The lens can have at least one of an outer diameter of
150 .mu.m or a length of 1000 .mu.m. The lens can further comprise
a coreless lens positioned proximal to and optically connected to
the GRIN lens.
[0065] In some embodiments, the imaging probe comprises the
inertial assembly, and the inertial assembly is positioned
proximate the optical assembly.
[0066] In some embodiments, the imaging probe comprises the
inertial assembly, and the inertial assembly further comprises a
wound hollow core cable comprising a proximal end and a distal end,
the distal end of the wound hollow core cable being affixed to the
rotatable optical core at a location proximal to the optical
assembly, and the proximal end of the wound hollow core cable being
unattached to the optical core.
[0067] In some embodiments, the imaging probe comprises the
inertial assembly, and the inertial assembly comprises fluid within
the elongate shaft lumen and a mechanical resistance element
positioned on the distal portion of the optical core, and the
mechanical resistance element is in contact with the fluid and
configured to resist rotation of the rotatable optical core.
[0068] In some embodiments, the imaging probe comprises the
inertial assembly, and the inertial assembly is constructed and
arranged to provide inertial dampening which increases with
rotational speed.
[0069] In some embodiments, the imaging probe comprises the
inertial assembly, and the inertial assembly comprises a projection
from the rotatable optical core. The projection can be constructed
and arranged to frictionally engage the elongate shaft. The
projection can be constructed and arranged to cause shear force
that applies a load to the rotatable optical core during
rotation.
[0070] In some embodiments, the imaging probe comprises the
inertial assembly, and the inertial assembly comprises a projection
from the elongate shaft. The projection can be constructed and
arranged to frictionally engage the rotatable optical core. The
projection can be constructed and arranged to cause shear force
that applies a load to the rotatable optical core during rotation.
The projection can be created by a thermal processing of the
elongate shaft.
[0071] In some embodiments, the imaging probe comprises the
inertial assembly, and the inertial assembly comprises a compressed
portion from the elongate shaft. The system can further comprise at
least one band configured to crimp the elongate shaft to create the
compressed portion.
[0072] In some embodiments, the imaging probe comprises the
inertial assembly, and the inertial assembly comprises the
impeller.
[0073] In some embodiments, the imaging probe comprises the
impeller, and the impeller is constructed and arranged to cause
wind-up loading of the rotatable optical core during rotation.
[0074] In some embodiments, the imaging probe comprises the
impeller and the imaging probe further comprises fluid in a lumen,
and the impeller is configured to engage the fluid during rotation
of the rotatable optical core.
[0075] In some embodiments, the imaging probe comprises the
impeller, and the impeller comprises a turbine.
[0076] In some embodiments, the imaging probe comprises the
impeller, and the impeller is configured to frictionally engage the
elongate shaft during rotation of the rotatable optical core.
[0077] In some embodiments, the imaging probe comprises the
impeller, and the impeller comprises a vane-type micro
structure.
[0078] In some embodiments, the imaging probe comprises the
impeller, and the impeller comprises a flywheel.
[0079] In some embodiments, the imaging probe comprises the
stiffening element.
[0080] In some embodiments, the imaging probe comprises the
stiffening element, and the stiffening element comprises a wire
coil embedded in the elongate shaft, and the wire spiral geometry
and a pullback spiral rotational pattern of the optical assembly
are matched but offset by approximately one-half of a wire spiral,
such that an imaging beam of the optical assembly passes between
the wire spirals during pullback.
[0081] In some embodiments, the imaging probe comprises the
stiffening element, and the stiffening element comprises a wound
wire formed over the rotatable optical core.
[0082] In some embodiments, the imaging probe comprises the
stiffening element, and the stiffening element comprises a
stiffening member embedded in the elongate shaft, and the
stiffening member geometry and a pullback spiral pattern of the
optical assembly are matched but offset by approximately one-half
of a wire spiral, such that an imaging beam of the optical assembly
passes between the wire spirals during pullback.
[0083] In some embodiments, the imaging probe comprises the reduced
portion of the elongate shaft. The imaging probe can comprise at
least one band crimped about the elongate shaft and constricting
the elongate shaft to create the reduced portion of the elongate
shaft. At least one band can provide a seal to be formed between
the rotatable core and the elongate shaft. The reduced portion of
the elongate shaft can comprise a thermally treated portion of the
elongate shaft.
[0084] In some embodiments, the imaging probe further comprises a
fluid positioned within the lumen of the elongate shaft. The fluid
can be configured to reduce variances in rotational speed of the
rotatable optical core. The system can further comprise a sealing
element positioned proximate the proximal end of the elongate
shaft, and the seal can be configured to maintain the fluid within
the lumen. The fluid can comprise a first fluid positioned around
the optical assembly and a second fluid positioned around the
rotatable optical core. The first fluid can comprise a first
viscosity and the second fluid can comprise a second viscosity
greater than the first viscosity. The second fluid can be
constructed and arranged to reduce variances in rotational speed of
the rotatable optical core. The system can further comprise a
sealing element positioned between the first fluid and the second
fluid. The fluid can comprise a gel. The fluid can comprise a
shear-thinning fluid. The fluid can comprise a shear-thinning gel.
The fluid can be configured to provide lubrication. The fluid can
be configured to cause the rotatable optical core to tend to remain
centered in the elongate shaft during rotation of the rotatable
optical core. The first fluid can comprise a viscosity between 10
Pa-S and 100,000 Pa-S. The first fluid can be configured to reduce
in viscosity to a level of approximately 3 Pa-S at a shear rate of
100 s-1. The fluid can comprise a lubricant configured to reduce
friction between the rotatable optical core and the elongate shaft.
The fluid can comprise a first fluid and a second fluid, and the
second fluid can be positioned within the elongate shaft proximate
the optical assembly, and the first fluid can be positioned within
the elongate shaft proximal to the second fluid. The imaging probe
can further comprise a sealing element in between the first fluid
and the second fluid. The sealing element can be positioned between
1 mm and 20 mm from the optical assembly. The sealing element can
be positioned approximately 3 mm from the optical assembly. The
first fluid can comprise a viscosity between 10 Pa-S and 100,000
Pa-S. The first fluid can comprise a shear-thinning fluid. The
first fluid can be configured to reduce in viscosity to a level of
approximately 3 Pa-S at a shear rate of 100 s-1. The first fluid
material can comprise a fluid selected from the group consisting
of: hydrocarbon-based material; silicone; and combinations thereof.
The second fluid can comprise a viscosity between 1 Pa-S and 100
Pa-S. The second fluid can comprise a viscosity of approximately 10
Pa-S. The second fluid can comprise a fluid selected from the group
consisting of: mineral oil; silicone; and combinations thereof. The
imaging system can be configured to pressurize the fluid in the
lumen. The imaging system can be constructed and arranged to
perform the pressurization of the fluid to reduce bubble formation
and/or bubble growth. The imaging system can be configured to
pressurize the fluid in the lumen to a pressure of at least 100
psi. The imaging system can comprise a pressurization assembly
configured to perform the pressurization of the fluid. The
pressurization assembly can comprise a check valve. The fluid can
comprise a lubricant. The lubricant can be configured to reduce
friction between the rotatable optical core and the elongate shaft
when at least a portion of the elongate shaft is positioned
proximate and distal to the carotid artery. The fluid can comprise
a high viscosity fluid. The elongate shaft can be constructed and
arranged to expand when the fluid is pressurized. The elongate
shaft can be constructed and arranged to expand to a first inner
diameter when the fluid is at a first pressure. The elongate shaft
can be constructed and arranged to expand to a second inner
diameter when the fluid is at a second pressure. The elongate shaft
can be constructed and arranged to become more rigid when the fluid
is pressurized. The elongate shaft can be constructed and arranged
to increase space between the rotatable optical core and the
elongate shaft during the expansion by the pressurized fluid. The
elongate shaft can be constructed and arranged to remain at least
partially expanded when the fluid pressure is reduced.
[0085] In some embodiments, the imaging probe further comprises a
torque shaft with a proximal end and a distal end, and the torque
shaft can be fixedly attached to the rotatable optical core such
that rotation of the torque shaft rotates the rotatable optical
core. The torque shaft can comprise stainless steel. The torque
shaft can comprise an outer diameter between 0.02'' and 0.09''. The
torque shaft can comprise an outer diameter of approximately
0.025''. The torque shaft can comprise a length of approximately 49
cm. The torque shaft can comprise a dimension selected from the
group consisting of: an inner diameter of approximately 0.015''; an
outer diameter of approximately 0.025''; and combinations thereof.
The torque shaft can comprise a wall thickness between 0.003'' and
0.020''. The torque shaft can comprise a wall thickness of
approximately 0.005''. The torque shaft distal end can be
positioned within 60 cm of the optical connector. The torque shaft
distal end can be positioned within 50 cm of the optical connector.
The torque shaft distal end can be positioned at least 50 cm from
the optical assembly. The torque shaft distal end can be positioned
at least 100 cm from the optical assembly. The imaging system can
further comprise a retraction assembly constructed and arranged to
retract at least one of the rotatable optical core or the elongate
shaft, and the torque shaft distal end can be positioned proximal
to the retraction assembly. The imaging probe can further comprise
a fixation tube positioned between the torque shaft and the
rotatable optical core. The fixation tube can be adhesively
attached to at least one of the torque shaft or the rotatable
optical core.
[0086] In some embodiments, the imaging system further comprises a
visualizable marker constructed and arranged to identify the
location of the optical assembly on a second image produced by a
separate imaging device. The separate imaging device can comprise a
device selected from the group consisting of: fluoroscope;
ultrasonic imager; MM; and combinations thereof. The visualizable
marker can be positioned on the optical assembly. The visualizable
marker can be positioned at a fixed distance from the optical
assembly. The imaging system can further comprise a connecting
element connecting the visualizable marker to the optical
assembly.
[0087] In some embodiments, the imaging probe can comprise multiple
markers constructed and arranged to provide a rule function. The at
least one of the multiple markers can comprise at least one of a
sealing element or a rotational dampener. The multiple markers can
comprise two or more markers selected from the group consisting of:
radiopaque marker; ultrasonically reflective marker; magnetic
marker; and combinations thereof. The multiple markers can be
positioned on the rotatable optical core. The multiple markers can
be positioned on the elongate shaft.
[0088] In some embodiments, the imaging system further comprises a
console comprising a component selected from the group consisting
of: rotation assembly; retraction assembly; imaging assembly;
algorithm; and combinations thereof.
[0089] In some embodiments, the imaging system further comprises a
rotation assembly constructed and arranged to rotate the rotatable
optical core. The rotation assembly can comprise a motor. The
imaging system can further comprise a retraction assembly
constructed and arranged to retract at least one of the rotatable
optical core or the elongate shaft. The imaging system can further
comprise a translatable slide, and the rotation assembly can be
positioned on the translatable slide. The rotation assembly can be
constructed and arranged to be positioned independent of the
position of the retraction assembly. The retraction assembly can be
constructed and arranged to be positioned closer to the patient
than the rotation assembly. The rotation assembly can provide
motive force to the retraction assembly. The rotation assembly can
comprise a drive cable that provides the motive force to the
retraction assembly. The elongate shaft can be constructed and
arranged to be retracted by the retraction assembly. The elongate
shaft can comprise a proximal portion constructed and arranged to
provide a service loop during retraction by the retraction
assembly. The rotation assembly can rotate the rotatable optical
core at a rate between 20 rps and 2500 rps. The rotation assembly
can rotate the rotatable optical core at a rate of approximately
250 rps. The rotation assembly can rotate the rotatable optical
core at a rate of up to 25,000 rps. The rotation assembly can be
constructed and arranged to rotate the rotatable optical core at a
variable rate of rotation. The imaging system can further comprise
a sensor configured to produce a signal, and the rotational rate
can be varied based on the sensor signal. The sensor signal
represents a parameter selected from the group consisting of:
tortuosity of vessel; narrowing of vessel; presence of clot;
presence of an implanted device; and combinations thereof. The
rotation assembly can be configured to allow an operator to vary
the rate of rotation. The rotation assembly can be configured to
automatically vary the rate of rotation. The rotation assembly can
be configured to increase the rate of rotation when collecting
image data from a target area.
[0090] In some embodiments, the imaging system further comprises a
retraction assembly constructed and arranged to retract at least
one of the rotatable optical core or the elongate shaft. The
retraction assembly can be constructed and arranged to retract the
rotatable optical core without retracting the elongate shaft. The
retraction assembly can be constructed and arranged to retract both
the rotatable optical core and the elongate shaft. The retraction
assembly can be constructed and arranged to retract the rotatable
optical core and the elongate shaft simultaneously. The retraction
assembly can be constructed and arranged to retract the rotatable
optical core and the elongate shaft in unison. The imaging probe
can comprise a fluid between the rotatable optical core and the
elongate shaft, and the retraction assembly can be constructed and
arranged to perform the retraction while minimizing bubble
formation in the fluid. The elongate shaft distal portion can
comprise an optically transparent window, and the optical assembly
can be positioned within the optically transparent window. The
optically transparent window can comprise a length of less than or
equal to 6 mm, less than or equal to 15 mm, or less than or equal
to 20 mm. The optically transparent window can comprise a length of
between 5 mm and 50 mm. The optically transparent window can
comprise a length of approximately 10 mm, or approximately 12 mm.
The optically transparent window can comprise a length of less than
or equal to 4 mm. The optically transparent window can comprise a
length of approximately 3 mm. The elongate shaft can comprise an
outer diameter less than or equal to 0.025''. The elongate shaft
can comprise an outer diameter less than or equal to 0.016''. The
elongate shaft can comprise an outer diameter less than or equal to
0.014''. The retraction assembly can be constructed and arranged to
retract the elongate shaft. The elongate shaft can comprise a
proximal portion constructed and arranged to provide a service loop
during retraction by the retraction assembly. The retraction
assembly can comprise a telescoping retraction assembly. The
telescoping retraction assembly can comprise a disposable motor.
The imaging probe can comprise a Tuohy valve and the retraction
assembly can operably engage the Tuohy valve during retraction. The
retraction assembly can be configured to perform a retraction over
a time period of between 0.1 seconds and 10 seconds. The retraction
assembly can be configured to perform a retraction over a time
period of approximately 4 seconds. The retraction assembly can be
constructed and arranged to retract the at least one of the
rotatable optical core or the elongate shaft over a distance of
approximately 50 mm. The retraction assembly can be constructed and
arranged to retract the at least one of the rotatable optical core
or the elongate shaft over a distance of approximately 75 mm. The
retraction assembly can be constructed and arranged to retract the
at least one of the rotatable optical core or the elongate shaft
over a distance of between 20 mm and 150 mm. The retraction
assembly can be constructed and arranged to have its retraction
distance selected by an operator of the system. The retraction
assembly can be configured to perform the retraction at a rate
between 3 mm/sec and 500 mm/sec. The retraction assembly can be
configured to perform the retraction at a rate of approximately 50
mm/sec. The retraction assembly can be constructed and arranged to
retract the at least one of the rotatable optical core or the
elongate shaft at a variable rate of retraction. The imaging system
can further comprise a sensor configured to produce a signal, and
the retraction rate can be varied based on the sensor signal. The
sensor signal can represent a parameter selected from the group
consisting of: tortuosity of vessel; narrowing of vessel; presence
of clot; presence of an implanted device; and combinations thereof.
The retraction assembly can be configured to allow an operator to
vary the retraction rate. The retraction assembly can be configured
to automatically vary the retraction rate. The retraction assembly
can be configured to decrease the rate of retraction when
visualizing a target area. The imaging system can further comprise
a catheter device comprising at least one of a vascular introducer
or a guide catheter, the elongate shaft insertable through the
catheter device, and the retraction assembly can be attachable to
the catheter device. The imaging system can further comprise a
catheter device comprising at least one of a vascular introducer or
a guide catheter, the elongate shaft insertable through the
catheter device, and the retraction assembly can be constructed and
arranged to be positioned within 20 cm from the catheter
device.
[0091] In some embodiments, the imaging system further comprises an
imaging assembly configured to provide light to the rotatable
optical core and to collect light from the rotatable optical core.
The imaging assembly can comprise a light source configured to
provide the light to the rotatable optical core. The imaging
assembly can comprise a fiber optic rotary joint comprising an
optical core configured to transmit light to the rotatable optical
core and receive light from the rotatable optical core. The
rotatable optical core can comprise a fiber with a first numerical
aperture, and the imaging assembly can comprise an imaging assembly
optical core with a second numerical aperture different than the
first numerical aperture. The first numerical aperture can be
approximately 0.16 and the second numerical aperture can be
approximately 0.11. The imaging system can further comprise an
adaptor configured to attach the imaging probe to the imaging
assembly. The adaptor can comprise a lens assembly configured to
match different numerical apertures. The adaptor can be configured
to be used in multiple clinical procedures, but in less procedures
than the imaging assembly. The adaptor can comprise a fiber with a
numerical aperture chosen to minimize coupling losses between the
imaging probe and the imaging assembly. The numerical aperture of
the adaptor fiber can be approximately equal to the geometrical
mean of the numerical aperture of the rotatable optical core and
the numerical aperture of the imaging assembly. The numerical
aperture of the adaptor fiber can be approximately equal to the
arithmetic mean of the numerical aperture of the rotatable optical
core and the numerical aperture of the imaging assembly.
[0092] In some embodiments, the imaging system further comprises an
algorithm. The imaging system can further comprise a sensor
configured to produce a signal, and the algorithm can be configured
to analyze the sensor signal. The sensor signal can represent light
collected from tissue. The sensor signal can represent a parameter
related to: tortuosity of a blood vessel; narrowing of a blood
vessel; presence of clot; presence of implanted device; and
combinations thereof.
[0093] In some embodiments, the imaging system further comprises at
least one guide catheter configured to slidingly receive the
imaging probe. The imaging system can further comprise a flushing
fluid delivery assembly configured to deliver a flushing fluid
between the at least one guide catheter and the imaging probe. The
flushing fluid can comprise saline and/or contrast (e.g. radiopaque
contrast). The flushing fluid delivery assembly can be configured
to deliver flushing fluid at a rate of approximately 6 ml/sec. The
imaging system can further comprise the flushing fluid, and the
flushing fluid can comprise iodinated contrast including an iodine
concentration between 50 mg/ml and 500 mg/ml. The flushing fluid
can comprise a fluid whose viscosity ranges from 1.0 Cp to 20 Cp at
a temperature of approximately 37.degree. C. The at least one guide
catheter can comprise a first guide catheter comprising an
optically transparent window, and the optical assembly can be
constructed and arranged to be positioned within the optically
transparent window. The first guide catheter can comprise a
microcatheter with an inner diameter between 0.021'' and 0.027''.
The first guide catheter can comprise a microcatheter with an inner
diameter between 0.0165'' and 0.027''. The at least one guide
catheter can further comprise a second guide catheter configured to
slidingly receive the first guide catheter.
[0094] In some embodiments, the imaging system further comprises a
torque tool constructed and arranged to operably engage the
elongate shaft and subsequently apply torsional force to the
elongate shaft.
[0095] According to another aspect of the present inventive
concepts, methods of using the imaging system described herein are
provided.
INCORPORATION BY REFERENCE
[0096] All publications, patents, and patent applications mentioned
in this specification are herein incorporated by reference to the
same extent as if each individual publication, patent, or patent
application was specifically and individually indicated to be
incorporated by reference.
BRIEF DESCRIPTION OF THE DRAWINGS
[0097] The foregoing and other objects, features and advantages of
embodiments of the present inventive concepts will be apparent from
the more particular description of preferred embodiments, as
illustrated in the accompanying drawings in which like reference
characters refer to the same or like elements. The drawings are not
necessarily to scale, emphasis instead being placed upon
illustrating the principles of the preferred embodiments.
[0098] FIG. 1 is a schematic view of an imaging system comprising
an imaging probe, an imaging console and one or more delivery
devices, consistent with the present inventive concepts.
[0099] FIG. 1A is magnified view of the distal portion of the shaft
of the imaging probe of FIG. 1, consistent with the present
inventive concepts.
[0100] FIG. 2 is a perspective view of an imaging probe comprising
a metal coil in a distal portion of its shaft, consistent with the
present inventive concepts.
[0101] FIG. 3 is a chart illustrating non-uniform rotational
distortion.
[0102] FIG. 4 is a side sectional view of the distal portion of an
imaging probe comprising a thin walled segment of shaft about an
optical assembly, consistent with the present inventive
concepts.
[0103] FIG. 5 is a side sectional view of the distal portion of an
imaging probe comprising two fluids within the shaft of the imaging
probe, consistent with the present inventive concepts.
[0104] FIG. 6 is a perspective view of an impeller, and a side
sectional view of a distal portion of an imaging probe comprising
the impeller, consistent with the present inventive concepts.
[0105] FIG. 7 is a side sectional view of a proximal portion of an
imaging probe comprising a pressurization element, consistent with
the present inventive concepts.
[0106] FIG. 8 is a side sectional anatomical view of a system
comprising a guide catheter, an imaging probe and a treatment
device, each of which having been placed into a vessel of the
patient, consistent with the present inventive concepts.
[0107] FIG. 9 is a side sectional anatomical view of the system of
FIG. 8, after the guide catheter has been partially retracted,
consistent with the present inventive concepts.
[0108] FIG. 10 is a side sectional anatomical view of the system of
FIG. 8, after the imaging probe has been advanced through the
treatment device, consistent with the present inventive
concepts.
[0109] FIG. 11 is a side sectional anatomical view of the system of
FIG. 8, as the imaging probe is being retracted through the
treatment device, consistent with the present inventive
concepts.
[0110] FIG. 12 is a side sectional anatomical view of a system
comprising an imaging probe and a treatment device, consistent with
the present inventive concepts.
[0111] FIG. 13 is a side sectional view of an imaging probe
comprising precision spacing between a rotatable optical core and a
shaft, the spacing configured to provide capillary action to a
fluid, consistent with the present inventive concepts.
[0112] FIG. 14 is partially assembled view of an imaging probe
comprising a shaft, rotatable optical core, and torque shaft,
consistent with the present inventive concepts.
[0113] FIG. 15A-C are side sectional views of an imaging probe in a
series of expansion steps of its shaft via an internal fluid,
consistent with the present inventive concepts.
[0114] FIG. 16 is a side sectional view of the distal portion of an
imaging probe comprising a distal marker positioned in reference to
an optical assembly, consistent with the present inventive
concepts.
[0115] FIG. 17 is a side sectional view of the distal portion of an
imaging probe comprising two sealing elements, consistent with the
present inventive concepts.
[0116] FIG. 18 is a side sectional view of the distal portion of an
imaging device comprising a lens and deflector separated and
connected by a projection, consistent with the present inventive
concepts.
DETAILED DESCRIPTION OF THE DRAWINGS
[0117] The terminology used herein is for the purpose of describing
particular embodiments and is not intended to be limiting of the
inventive concepts. Furthermore, embodiments of the present
inventive concepts may include several novel features, no single
one of which is solely responsible for its desirable attributes or
which is essential to practicing an inventive concept described
herein. As used herein, the singular forms "a," "an" and "the" are
intended to include the plural forms as well, unless the context
clearly indicates otherwise.
[0118] It will be further understood that the words "comprising"
(and any form of comprising, such as "comprise" and "comprises"),
"having" (and any form of having, such as "have" and "has"),
"including" (and any form of including, such as "includes" and
"include") or "containing" (and any form of containing, such as
"contains" and "contain") when used herein, specify the presence of
stated features, integers, steps, operations, elements, and/or
components, but do not preclude the presence or addition of one or
more other features, integers, steps, operations, elements,
components, and/or groups thereof.
[0119] It will be understood that, although the terms first,
second, third etc. may be used herein to describe various
limitations, elements, components, regions, layers and/or sections,
these limitations, elements, components, regions, layers and/or
sections should not be limited by these terms. These terms are only
used to distinguish one limitation, element, component, region,
layer or section from another limitation, element, component,
region, layer or section. Thus, a first limitation, element,
component, region, layer or section discussed below could be termed
a second limitation, element, component, region, layer or section
without departing from the teachings of the present
application.
[0120] It will be further understood that when an element is
referred to as being "on", "attached", "connected" or "coupled" to
another element, it can be directly on or above, or connected or
coupled to, the other element, or one or more intervening elements
can be present. In contrast, when an element is referred to as
being "directly on", "directly attached", "directly connected" or
"directly coupled" to another element, there are no intervening
elements present. Other words used to describe the relationship
between elements should be interpreted in a like fashion (e.g.,
"between" versus "directly between," "adjacent" versus "directly
adjacent," etc.).
[0121] It will be further understood that when a first element is
referred to as being "in", "on" and/or "within" a second element,
the first element can be positioned: within an internal space of
the second element, within a portion of the second element (e.g.
within a wall of the second element); positioned on an external
and/or internal surface of the second element; and combinations of
one or more of these.
[0122] Spatially relative terms, such as "beneath," "below,"
"lower," "above," "upper" and the like may be used to describe an
element and/or feature's relationship to another element(s) and/or
feature(s) as, for example, illustrated in the figures. It will be
understood that the spatially relative terms are intended to
encompass different orientations of the device in use and/or
operation in addition to the orientation depicted in the figures.
For example, if the device in a figure is turned over, elements
described as "below" and/or "beneath" other elements or features
would then be oriented "above" the other elements or features. The
device can be otherwise oriented (e.g., rotated 90 degrees or at
other orientations) and the spatially relative descriptors used
herein interpreted accordingly.
[0123] The term "and/or" where used herein is to be taken as
specific disclosure of each of the two specified features or
components with or without the other. For example "A and/or B" is
to be taken as specific disclosure of each of (i) A, (ii) B and
(iii) A and B, just as if each is set out individually herein.
[0124] As described herein, "room pressure" shall mean pressure of
the environment surrounding the systems and devices of the present
inventive concepts. Positive pressure includes pressure above room
pressure or simply a pressure that is greater than another
pressure, such as a positive differential pressure across a fluid
pathway component such as a valve. Negative pressure includes
pressure below room pressure or a pressure that is less than
another pressure, such as a negative differential pressure across a
fluid component pathway such as a valve. Negative pressure can
include a vacuum but does not imply a pressure below a vacuum. As
used herein, the term "vacuum" can be used to refer to a full or
partial vacuum, or any negative pressure as described
hereabove.
[0125] The term "diameter" where used herein to describe a
non-circular geometry is to be taken as the diameter of a
hypothetical circle approximating the geometry being described. For
example, when describing a cross section, such as the cross section
of a component, the term "diameter" shall be taken to represent the
diameter of a hypothetical circle with the same cross sectional
area as the cross section of the component being described. Shafts
of the present inventive concepts, such as hollow tube shafts
comprising a lumen and a wall, include an inner diameter (ID) equal
to the diameter of the lumen, and an outer diameter (OD) defined by
the outer surface of the shaft.
[0126] The terms "major axis" and "minor axis" of a component where
used herein are the length and diameter, respectively, of the
smallest volume hypothetical cylinder which can completely surround
the component.
[0127] The term "transducer" where used herein is to be taken to
include any component or combination of components that receives
energy or any input, and produces an output. For example, a
transducer can include an electrode that receives electrical
energy, and distributes the electrical energy to tissue (e.g. based
on the size of the electrode). In some configurations, a transducer
converts an electrical signal into any output, such light (e.g. a
transducer comprising a light emitting diode or light bulb), sound
(e.g. a transducer comprising a piezo crystal configured to deliver
ultrasound energy), pressure, heat energy, cryogenic energy,
chemical energy; mechanical energy (e.g. a transducer comprising a
motor or a solenoid), magnetic energy, and/or a different
electrical signal (e.g. a Bluetooth or other wireless communication
element). Alternatively or additionally, a transducer can convert a
physical quantity (e.g. variations in a physical quantity) into an
electrical signal. A transducer can include any component that
delivers energy and/or an agent to tissue, such as a transducer
configured to deliver one or more of: electrical energy to tissue
(e.g. a transducer comprising one or more electrodes); light energy
to tissue (e.g. a transducer comprising a laser, light emitting
diode and/or optical component such as a lens or prism); mechanical
energy to tissue (e.g. a transducer comprising a tissue
manipulating element); sound energy to tissue (e.g. a transducer
comprising a piezo crystal); chemical energy; electromagnetic
energy; magnetic energy; and combinations of one or more of
these.
[0128] As used herein, the term "patient site" refers to a location
within the patient, such as a location within a body conduit such
as a blood vessel (e.g. an artery or vein) or a segment of the GI
tract (e.g. the esophagus, stomach or intestine), or a location
with an organ. A "patient site" can refer to a location in the
spine, such as within the epidural space or intrathecal space of
the spine. A patient site can include a location including one or
more of: an aneurysm; a stenosis; thrombus and/or an implant.
[0129] As used herein, the term "neural site" refers to a patient
site proximate the brain, such as at a location within the neck,
head or brain of a patient. A neural site can include a location
proximate the brain including one or more of: an aneurysm; a
stenosis; thrombus and/or an implant.
[0130] As used herein, the term "proximate" shall include locations
relatively close to, on, in and/or within a referenced component or
other location.
[0131] As used herein, the term "transparent" and "optically
transparent" refer to a property of a material that is relatively
transparent (e.g. not opaque) to light delivered and/or collected
by one or more components of the imaging system or probe of the
present inventive concepts (e.g. to collect image data of a patient
site).
[0132] It is appreciated that certain features of the inventive
concepts, which are, for clarity, described in the context of
separate embodiments, may also be provided in combination in a
single embodiment. Conversely, various features of the inventive
concepts which are, for brevity, described in the context of a
single embodiment, may also be provided separately or in any
suitable sub-combination. For example, it will be appreciated that
all features set out in any of the claims (whether independent or
dependent) can be combined in any given way.
[0133] The present inventive concepts include imaging systems
comprising imaging probes and one or more delivery devices, such as
delivery catheters and/or guidewires. The imaging probe can be
configured to be positioned proximate a patient site and to collect
image data from the patient site, such as a neural site, spinal
site and/or other patient site as defined hereabove. The imaging
probe comprises an elongate shaft including a lumen. In some
embodiments, a rotatable optical core and a distally positioned
optical assembly are positioned within the lumen of the probe
shaft. A probe connector can be positioned on the proximal end of
the elongate shaft, the connector surrounding at least a portion of
the rotatable optical core (e.g. the proximal end of the rotatable
optical core). The present inventive concepts further includes
methods of introducing the imaging probe to a patient site, such as
a neural site, using one or more delivery devices such as delivery
catheters and/or guidewires. In some embodiments, the imaging probe
is advanced through a delivery catheter to a patient site, without
being advanced over a guidewire.
[0134] In some embodiments, the imaging probe comprises an inertial
assembly configured to reduce rotational speed variances of the
rotatable optical core. In some embodiments, the imaging probe
comprises an impeller attached to the rotatable optical core and
configured to resist rotation of the rotatable optical core, such
as when the rotatable optical core is retracted.
[0135] In some embodiments, the imaging probe comprises a
reinforcing assembly embedded into the elongate shaft. The
reinforcing assembly can be configured to resist flexing of the
elongate shaft and can comprise an optically transparent
portion.
[0136] In some embodiments, the imaging probe comprises an elongate
shaft in which at least a portion of the shaft includes a reduced
inner diameter or otherwise comprises a portion in which the gap
between the elongate shaft and the rotatable optical core is
reduced. The reduced gap portion can be configured to reduce
rotational speed variances of the rotatable optical core. In some
embodiments, the reduced gap portion causes the elongate shaft to
frictionally engage the rotatable optical core, providing a
dampening force configured to reduce undesired speed variances of
the rotatable optical core (e.g. to avoid undesired rotational
speed variances in the attached optical assembly 130).
Alternatively or additionally, a fluid can be positioned in the
reduced gap portion (or other locations between the elongate shaft
and the rotatable optical core), such as to similarly reduce
undesired speed variances of the rotatable optical core. The fluid
can comprise a shear-thinning fluid configured to avoid excessive
loading on the rotatable optical core (e.g. during high speed
rotation to prevent breaking of the rotatable optical core).
[0137] Systems, devices and methods of the present inventive
concepts can be used to diagnose and/or treat stroke. Stroke is the
4th-leading cause of death in the United States and leads all
ailments in associated disability costs. Stroke is a result of
vascular disease and comes in two major forms: ischemic, in which
the blood supply to the brain is interrupted; and hemorrhagic, in
which a ruptured vessel leaks blood directly in the brain tissue.
Both forms have associated high morbidity and mortality, such that
improved diagnosis and treatment would have a significant impact on
healthcare costs.
[0138] Imaging of the vessels is the primary diagnostic tool when
planning and applying therapies such as: thrombolytic drugs or
stent retrievers for clot removal (ischemic stroke); or coils, flow
diverters and other devices for aneurysm repair (hemorrhagic
stroke). External, non-invasive, imaging technologies, such as
x-ray, angiography or MRI, are the primary imaging techniques used,
but such techniques provide limited information such as vessel size
and shape information with moderate resolution (e.g. approximately
200 .mu.m resolution). Such levels of resolution do not permit the
imaging of important smaller perforator vessels present in the
vasculature. An inability to adequately image these vessels limits
pre-procedural planning as well as acute assessment of therapeutic
results. These imaging technologies are further limited in their
effectiveness due to the shadowing and local image obliteration
that can be created by the therapies themselves (e.g. in the case
of implantation of one or more coils). Thus there is a desire to
also perform intravascular imaging to examine the detailed
morphology of the interior vessel wall and/or to better plan and
assess the results of catheter based interventions. Currently,
intravascular imaging techniques such as Intravascular Ultrasound
(IVUS) and intravascular Optical Coherence Tomography (OCT) have
been developed, but are only approved for use in the coronary
arteries. IVUS is also used in the larger peripheral vasculature.
Currently, intravascular imaging has not been extended for use into
the neurological vessels except for the larger carotid arteries.
The limitations of current technologies correlate to: the
neurological vessel sizes can become very small, on the order of 1
mm in diameter or less, and the vessel tortuosity becomes quite
high (e.g. if attempting to navigate the tortuous carotid sinus to
reach and image the mid-cranial artery as well as branches and
segments above).
[0139] Due to the fundamental limits of ultrasound resolution,
especially the unavoidable beam spreading when small transducers
are used, optical techniques are more appropriate. In particular,
with the advent of new light sources such as broad band SLED's,
visible wavelength laser diodes, and compact swept-frequency light
sources, which are all compatible with single-mode fibers and
interferometric imaging such as OCT, the use of optical techniques
is highly advantageous both from a clinical performance as well as
commercial viewpoint. The use of single mode fibers allows small
diameter imaging catheters.
[0140] Referring now to FIG. 1, a schematic view of an imaging
system comprising an imaging probe and one or more delivery devices
is illustrated, consistent with the present inventive concepts.
System 10 is constructed and arranged to collect image data and
produce an image based on the recorded data, such as when system 10
comprises an Optical Coherence Tomogrophy (OCT) imaging system.
System 10 comprises imaging probe 100, and at least one delivery
device, such as at least one delivery catheter 50 and/or at least
one guidewire 60. System 10 can further comprise an imaging
console, console 200 which is configured to operably attach to
imaging probe 100. System 10 can further comprise a fluid injector,
such as injector 300 which can be configured to inject one or more
fluids, such as a flushing fluid, an imaging contrast agent (e.g. a
radiopaque contrast agent, hereinafter "contrast") and/or other
fluid, such as injectate 305 shown. System 10 can further comprise
an implant, such as implant 85 which can be implanted in the
patient via implant delivery device 80. System 10 can further
comprise a device configured to treat the patient, treatment device
91, which can be configured to dilate a stenotic site, remove
stenotic material (e.g. thrombus) and/or otherwise treat a patient
disease or disorder. System 10 can further comprise a second
imaging device, such as imaging device 92 shown.
[0141] Imaging probe 100 comprises an elongate shaft, shaft 110,
comprising proximal end 111, distal end 119, proximal portion 111a,
a middle portion (mid portion 115), and distal portion 119a. An
optical connector, connector 102 is positioned on the proximal end
111 of shaft 110, such as a connector configured to operably attach
probe 100 to console 200. Imaging probe 100 is configured to
provide a patient image, such as a three dimensional (3D) image
created when shaft 110 of imaging probe 100 is retracted. In some
embodiments, imaging probe 100 and/or another component of system
10 is of similar construction and arrangement to the similar
components described in applicant's co-pending U.S. Provisional
Application Ser. No. 62/148,355, titled "Micro-Optic Probes for
Neurology", filed Apr. 29, 2015, the content of which is
incorporated herein in its entirety for all purposes.
[0142] Imaging system 10 can comprise one or more imaging probes
100, each suitable for imaging highly tortuous bodily lumens such
as the mid-cranial artery, various peripheral arteries, and ducts
of the endocrine system such as the liver (bile) and pancreatic
ducts. Each imaging probe 100 can comprise very small
cross-sections, typically less than 1 mm in OD and contain a
rotatable optical core, core 120 comprising a single fiber
optically connected on its distal end to an optical assembly,
optical assembly 130. Core 120 is rotated to create a high fidelity
image of the luminal wall through which probe 100 is inserted.
Imaging probe 100 and other components of imaging system 10 can be
configured to facilitate uniform rotational velocity of core 120
while imaging probe 100 traverses difficult anatomies. Imaging
system 10 can comprise multiple imaging probes 100 provided in a
kit configuration, such as when two or more probes 100 comprise
different characteristics (e.g. different length, diameter and/or
flexibility)
[0143] Imaging probe 100 is constructed and arranged to collect
image data from a patient site. Distal portion 119a can be
configured to pass through the patient site, such as a patient site
including occlusive material such as thrombus or a patient site
including an implant. In some embodiments, probe 100 is constructed
and arranged to collect image data from a neural site, such as a
neural site selected from the group consisting of: artery of
patient's neck; vein of patient's neck; artery of patient's head;
vein of patient's head; artery of patient's brain; vein of
patient's brain; and combinations of one or more of these. In some
embodiments, probe 100 is constructed and arranged to collect image
data from one or more locations along or otherwise proximate the
patient's spine. In some embodiments, probe 100 is constructed and
arranged to collect image data from tissue selected from the group
consisting of: wall tissue of a blood vessel of the patient site;
thrombus proximate the patient site; occlusive matter proximate the
patient site; a blood vessel outside of blood vessel in which
optical assembly 130 is positioned; tissue outside of blood vessel
in which optical assembly 130 is positioned; extracellular deposits
outside of the lumen of the blood vessel in which optical assembly
130 is positioned (e.g. within and/or outside of the blood vessel
wall); and combinations of one or more of these. Alternatively or
additionally, optical assembly 130 can be constructed and arranged
to collect image data from an implanted device (e.g. a temporary or
chronically implanted device), such as implant 85 described
herebelow or a device previously implanted in the patient. In some
embodiments, optical assembly 130 is constructed and arranged to
collect image data regarding the placement procedure in which the
implant was positioned within the patient (e.g. real time data
collected during placement). Optical assembly 130 can be
constructed and arranged to collect implant data comprising
position and/or expansion data related to placement of an implant
or other treatment device, such as a device selected from the group
consisting of: a stent retriever (also known as a stentriever); an
embolization device such as an embolization coil; an embolization
coil delivery catheter; an occlusion device; a stent; a covered
stent; a stent delivery device; a flow diverter; an aneurysm
treatment device; an aneurysm delivery device; a balloon catheter;
and combinations of one or more of these. In some embodiments,
optical assembly 130 is constructed and arranged to collect data
related to the position of an implant 85 or other device comprising
a stimulation element, such as an electrode or other stimulation
element positioned proximate the brain (e.g. an electrode
positioned in the deep brain or other brain location) or a
stimulation element positioned proximate the spine (e.g.
stimulation element configured to treat pain by stimulating spine
tissue). Implantation of implant 85 can be performed based on an
analysis of collected image data (e.g. an analysis of collected
image data by algorithm 240). The analysis can be used to modify an
implantation parameter selected from the group consisting of:
selection of the implantable device (e.g. selection of implant 85);
selection of the implantable device porosity; selection of the
implantable device metal coverage; selection of the implantable
device pore density; selection of the implantable device diameter;
selection of the implantable device length; selection of the
location to implant the implantable device; a dilation parameter
for expanding the implantable device once implanted; a
repositioning of the implantable device once implanted; selection
of a second implantable device to be implanted; and combinations
thereof. An adjustment of the implantation can be performed based
on one or more issues identified in the analysis, such as an issue
selected from the group consisting of: malposition of implanted
device; inadequate deployment of implanted device; presence of air
bubbles; and combinations thereof.
[0144] In some embodiments, optical assembly 130 is constructed and
arranged to collect data related to the position of a treatment
device, such as treatment device 91 described herebelow, during a
patient treatment procedure.
[0145] Delivery catheters 50 can comprise one or more delivery
catheters, such as delivery catheters 50a, 50b, 50c through 50n
shown. Delivery catheters 50 can include a vascular introducer,
such as when delivery catheter 50a shown in FIG. 1 comprises a
vascular introducer, delivery catheter 50.sub.INTRO. Other delivery
catheters 50 can be inserted into the patient through delivery
catheter 50.sub.INTRO, after the vascular introducer is positioned
through the skin of the patient. Two or more delivery catheters 50
can collectively comprise sets of inner diameters (IDs) and outer
diameters (ODs) such that a first delivery catheter 50 slidingly
receives a second delivery catheter 50 (e.g. the second delivery
catheter OD is less than or equal to the first delivery catheter
ID), and the second delivery catheter 50 slidingly receives a third
delivery catheter 50 (e.g. the third delivery catheter OD is less
than or equal to the second delivery catheter ID), and so on. In
these configurations, the first delivery catheter 50 can be
advanced to a first anatomical location, the second delivery
catheter 50 can be advanced through the first delivery catheter to
a second anatomical location distal or otherwise remote
(hereinafter "distal") to the first anatomical location, and so on
as appropriate, using sequentially smaller diameter delivery
catheters 50.
[0146] Each delivery catheter 50 comprises a shaft 51 (e.g. shafts
51a, 51b, 51c and 51n shown), each with a distal end 59 (e.g.
distal ends 59a, 59b, 59c and 59n shown). A connector 55 (e.g.
connectors 55a, 55b, 55c and 55n shown) is positioned on the
proximal end of each shaft 51. Each connector 55 can comprise a
Touhy or other valved connector, such as a valved connector
configured to prevent fluid egress from the associated catheter 50
(with and/or without a separate shaft positioned within the
connector 55). Each connector 55 can comprise a port 54 as shown on
delivery catheters 50b, 50c, and 50n, such as a port constructed
and arranged to allow introduction of fluid into the associated
delivery catheter 50 and/or for removing fluids from an associated
delivery catheter 50. In some embodiments, a flushing fluid, as
described herebelow, is introduced via one or more ports 54, such
as to remove blood or other undesired material from locations
proximate optical assembly 130. Port 54 can be positioned on a side
of connector 55 and can include a luer fitting and a cap and/or
valve. Shafts 51, connectors 55 and ports 54 can each comprise
standard materials and be of similar construction to commercially
available introducers, guide catheters, diagnostic catheters,
intermediate catheters and microcatheters used in interventional
procedures.
[0147] Each delivery catheter 50 comprises a lumen 52 (reference
number 52 shown on delivery catheter 50a but removed from the
remaining delivery catheters 50 for illustrative clarity) extending
from the connector 55 to the distal end 59 of shaft 51. The
diameter of each lumen 52 defines the ID of the associated delivery
catheter 50. Each delivery catheter 50 can be advanced over a
guidewire (e.g. guidewire 60) via lumen 52. In some embodiments, a
delivery catheter 50 is configured for rapid exchange advancement
and retraction over a guidewire, such as via a sidecar with a rapid
exchange (Rx) guidewire lumen as is known to those of skill in the
art. In some embodiments, probe 100 and at least one delivery
catheter 50 are cooperatively constructed and arranged such that
the delivery catheter 50 is advanced through a vessel, such as a
blood vessel, and probe 100 is slidingly received by the delivery
catheter 50 and advanced through the delivery catheter 50 to a
location proximate a patient site PS to be imaged (e.g. a location
just distal to, within and/or just proximate the patient site PS to
be imaged). In some embodiments, a second delivery catheter 50 is
slidingly received by a first delivery catheter 50, and probe 100
is advanced through the second delivery catheter 50 to a location
proximate a patient site PS to be imaged. In yet other embodiments,
three or more delivery catheters 50 are coaxially inserted in each
other, with probe 100 advanced through the innermost delivery
catheter 50 to a location proximate a patient site PS to be imaged.
In some embodiments, probe 100 is advanced through (e.g. through
and beyond) one or more delivery catheters 50 without the use of a
guidewire.
[0148] Delivery catheters 50 can comprise one or more delivery
catheters selected from the group consisting of: an introducer; a
vascular introducer; an introducer with an ID between 7 Fr and 9
Fr; a delivery catheter (also referred to as a guide catheter) for
positioning through the aortic arch (e.g. such that its distal end
is just distal or otherwise proximate the aortic arch) such as a
delivery catheter with an ID between 5 Fr and 7 Fr or an ID of
approximately 6.5 Fr; a delivery catheter (also referred to as an
intermediate catheter) for insertion through a larger, previously
placed delivery catheter, such as an intermediate delivery catheter
with an ID of between 0.053'' and 0.070''; a delivery catheter
(also referred to as a microcatheter) with an ID of between
0.0165'' and 0.027''; and combinations of one or more of these. In
some embodiments, delivery catheters 50 comprise a first delivery
catheter 50.sub.INTRO comprising an introducer, such as an
introducer with an ID of between 7 Fr and 9 Fr or an ID of
approximately 8 Fr. Delivery catheters 50 further can further
comprise a second delivery catheter 50 constructed and arranged to
be inserted into the first delivery catheter 50, such as a second
delivery catheter 50.sub.GUIDE constructed and arranged for
positioning through the aortic arch and comprising an ID between 5
Fr and 7 Fr or an ID of approximately 6 Fr. Delivery catheters 50
can comprise a third delivery catheter 50 constructed and arranged
to be inserted through the first delivery catheter 50.sub.INTRO
and/or the second delivery catheter 50.sub.GUIDE, such as a third
delivery catheter 50.sub.INTER (e.g. an intermediate catheter) with
an ID of between 0.053'' and 0.070''. Delivery catheters 50 can
comprise a fourth delivery catheter 50.sub.MICRO constructed and
arranged to be inserted through the first, second and/or third
delivery catheters 50, such as a fourth delivery catheter
50.sub.MICRO with an ID of between 0.0165'' to 0.027''. Imaging
probe 100 can be constructed and arranged to be inserted through
first, second, third and/or fourth delivery catheters 50, such as
when imaging probe 100 comprises an OD of less than 0.070'', such
as when at least the distal portion of imaging probe 100 comprises
an OD of less than or equal to 0.025'', 0.022'', 0.018'', 0.016'',
0.015'' or 0.014''. In some embodiments, at least the distal
portion of imaging probe 100 comprises an ID of approximately
0.014'' (e.g. an ID between 0.012'' and 0.016''). In some
embodiments, system 10 comprises a probe 100 and one or more
delivery catheters 50.
[0149] Each delivery catheter 50 can comprise an optically
transparent segment, such as a segment relatively transparent to
light transmitted and/or received by optical assembly 130, such as
transparent segment 57 shown on delivery catheter 50n and described
herein. Transparent segment 57 can comprise a length of up to 50
cm, such as a length of between 1 cm and 15 cm, or a length of up
to 2 cm or up to 5 cm. Transparent segment 57 can be part of a
delivery catheter 50 comprising a microcatheter with an ID between
0.0165'' and 0.027'', or between 0.021'' and 0.027''. System 10 can
comprise a first delivery catheter 50 that slidingly receives probe
100 and includes a transparent segment 57, and a second delivery
catheter 50 that slidingly receives the first delivery catheter
50.
[0150] Each delivery catheter 50 can comprise a spring tip, not
shown but such as spring tip 104 described herein as attached to
shaft 110 of probe 100.
[0151] Guidewires 60 can comprise one or more guidewires, such as
guidewires 60a, 60b through 60n shown. Guidewires 60 can comprise
one or more guidewires constructed and arranged to support
advancement (e.g. intravascular advancement) of probe 100 (e.g. via
a rapid exchange lumen in distal portion 119a of shaft 110) and/or
a delivery catheter 50 into a patient site PS such as a neural
site. Guidewires 60 can comprise one or more guidewires selected
from the group consisting of: a guidewire with an OD between
0.035'' and 0.038''; a guidewire with an OD between 0.010'' and
0.018''; an access length guidewire such as a guidewire with a
length of approximately 200 cm; an exchange length guidewire such
as a guidewire with a length of approximately 300 cm; a guidewire
with a length between 175 cm and 190 cm; a guidewire with a length
between 200 cm and 300 cm and/or an OD between 0.014'' and 0.016'';
a hydrophilic guidewire; a Stryker Synchro.TM. guidewire; a Terumo
guidewire such as the Terumo Glidewire.TM. guidewire; a Terumo
Traxcess.TM. guidewire; an X-Celerator.TM. guidewire; an
X-Pedion.TM. guidewire; an Agility.TM. guidewire; a Bentson.TM.
guidewire; a Coon.TM. guidewire; an Amplatz.TM. guidewire; and
combinations of one or more of these. In some embodiments, system
10 comprises a probe 100 and one or more guidewires 60. Guidewires
60 can comprise one or more visualizable portions, such as one or
more radiopaque or ultrasonically reflective portions.
[0152] System 10 can comprise various sets and configurations of
delivery catheters 50 and guidewires 60. In some embodiments,
delivery catheters 50 comprise a first delivery catheter
50.sub.INTRO comprising an introducer (e.g. a vascular introducer),
and at least two delivery catheters 50 that are inserted through
delivery catheter 50.sub.INTRO, these catheters comprising
corresponding different sets of IDs and ODs, such as to allow
sequential insertion of each delivery catheter 50 through the lumen
52 of a previously placed delivery catheter 50, as described in
detail herein. In some embodiments, a first delivery catheter 50 is
advanced over a first guidewire 60, and a smaller OD delivery
catheter 50 is subsequently advanced over a smaller OD guidewire 60
(e.g. after the first guidewire 60 is removed from the first
delivery catheter 50 and replaced with the second guidewire 60). In
some embodiments, after image data is collected by an imaging probe
100 positioned within a delivery catheter (e.g. after a retraction
in which the image data is collected), imaging probe 100 is removed
and replaced with a guidewire 60 over which an additional device
can be placed (e.g. another delivery catheter 50, a treatment
device 91, an implant delivery device 80 or other device). In some
embodiments, probe 100, one or more delivery catheters 50 and/or
one or more guidewires 60 are inserted, advanced and/or retracted
as described herein.
[0153] Probe 100, one or more delivery catheters 50 and/or one or
more guidewires 60 can be advanced to a patient site PS through one
or more blood vessels (e.g. advancement of or more delivery
catheters 50 over a guidewire 60 through one or more arteries or
veins). Alternatively or additionally, probe 100, one or more
delivery catheters 50 and/or one or more guidewires 60 can be
advanced to a patient site PS via a non-blood vessel lumen, such as
the epidural and/or intrathecal space of the spine, or via another
body lumen or space (e.g. also as can be performed over a guidewire
60).
[0154] In some embodiments, one or more delivery catheters 50
comprise a functional element 53 (e.g. functional elements 53a,
53b, 53c and 53n shown). Each functional element 53 can comprise
one or more functional elements such as one or more sensors,
transducers and/or other functional elements as described in detail
herebelow. In some embodiments, shaft 110 comprises a length of at
least 100 cm, at least 200 cm, at least 240 cm. In some
embodiments, shaft 110 comprises a length of approximately 250 cm.
In some embodiments, shaft 110 comprises a length less than or
equal to 350 cm, less than or equal to 250 cm, or less than or
equal to 220 cm.
[0155] In some embodiments, shaft 110 comprises an outer diameter
(OD) between 0.005'' and 0.022'' along at least a portion of its
length (e.g. at least a portion of distal portion 119a). In some
embodiments, shaft 110 comprises an OD of approximately 0.0134'',
an OD at or below 0.014'' or an OD at or below 0.016'', along at
least a portion of its length (e.g. along a portion surrounding
core 120 and/or optical assembly 130, and/or along at least the
most distal 10 cm, 20 cm or 30 cm of shaft 110). In these
embodiments, imaging probe 100 can be configured to be advanced
and/or retracted without a guidewire or delivery catheter (e.g.
when optical assembly 130 and shaft 110 are retracted in unison
during collection of image data). In some embodiments, shaft 110
comprises an OD that is less than 1 mm, or less than 500 .mu.m,
along at least a portion of its length. In some embodiments, shaft
110 comprises an OD that changes along its length. In some
embodiments, distal portion 119a comprises a larger OD than an OD
of mid portion 115, such as when the portion of distal portion 119a
surrounding optical assembly 130 has a larger OD than an OD of
mid-portion 115. In these embodiments, distal portion 119a can
comprise a larger or similar ID as an ID of mid portion 115.
[0156] In some embodiments, shaft 110 comprises an inner diameter
(ID) between 0.004'' and 0.012'', along at least a portion of its
length. In some embodiments, shaft 110 comprises an ID of
approximately 0.0074'' along at least a portion of its length (e.g.
along a portion surrounding core 120 and/or optical assembly 130).
In some embodiments, shaft 110 comprises an ID that changes along
its length. In some embodiments, distal portion 119a comprises a
larger ID than an ID of mid portion 115, such as when the portion
of distal portion 119a surrounding optical assembly 130 has a
larger ID than an ID of mid-portion 115.
[0157] In some embodiments, shaft 110 comprises a wall thickness of
0.001'' to 0.005'', or a wall thickness of approximately 0.003'',
along at least a portion of its length (e.g. along a portion
surrounding core 120 and/or optical assembly 130. In some
embodiments, shaft 110 comprises a thinner wall surrounding at
least a portion of optical assembly 130 (e.g. thinner than a
portion of the wall surrounding core 120).
[0158] In some embodiments, shaft 110 distal portion 119a has a
larger ID than mid portion 115 of shaft 110, such as when mid
portion 115 has an ID at least 0.002'' larger than the ID of distal
portion 119a. In these embodiments, the OD of mid portion 115 and
the OD of distal portion 119a can be of similar magnitude.
Alternatively, the OD of mid portion 115 can be different than the
OD of distal portion 119a (e.g. the OD of distal portion 119a can
be greater than the OD of mid portion 115, such as when distal
portion 119a is at least 0.001'' larger).
[0159] In some embodiments, imaging probe 100 comprises a stiffened
portion, such as when imaging probe 100 comprises stiffening
element 118. Stiffening element 118 is positioned in, within and/or
along at least a portion of shaft 110. In some embodiments,
stiffening element 118 is positioned within or on the inside
surface of the wall of shaft 110. In some embodiments, stiffening
element 118 comprises a wire wound over core 120. In some
embodiments, stiffening element 118 terminates proximal to optical
assembly 130. Alternatively, stiffening element 118 can travel
lateral to and/or potentially beyond optical assembly 130, such as
when the portion of stiffening element 118 comprises one or more
optically transparent materials.
[0160] In some embodiments, distal portion 119a comprises a wall
thickness that is less than the wall thickness of mid portion 115.
In some embodiments, distal portion 119a comprises a stiffer
material than the materials of mid portion 115, and/or distal
portion 119a includes a stiffening element (e.g. stiffening element
118a shown in FIG. 13 herebelow), such as when distal portion 119a
comprises a wall thickness less than the wall thickness of mid
portion 115.
[0161] In some embodiments, probe 100 comprises a guidewire lumen,
such as a rapid exchange guidewire lumen positioned in a sidecar
105 shown in FIG. 1. Sidecar 105 can comprise a length of less than
150 mm. Sidecar 105 can comprise a length of at least 15 mm, such
as a length of approximately 25 mm.
[0162] In some embodiments, proximal portion 111a of shaft 110 is
configured to be positioned in a service loop. Shaft 110 proximal
portion 111a can comprise a different construction than mid portion
115 or different than distal portion 119a. For example, proximal
portion 111a can comprise a larger OD than mid portion 115 or a
thicker wall than mid portion 115.
[0163] In some embodiments, shaft 110 comprises an outer shaft and
an inner "torque" shaft, which can be shorter than the outer shaft,
such as is described herebelow in reference to FIG. 14. In some
embodiments, the torque shaft terminates prior to a portion of
probe 100 that enters the patient.
[0164] In some embodiments, system 10 comprises torque tool 320, a
tool that frictionally engages shaft 110 of probe 100 (e.g. from a
lateral direction at a location along proximal portion 111a), and
allows an operator to apply torsional force to shaft 110.
[0165] Referring additionally to FIG. 1A, a magnified view of
distal portion 119a is illustrated, consistent with the present
inventive concepts. A lumen 112 extends from proximal end 111 of
shaft 110 to distal portion 119a, ending at a location proximal to
distal end 119. Positioned within lumen 112 is a rotatable optical
core, core 120. An optical assembly, optical assembly 130 is
positioned on the distal end of core 120. Optical assembly 130
includes lens 131, and a reflecting surface, reflector 132. Optical
assembly 130 is positioned within an optically translucent and/or
effectively transparent window portion of shaft 110, viewing
portion 117. Optical assembly 130 is constructed and arranged to
collect image data through at least a portion of shaft 110. In some
embodiments, optical assembly 130 is further constructed and
arranged to collect image data through at least a portion of an
additional device, such as at least a portion of a shaft of a
delivery catheter 50 (e.g. an optically transparent portion of a
delivery catheter 50, such as transparent segment 57 described
herein). In FIG. 1A, optional components sidecar 105 and stiffening
element 118 have been removed for illustrative clarity.
[0166] In some embodiments, a fluid 190 is included in lumen 112
(e.g. in the space not occupied by core 120 and optical assembly
130), such as fluid 190a and fluid 190b shown in FIG. 1A where
fluid 190b is positioned around optical assembly 130, and fluid
190a is positioned around core 120 proximal to optical assembly
130. Fluid 190 (e.g. fluid 190b) can comprise an optically
transparent fluid. In some embodiments, fluid 190a and fluid 190b
comprise similar materials. Alternatively or additionally, fluid
190a and fluid 190b can comprise dissimilar materials. In some
embodiments, fluid 190a comprises a more viscous fluid than fluid
190b. Fluid 190a and/or 190b (singly or collectively fluid 190) can
be constructed and arranged to limit undesired variations in
rotational velocity of core 120 and/or optical assembly 130. In
some embodiments, fluid 190 comprises a gel. In some embodiments,
fluid 190 comprises a non-Newtonian fluid (e.g. a shear-thinning
fluid) or other fluid whose viscosity changes with shear.
Alternatively or additionally, fluid 190 can comprise a lubricant
(e.g. to provide lubrication between core 120 and shaft 110). In
some embodiments, fluid 190 comprises a shear-thinning fluid, and
core 120 is rotated at a rate above 50 Hz, such as a rate above 100
Hz or 200 Hz. At higher rotation rates, if fluid 190 comprised a
high viscosity Newtonian fluid, the resultant viscous drag during
rotation of core 120 would result in a torsional load on core 120
which would cause it to break before the high rotation could be
reached. However, a fluid 190 comprising a low viscosity Newtonian
fluid is also not desired, as it would not provide sufficient
dampening (e.g. would not provide adequate rotational speed
control), such as during low-speed ("idle-mode`) imaging. For these
reasons, probe 100 can comprise a fluid 190 that is a relatively
high viscosity, shear-thinning (non-Newtonian) fluid, that provides
sufficient loading during low speed rotation of core 120 and, due
to its varying viscosity, avoid excessive loading during high speed
rotation of core 120. In some embodiments, fluid 190 comprises a
shear-thinning fluid whose viscosity changes non-linearly (e.g. its
viscosity rapidly decreases with increasing shear rate). In some
embodiments, probe 100 comprises a reduced gap between shaft 110
and core 120 along at least a portion of shaft 110 (e.g. a portion
of shaft 110 proximal to optical assembly 130), such as via a space
reducing element as described herebelow in reference to FIG. 16.
This gap can range from 20 .mu.m to 200 .mu.m (e.g. a constant or
varied gap between 20 .mu.m and 200 .mu.m). Fluid 190 (e.g. a high
viscosity, shear-thinning fluid) can be positioned (at least) in
the reduced gap portion of shaft 110. In this configuration, the
amount of force applied to core 120 to reduce rotational variation
is proportional to the shear stress and the length of shaft 110 in
which fluid 190 and shaft 110 interact (the "interaction length").
Positioning of this interaction length relatively proximate to
optical assembly 130 optimizes reduction of undesired rotational
velocity variation of optical assembly 130 (e.g. since core 120 can
have low torsional rigidity, dampening sufficiently far from
optical assembly 130 will not provide the desired effect upon
optical assembly 130).
[0167] In some embodiments, optical assembly 130 comprises a lens
131 with an OD that is greater than the diameter of lumen 112 of
shaft 110 (e.g. greater than the diameter of at least a portion of
lumen 112 that is proximal to optical assembly 130). The OD of lens
131 being greater than the diameter of lumen 112 prevents optical
assembly 130 from translating within lumen 112. For example, lens
131 can comprise a relatively large diameter aperture lens, such as
to provide a small spot size while collecting large amounts of
light (e.g. a lens 131 with an OD approaching up to 350 .mu.m).
Lumen 112 can be less than this diameter (e.g. less than 350
.mu.m), such as to allow a reduced OD of shaft 110 proximal to
optical assembly 130 (e.g. as shown in FIGS. 4, 5, 6, 12, 13 and
16). In embodiments in which the OD of optical assembly 130 is
greater than the diameter of lumen 112 at locations proximal to
optical assembly 130, the portion of shaft 110 surrounding optical
assembly 130 has a larger OD and/or ID than the portions of shaft
110 proximal to optical assembly 130. In these embodiments, both
shaft 110 and optical assembly 130 are retracted simultaneously
during collection of image data, since lumen 112 has too small a
diameter to accommodate translation of optical assembly 130.
[0168] In some embodiments, fluid 190 (e.g. fluid 190a) comprises a
fluid with a viscosity between 10 Pa-S and 100,000 Pa-S. In these
embodiments, fluid 190 can be configured to thin to approximately 3
Pa-S at a shear rate of approximately 100 s.sup.-1. In some
embodiments, fluid 190 (e.g. fluid 190b) comprises a viscosity
between 1 Pa-S and 100 Pa-S, such as a viscosity of approximately
10 Pa-S. In some embodiments, fluid 190 is configured to cause core
120 to tend to remain centered within lumen 112 of shaft 110 as it
rotates (e.g. due to the shear-thinning nature of fluid 190). In
some embodiments, fluid 190a comprises a hydrocarbon-based material
and/or silicone. In some embodiments, fluid 190b comprises mineral
oil and/or silicone. In some embodiments, probe 100 includes one or
more fluids 190 in at least the most distal 20 cm of shaft 110.
[0169] In some embodiments, a seal is included in lumen 112,
sealing element 116, constructed and arranged to provide a seal
between core 120 and the walls of shaft 110 (e.g. when positioned
within distal portion 119a). Sealing element 116 can allow for the
rotation of core 120, while preventing the mixing and/or migrating
of fluids 190a and/or 190b (e.g. by resisting the flow of either
around seal 116). In some embodiments, a sealing element 116 is
positioned between 1 mm and 200 from optical assembly 130, such as
when sealing element 116 is positioned approximately 3 mm from
optical assembly 130. In some embodiments, sealing element 116
comprises two or more sealing elements, such as two or more sealing
elements 116 which slidingly engage core 120 and/or optical
assembly 130. In some embodiments, probe 100 comprises a sealing
element positioned in a proximal portion of shaft 110 (e.g. within
or proximate connector 102), such as sealing element 151 described
herebelow in reference to FIG. 7.
[0170] Sealing element 116 and/or 151 can comprise an element
selected from the group consisting of: a hydrogel material; a
compliant material; silicone; and combinations of one or more of
these. In some embodiments, sealing element 116 and/or 151 can
comprise a material bonded to shaft 110 with an adhesive, or simply
an adhesive itself on shaft 110 (e.g. a UV cured adhesive or an
adhesive configured not to bond with core 120).
[0171] In some embodiments, fluid 190 is configured to be
pressurized, such as is described herein in reference to FIG. 7,
such as to reduce bubble formation and/or bubble growth within
fluid 190.
[0172] Shaft 110 can comprise one or more materials, and can
comprise at least a portion which is braided and/or includes one or
more liners, such as a polyimide or PTFE liner. In some
embodiments, at least the distal portion 119a of shaft 110
comprises an OD less than or equal to 0.025'', such as an OD less
than or equal to 0.022'', 0.018'', 0.016'', 0.015'' or 0.014''. In
some embodiments, shaft 110 comprises a material selected from the
group consisting of: polyether ether ketone (PEEK); polyimide;
nylon; fluorinated ethylene propylene (FEP);
polytetrafluoroethylene (PTFE); polyether block amide (Pebax); and
combinations of one or more of these. In some embodiments, shaft
110 comprises at least a portion including a braid including
stainless steel and/or a nickel titanium alloy, such as a shaft 110
including a braid positioned over thin walled FEP or PTF. The
braided portion can be coated with Pebax or other flexible
material. In some embodiments, shaft 110 comprises at least a
portion (e.g. a proximal portion) that is metal, such as a metal
hypotube comprising stainless steel and/or nickel titanium alloy.
In some embodiments, shaft 110 comprises a first portion that is a
metal tube, and a second portion, distal to the first portion, that
comprises a braided shaft. In some embodiments, shaft 110 comprises
at least a portion that comprises a hydrophobic material or other
material configured to reduce changes (e.g. changes in length) when
exposed to a fluid.
[0173] Viewing portion 117 of shaft 110 can comprise one or more
materials, and can comprise similar or dissimilar materials to a
different portion of shaft 110. Viewing portion 117 can comprise a
similar ID and/or OD as one or more other portions of shaft 110. In
some embodiments, viewing portion 117 comprises an ID and/or OD
that is larger than an ID and/or OD of shaft 110 at mid portion 115
of shaft 110. Viewing portion 117 can comprise a similar or
dissimilar flexibility as one or more other portions of shaft 110.
Viewing portion 117 can comprise one or more optically transparent
materials selected from the group consisting of: Pebax; Pebax 7233;
PEEK; amorphous PEEK; polyimide; glass; sapphire; nylon 12; nylon
66; and combinations of one or more of these.
[0174] In some embodiments, a flexible tip portion is positioned on
the distal end of shaft 110, such as spring tip 104 shown. Spring
tip 104 can comprise a length of between 0.5 cm and 5 cm, such as a
length of approximately lcm, 2 cm or 3 cm, or a length between 2 cm
and 3 cm. At least a portion of spring tip 104 can be made visible
to an imaging apparatus, such as by including a radiopaque material
such as platinum or other material visible to an X-ray imaging
device. Spring tip 104 can comprise a core comprising a material
such as stainless steel.
[0175] In some embodiments, probe 100 and/or other components of
system 10 comprise one or more markers (e.g. radiopaque or other
visualizable markers), sensors, transducers or other functional
elements such as: functional elements 53a-n of delivery catheters
50; functional element 83 of implant delivery device 80; functional
element 93 of treatment device 91; functional elements 113a and
113b (singly or collectively functional element 113, described
herebelow) of shaft 110; functional element 123 of core 120;
functional element 133 of optical assembly 130; functional element
203 of console 200; and functional element 303 of injector 300.
[0176] In some embodiments, core 120 comprises a single mode glass
fiber, such as a fiber with an OD between 40 .mu.m and 175 .mu.m, a
fiber with an OD between 80 .mu.m and 125 .mu.m, a fiber with an OD
between 60 .mu.m and 175 .mu.m, or a fiber with an OD of
approximately 110 .mu.m. Core 120 can comprise a material selected
from the group consisting of: silica glass; plastic; polycarbonate;
and combinations of one or more of these. Core 120 can comprise a
fiber with a coating, such as a polyimide coating. Core 120 can
comprise cladding material and/or coatings surrounding the fiber,
such as are known to those of skill in the art. Core 120 can
comprise a numerical aperture (NA) of at or above 0.11, such as an
NA of approximately 0.16 or 0.20. In some embodiments, core 120 can
comprise an NA (e.g. an NDA between 0.16 and 0.20) to significantly
reduce bend-induced losses, such as would be encountered in
tortuous anatomy. System 10 can be configured to rotate core 120 in
a single direction (uni-directional rotation) or multi-directional
(bi-directional rotation).
[0177] In some embodiments, probe 100 and other components of
system 10 are configured to retract core 120 within shaft 110. In
these embodiments, probe 100 can be configured such that a material
(e.g. fluid 190) is introduced into and within shaft 110 (e.g.
between core 120 and shaft 110). The introduced material can be
configured to provide a function selected from the group consisting
of: index matching; lubrication; purging of bubbles; and
combinations of one or more of these.
[0178] In some embodiments, optical assembly 130 comprises an OD
between 80 .mu.m and 500 .mu.m, such as an OD of at least 125
.mu.m, or an OD of approximately 150 .mu.m. In some embodiments,
optical assembly 130 comprises a length of between 200 .mu.m and
3000 .mu.m, such as a length of approximately 1000 .mu.m. Optical
assembly 130 can comprise one or more lenses, such as lens 131
shown, such as a GRIN lens and/or a ball lens. Optical assembly 130
can comprise a GRIN lens with a focal length between 0.5 mm and
10.0 mm, such as approximately 2.0 mm. Optical assembly 130 can
comprise one or more reflecting elements, such as reflecting
element 132 shown.
[0179] In some embodiments, optical assembly 130 comprises a lens
131 and a reflecting element 132 which is positioned offset from
lens 131 via one or more connecting elements 137 as shown in FIG.
18. Connecting element 137 can comprise a tube (e.g. a heat shrink
tube) surrounding at least a portion of lens 131 and reflecting
element 132. Connecting element 137 can comprise one or more
elements selected from the group consisting of: tube; flexible
tube; heat shrink; optically transparent arm; and combinations of
one or more of these. Connecting element 137 can position
reflecting element 132 at a distance of between 0.01 mm and 3.0 mm
from lens 131, such as at a distance between 0.01 mm and 1.0 mm.
Reflecting element 132 can comprise a partial portion of a larger
assembly that is cut or otherwise separated (e.g. cleaved) from the
larger assembly during a manufacturing process used to fabricate
optical assembly 130. Use of the larger assembly can simplify
handling during manufacturing. In some embodiments, the resultant
reflecting element 132 comprises a shape-optimized reflector.
Reflecting element 132 can comprise a segment of wire, such as a
gold wire. In these embodiments, lens 131 can comprise a GRIN lens,
such as a lens with an OD of approximately 150 .mu.m and/or a
length of approximately 1000 .mu.m. In some embodiments, lens 131
further comprises a second lens, such as a coreless lens positioned
proximal to and optically connected to the GRIN lens.
[0180] In some embodiments, imaging probe 100 comprises a reduced
diameter portion (e.g. a reduced outer and/or inner diameter
portion) along shaft 110, at a location proximal to optical
assembly 130, such as is shown in FIGS. 4, 5, 6, 12, 13 and 16. In
these embodiments, optical assembly 130 can comprise an OD that is
larger than lumen 112 of shaft 110 (e.g. at a location proximal to
optical assembly 130), such as to provide a larger lens 131 for
improved imaging capability. In some embodiments, probe 100
comprises a space reducing element between shaft 110 and core 120,
such as is described herebelow in reference to elements 122 of FIG.
16. Functional elements 113 and/or 123 can comprise a space
reducing element (e.g. a projection from shaft 110 and/or core 120,
respectively).
[0181] Console 200 can comprise an assembly, rotation assembly 210
constructed and arranged to rotate at least core 120. Rotation
assembly 210 can comprise one or more motors configured to provide
the rotation, such as a motor selected from the group consisting
of: DC motor; AC motor; stepper motor; synchronous motor; and
combinations of one or more of these. Console 200 can comprise an
assembly, retraction assembly 220, constructed and arranged to
retract at least shaft 110. Retraction assembly 220 can comprise
one or more motors or linear drive elements configured to provide
the retraction, such as a component selected from the group
consisting of: DC motor; AC motor; stepper motor; synchronous
motor; gear mechanism, linear drive mechanism; magnetic drive
mechanism; piston; pneumatic drive mechanism; hydraulic drive
mechanism; and combinations of one or more of these. Rotation
assembly 210 and/or retraction assembly 220 can be of similar
construction and arrangement to those described in applicant's
co-pending application U.S. Provisional Application Ser. No.
62/148,355, titled "Micro-Optic Probes for Neurology", filed Apr.
29, 2015; the content of which is incorporated herein by reference
in its entirety for all purposes.
[0182] Console 200 can comprise an imaging assembly 230 configured
to provide light to optical assembly 130 (e.g. via core 120) and
collect light from optical assembly 130 (e.g. via core 120).
Imaging assembly 230 can include a light source 231. Light source
231 can comprise one or more light sources, such as one or more
light sources configured to provide one or more wavelengths of
light to optical assembly 130 via core 120. Light source 231 is
configured to provide light to optical assembly 130 (via core 120)
such that image data can be collected comprising cross-sectional,
longitudinal and/or volumetric information related to the patient
site PS or implanted device being imaged. Light source 231 can be
configured to provide light such that the image data collected
includes characteristics of tissue within the patient site PS being
imaged, such as to quantify, qualify or otherwise provide
information related to a patient disease or disorder present within
the patient site PS being imaged. Light source 231 can be
configured to deliver broadband light and have a center wavelength
in the range from 800 nm to 1700 nm. The light source 231 bandwidth
can be selected to achieve a desired resolution, which can vary
according to the needs of the intended use of system 10. In some
embodiments, bandwidths are about 5% to 15% of the center
wavelength, which allows resolutions of between 20 .mu.m and 5
.mu.m, respectively. Light source 231 can be configured to deliver
light at a power level meeting ANSI Class 1 ("eye safe") limits,
though higher power levels can be employed. In some embodiments,
light source 231 delivers light in the 1.3 .mu.m band at a power
level of approximately 20 mW. Tissue light scattering is reduced as
the center wavelength of delivered light increases, however water
absorption also increases. Light source 231 can deliver light at a
wavelength approximating 1300 nm to balance these two effects.
Light source 231 can be configured to deliver shorter wavelength
light (e.g. approximately 800 nm light) to traverse patient sites
to be imaged including large amounts of fluid. Alternatively or
additionally, light source 231 can be configured to deliver longer
wavelengths of light (e.g. approximately 1700 nm light), such as to
reduce a high level of scattering within a patient site to be
imaged.
[0183] Imaging assembly 230 (or another component of console 200)
can comprise a fiber optic rotary joint (FORJ) configured to
transmit light from light source 231 to core 120, and to receive
light from core 120. In some embodiments, core 120 comprises a
fiber with a first numerical aperture (NA), and imaging assembly
230 comprises an imaging assembly optical core with a second NA
different than the first NA. For example, the first NA (the NA of
of core 120) can comprise an NA of approximately 0.16 and the
second NA (the NA of the imaging assembly optical core) can
comprise an NA of approximately 0.11. In some embodiments, system
10 comprises an adaptor 310 configured to optically connect probe
100 to imaging assembly 230 (e.g. a single use or limited use
disposable adaptor used in less procedures than imaging assembly
230). Adaptor 310 can comprise a lens assembly configured to
"optically match" (e.g. to minimize coupling losses) different
numerical apertures (such as the first and second NAs described
hereabove). In some embodiments, adaptor 310 comprises a fiber with
an NA that is the geometric mean of the two different NAs. In some
embodiments, adaptor 310 comprises a fiber with an NA that is the
arithmetic mean of the two different NAs.
[0184] Rotation assembly 210 can be constructed and arranged to
rotate core 120 (and subsequently one or more components of optical
assembly 130), at a rotational velocity of approximately 250 rps,
or at a rotational velocity between 40 rps and 1000 rps. Rotation
assembly 210 can be configured to rotate core 120 at a rate between
20 rps and 2500 rps. In some embodiments, rotation assembly 210 can
be configured to rotate core 120 at a rate up to 25,000 rps. In
some embodiments, the rotation rate provided by rotation assembly
210 is variable, such as when the rotation rate is varied based on
a signal provided by a sensor of system 10, such as when one or
more of functional elements 53, 83, 93, 113, 123, 133, 203 and/or
303 comprise a sensor, and algorithm 240 is used to analyze one or
more signals from the one or more sensors. In some embodiments, the
sensor signal represents the amount of light collected from tissue
or other target. In some embodiments, system 10 is configured to
vary the rotation rate provided by rotation assembly 210 when the
sensor signal correlates to a parameter selected from the group
consisting of: tortuosity of vessel in which probe 100 is placed;
narrowing of vessel in which probe 100 is placed; presence of clot
proximate optical assembly 130; presence of an implanted device
proximate optical assembly 130; and combinations thereof. In some
embodiments, the rotation rate provided by rotation assembly 210 is
varied by an operator of system 10 (e.g. a clinician).
Alternatively or additionally, system 10 can vary the rotation rate
provided by rotation assembly 210 automatically or at least
semi-automatically ("automatically" herein), such as an automatic
variation of a rotation rate as determined by one or more signals
from one or more sensors as described hereabove. In some
embodiments, rotation by rotation assembly 210 is increased
(manually or automatically) when optical assembly 130 is collecting
image data from a target area.
[0185] In some embodiments, rotation assembly 210 is constructed
and arranged to rotate core 120 at one rate (e.g. at least 150 rps
or approximately 250 rps) during image data collection (i.e. an
"imaging mode"), and at a different rate (e.g. a slower rate, such
as a rate between 30 rps and 150 rps), during a "preview mode".
During preview mode, a "positioning operation" can be performed in
which optical assembly 130 is linearly positioned and/or a flush
procedure can be initiated. The positioning operation can be
configured to visualize bright reflections (e.g. via one or more
implants such as an implanted stent, flow director and/or coils).
Alternatively or additionally, the preview mode can be configured
to allow an operator (e.g. a clinician) to confirm that optical
assembly 130 has exited the distal end 59 of a surrounding delivery
catheter 50. The preview mode can be configured to reduce time and
acceleration forces associated with rotating core 120 at a velocity
to accommodate image data collection (e.g. a rotational velocity of
at least 150 rps or approximately 250 rps).
[0186] Retraction assembly 220 can be constructed and arranged to
retract optical assembly 130 (e.g. by core 120 and/or retracting
shaft 100) at a retraction rate of approximately 40 mm/sec, such as
a retraction rate between 3 mm/sec and 500 mm/sec (e.g. between 5
mm/sec and 60 mm/sec, or approximately 50 mm/sec). Retraction
assembly 220 can be constructed and arranged to perform a pullback
of between 20 mm and 150 mm (e.g. a pullback of approximately 50 mm
or 75 mm), such as a pullback that is performed in a time period
between 0.1 seconds and 15.0 seconds, such as a period between 0.1
and 10 seconds, or a period of approximately 4 seconds. In some
embodiments, pullback distance and/or pullback rate are operator
selectable and/or variable (e.g. manually or automatically). In
some embodiments, the pullback distance and/or pullback rate
provided by retraction assembly 220 is variable, such as when the
pullback distance and/or pullback rate is varied based on a signal
provided by a sensor of system 10, such as when one or more of
functional elements 53, 83, 93, 113, 133, 203 and/or 303 comprise a
sensor, and algorithm 240 is used to analyze one or more signals
from the one or more sensors. In some embodiments, the sensor
signal represents the amount of light collected from tissue or
other target. In some embodiments, system 10 is configured to vary
the pullback distance and/or pullback rate provided by retraction
assembly 220 when the sensor signal correlates to a parameter
selected from the group consisting of: tortuosity of vessel in
which probe 100 is placed; narrowing of vessel in which probe 100
is placed; presence of clot proximate optical assembly 130;
presence of an implanted device proximate optical assembly 130; and
combinations thereof. In some embodiments, the pullback distance
and/or pullback rate provided by retraction assembly 220 is varied
by an operator of system 10 (e.g. a clinician). Alternatively or
additionally, system 10 can vary the pullback distance and/or
pullback rate provided by retraction assembly 210 automatically or
at least semi-automatically ("automatically" herein), such as an
automatic variation of a pullback distance and/or pullback rate as
determined by one or more signals from one or more sensors as
described hereabove. In some embodiments, pullback distance and/or
pullback rate by retraction assembly 220 is varied (increased or
decreased, manually or automatically) when optical assembly 130 is
collecting image data from a target area.
[0187] In some embodiments, retraction assembly 220 and probe 100
are configured such that during image data collection, retraction
assembly 220 retracts core 120 without causing translation to shaft
110 (e.g. core 120 retracts within lumen 112 of shaft 110).
[0188] In some embodiments, retraction assembly 220 and probe 100
can be configured such that during image data collection,
retraction assembly 220 retracts core 120 and shaft 110 in unison.
In these embodiments, shaft 110 can comprise a relatively short
viewing window, viewing portion 117 surrounding optical assembly
130, since optical assembly 130 does not translate within shaft
110. For example, in these embodiments, viewing portion 117 can
comprise a length less than or equal to 20 mm, less than or equal
to 15 mm, less than or equal to 6 mm, or less than or equal to 4
mm, such as when viewing portion 117 comprises a length of
approximately 3 mm. In some embodiments, viewing portion 117
comprises a length between 5 mm and 50 mm, such as a length of
approximately 10 mm or approximately 12 mm. In these embodiments in
which optical assembly 130 does not translate within shaft 110,
shaft 110 diameter (ID and/or OD) can be reduced at locations
proximal to viewing portion 117, such as when the OD of shaft 110
(at least the portion of shaft 110 surrounding and proximate
optical assembly), comprises a diameter of less than or equal to
0.025'', 0.016'' or 0.014''. Alternatively or additionally, in
these embodiments in which optical assembly 130 does not translate
within shaft 110, portions of the shaft proximal to optical
assembly 130 (e.g. proximal to viewing portion 117) can include a
non-transparent construction, such as a braided construction or a
construction using materials such as metal tubing (e.g. nitinol or
stainless steel hypotube), such as to improve pushability of probe
100.
[0189] Retraction assembly 220 can be configured to minimize
formation of bubbles within any fluid (e.g. fluid 190) within shaft
110, such as by retracting shaft 110 and core 120 in unison, or by
retracting core 120 at a precision rate to avoid bubble formation.
When shaft 110 is retracted, proximal portion 111a can be
configured to be positioned in a service loop. Retraction assembly
220 can comprise a translatable slide, and rotation assembly 210
can be positioned on the translatable slide.
[0190] Retraction assembly 220 can comprise a telescoping
retraction assembly. Retraction assembly 220 can comprise a motor,
such as a single use or otherwise sometimes disposable motor, such
as a disposable motor that is part of a telescoping retraction
assembly.
[0191] In some embodiments, rotation assembly 210 can be
independently positioned in reference to retraction assembly 220.
In some embodiments, retraction assembly 220 is configured to be
positioned closer to the patient than the rotation assembly 210 is
positioned (e.g. when retraction assembly 220 is positioned within
20 cm of a vascular introducer or other patient introduction device
through which probe 100 is inserted). In some embodiments,
retraction assembly 220 is configured to removably attach to a
patient introduction device, such as to connect to a Touhy
connector of a vascular introducer through which probe 100 is
inserted, such as a delivery catheter 50 described herein.
[0192] In some embodiments, retraction assembly 220 receives
"motive force" from console 200, such as via drive shaft 211 that
may be operably attached to rotation assembly 210 as shown in FIG.
1.
[0193] Console 200 can comprise a display 250, such as a display
configured to provide one or more images (e.g. video) based on the
collected image data. Imaging assembly 230 can be configured to
provide an image on display 250 with an updated frame rate of up to
approximately 250 frames per second (e.g. similar to the rotational
velocity of core 120). Display 250 can provide a 2-D and/or 3-D
representation of 2-D and/or 3-D data.
[0194] Console 200 can comprise one or more functional elements,
such as functional element 203 shown in FIG. 1. Functional element
203 can comprise one or more functional elements such as one or
more sensors, transducers and/or other functional elements as
described in detail herebelow.
[0195] Console 200 can comprise an algorithm, such as algorithm 240
shown, which can be configured to adjust (e.g. automatically and/or
semi-automatically adjust) one or more operational parameters of
system 10, such as an operational parameter of console 200, probe
100 and/or a delivery catheter 50. Alternatively or additionally,
algorithm 240 can be configured to adjust an operational parameter
of a separate device, such as injector 300 or implant delivery
device 80 described herebelow. In some embodiments, algorithm 240
is configured to adjust an operational parameter based on one or
more sensor signals, such as a sensor signal provided by a
sensor-based functional element of the present inventive concepts
as described herein (e.g. a signal provided by one or more of
functional elements 53, 83, 93, 113, 123, 203 and/or 303).
Algorithm 240 can be configured to adjust an operational parameter
selected from the group consisting of: a rotational parameter such
as rotational velocity of core 120 and/or optical assembly 130; a
retraction parameter of shaft 110 and/or optical assembly 130 such
as retraction velocity, distance, start position, end position
and/or retraction initiation timing (e.g. when retraction is
initiated); a position parameter such as position of optical
assembly 130; a line spacing parameter such as lines per frame; an
image display parameter such as a scaling of display size to vessel
diameter; a probe 100 configuration parameter; an injectate 305
parameter such as a saline to contrast ratio configured to
determine an appropriate index of refraction; a light source 231
parameter such as power delivered and/or frequency of light
delivered; and combinations of one or more of these. In some
embodiments, algorithm 240 is configured to adjust a retraction
parameter such as a parameter triggering the initiation of the
pullback, such as a pullback that is initiated based on a parameter
selected from the group consisting of: lumen clearing; injector 300
signal; change in image data collected (e.g. a change in an image,
based on the image data collected, that correlates to proper
evacuation of blood from around optical assembly 130); and
combinations of one or more of these. In some embodiments,
algorithm 240 is configured to adjust a probe 100 configuration
parameter, such as when algorithm 240 identifies (e.g.
automatically identifies via an RF or other embedded ID) the
attached probe 100 and adjusts a parameter such as arm path length
and/or other parameter as listed above.
[0196] Injector 300 can comprise a power injector, syringe pump,
peristaltic pump or other fluid delivery device configured to
inject a contrast agent, such as radiopaque contrast, and/or other
fluids. In some embodiments, injector 300 is configured to deliver
contrast and/or other fluid (e.g. contrast, saline and/or Dextran).
In some embodiments, injector 300 delivers fluid in a flushing
procedure as described herebelow. In some embodiments, injector 300
delivers contrast or other fluid through a delivery catheter 50
with an ID of between 5 Fr and 9 Fr, a delivery catheter 50 with an
ID of between 0.53'' to 0.70'', or a delivery catheter 50 with an
ID between 0.0165'' and 0.027''. In some embodiments, contrast or
other fluid is delivered through a delivery catheter as small as 4
Fr (e.g. for distal injections). In some embodiments, injector 300
delivers contrast and/or other fluid through the lumen of one or
more delivery catheters 50, while one or more smaller delivery
catheters 50 also reside within the lumen 52. In some embodiments,
injector 300 is configured to deliver two dissimilar fluids
simultaneously and/or sequentially, such as a first fluid delivered
from a first reservoir and comprising a first concentration of
contrast, and a second fluid from a second reservoir and comprising
less or no contrast. Injector 300 can comprise one or more
functional elements, such as functional element 303 shown in FIG.
1. Functional element 303 can comprise one or more functional
elements such as one or more sensors, transducers and/or other
functional elements as described in detail herebelow.
[0197] Implant 85 can comprise an implant (e.g. a temporary or
chronic implant) for treating one or more of a vascular occlusion
or an aneurysm. In some embodiments, implant 85 comprises one or
more implants selected from the group consisting of: a flow
diverter; a Pipeline.TM. flow diverter; a Surpass.TM. flow
diverter; an embolization coil; a stent; a Wingspan.TM. stent; a
covered stent; an aneurysm treatment implant; and combinations of
one or more of these. Delivery device 80 can comprise a catheter or
other tool used to deliver implant 85, such as when implant 85
comprises a self-expanding or balloon expandable portion. Implant
delivery device 80 can comprise a functional element, such as
functional element 83 shown in FIG. 1. Functional element 83 can
comprise one or more functional elements such as one or more
sensors, transducers and/or other functional elements as described
in detail herebelow. In some embodiments, system 10 comprises a
probe 100, one or more implants 85 and/or one or more implant
delivery devices 80, such as is described in applicant's co-pending
application U.S. Provisional Application Ser. No. 62/212,173,
titled "Imaging System includes Imaging Probe and Delivery
Devices", filed Aug. 31, 2015; the content of which is incorporated
herein by reference in its entirety for all purposes. In some
embodiments, probe 100 is configured to collect data related to
implant 85 and/or implant delivery device 80 (e.g. implant 85
and/or implant delivery device 80 anatomical location, orientation
and/or other configuration data), after implant 85 and/or implant
delivery device 80 has been inserted into the patient.
[0198] Treatment device 91 can comprise an occlusion treatment or
other treatment device selected from the group consisting of: a
balloon catheter constructed and arranged to dilate a stenosis or
other narrowing of a blood vessel; a drug eluting balloon; an
aspiration catheter; a sonolysis device; an atherectomy device; a
thrombus removal device such as a stent retriever device; a
Trevo.TM. stentriever; a Solitaire.TM. stentriever; a Revive.TM.
stentriever; an Eric.TM. stentriever; a Lazarus.TM. stentriever; a
stent delivery catheter; a microbraid implant; an embolization
system; a WEB.TM. embolization system; a Luna.TM. embolization
system; a Medina.TM. embolization system; and combinations of one
or more of these. In some embodiments, treatment device 91
comprises a therapeutic device selected from the group consisting
of: stent retriever; embolization coil; embolization coil delivery
catheter; stent; covered stent; stent delivery device; aneurysm
treatment implant; aneurysm treatment implant delivery device; flow
diverter; balloon catheter; and combinations thereof. In some
embodiments, probe 100 is configured to collect data related to
treatment device 91 (e.g. treatment device 91 location, orientation
and/or other configuration data), after treatment device 91 has
been inserted into the patient. Treatment device 91 can comprise a
functional element, such as functional element 93 shown in FIG.
1.
[0199] 2.sup.nd Imaging device 92 can comprise an imaging device
such as one or more imaging devices selected from the group
consisting of: an X-ray; a fluoroscope such as a single plane or
biplane fluoroscope; a CT Scanner; an MM; a PET Scanner; an
ultrasound imager; and combinations of one or more of these.
[0200] Functional elements 53, 83, 93, 113, 123, 133, 203, and/or
303 can each comprise one or more sensors, transducers and/or other
functional elements, as described in detail herebelow.
[0201] In some embodiments, a functional element 113 is positioned
proximate optical assembly 130 (e.g. functional element 113b
positioned distal to optical assembly 130 as shown in FIG. 1A, at
the same axial location as optical assembly 130 and/or proximal to
optical assembly 130). In some embodiments, imaging probe 100
comprises functional element 113a shown in FIG. 1. Functional
element 113a is shown positioned on a proximal portion of shaft
110, however it can be positioned at another probe 100 location
such as on, in and/or within connector 102. Functional elements
113a and/or 113b (singly or collectively functional element 113)
can each comprise one or more functional elements such as one or
more sensors, transducers and/or other functional elements as
described in detail herebelow.
[0202] In some embodiments, functional element 53, 83, 93, 113,
123, 133, 203 and/or 303 comprise a sensor, such as a sensor
configured to provide a signal related to a parameter of a system
10 component and/or a sensor configured to provide a signal related
to a patient parameter. Functional element 53, 83, 93, 113, 123,
133, 203 and/or 303 can comprise one or more sensors selected from
the group consisting of: a physiologic sensor; a pressure sensor; a
strain gauge; a position sensor; a GPS sensor; an accelerometer; a
temperature sensor; a magnetic sensor; a chemical sensor; a
biochemical sensor; a protein sensor; a flow sensor such as an
ultrasonic flow sensor; a gas detecting sensor such as an
ultrasonic bubble detector; a sound sensor such as an ultrasound
sensor; and combinations of one or more of these. In some
embodiments, functional element 53, 83, 93, 113, 123, 133, 203
and/or 303 can comprise one or more physiologic sensors selected
from the group consisting of: a pressure sensor such as a blood
pressure sensor; a blood gas sensor; a flow sensor such as a blood
flow sensor; a temperature sensor such as a blood or other tissue
temperature sensor; and combinations of one or more of these. In
some embodiments, algorithm 240 is configured to process the signal
received by a sensor, such as a signal provided by a sensor as
described herein. In some embodiments, functional element 53, 83,
93, 113, 123 and/or 133 comprises a position sensor configured to
provide a signal related to a vessel path (e.g. a vessel lumen
path) in three dimensions. In some embodiments, functional element
53, 83, 93, 113, 123 and/or 133 comprises a magnetic sensor
configured to provide a signal for positioning optical assembly 130
relative to one or more implanted devices (e.g. one or more
implants 85 described herein comprising a ferrous or other magnetic
portion). In some embodiments, functional element 53, 83, 93, 113,
123 and/or 133 comprises a flow sensor, such as a flow sensor
configured to provide a signal related to blood flow through a
blood vessel of the patient site PS (e.g. blood flow through a
stenosis or other partially occluded segment of a blood vessel). In
these embodiments, algorithm 240 can be configured to assess blood
flow (e.g. assess the significance of an occlusion), such as to
provide information to a clinician regarding potential treatment of
the occlusion. In some embodiments, optical assembly 130 comprises
functional element 113, such as when optical assembly 130 is
constructed and arranged as a sensor that provides a signal related
to blood flow. In some embodiments, functional element 53, 83, 93,
113, 123 and/or 133 comprises a flow sensor configured to provide a
signal used to co-register vessel anatomic data to flow data, which
can be used to provide pre and post intervention modeling of flow
(e.g. aneurysm flow), assess risk of rupture and/or otherwise
assess adequacy of the intervention. In some embodiments,
functional element 53, 83, 93, 113, 123 and/or 133 comprises an
ultrasound sensor configured to provide a signal (e.g. image or
frequency data) which can be co-registered with near field optical
derived information provided by optical assembly 130. In some
embodiments, functional element 53, 83, 93 and/or 113 are
configured to be deployed by their associated device, such as to
implant the functional element (e.g. a sensor-based functional
element) into the patient. The implantable functional element 53,
83, 93 and/or 113 can comprise microchip and/or MEMS components.
The implantable functional element 53, 83, 93 and/or 113 can
comprise at least a portion that is configured to be visualized
(e.g. by image data collected by probe 100 and/or a separate
imaging device such as second imaging device 92.
[0203] In some embodiments, functional element 53, 83, 93, 113,
123, 133, 203 and/or 303 comprise one or more transducers selected
from the group consisting of: a heating element such as a heating
element configured to deliver sufficient heat to ablate tissue; a
cooling element such as a cooling element configured to deliver
cryogenic energy to ablate tissue; a sound transducer such as an
ultrasound transducer; a vibrational transducer; and combinations
of one or more of these.
[0204] In some embodiments, functional element 53, 83, 93 and/or
113 comprises a pressure release valve configured to prevent
excessive pressure from accumulating in the associated device. In
some embodiments, functional element 53, 83, 93 and/or 113
comprises one or more sideholes, such as one or more sideholes used
to deliver a fluid in a flushing procedure as described herein.
[0205] In some embodiments, functional element 53, 83, 93, 113,
123, 133, 203 and/or 303 comprise a visualizable marker, such as
when functional element 53, 83, 93 and/or 113 comprise a marker
selected from the group consisting of: radiopaque marker;
ultrasonically reflective marker; magnetic marker; ferrous
material; and combinations of one or more of these.
[0206] Probe 100 is configured to collect image data, such as image
data collected during rotation and/or retraction of optical
assembly 130. Optical assembly 130 can be rotated by rotating core
120. Optical assembly 130 can be retracted by retracting shaft 110.
Optical assembly 130 can collect image data while surrounded by a
portion of a shaft of a delivery catheter 50 (e.g. when within a
transparent segment 57 of a delivery catheter) and/or when there is
no catheter 50 segment surrounding optical assembly 130 (e.g. when
optical assembly 130 has been advanced beyond the distal ends 59 of
all delivery catheters 50 into which probe 100 is inserted).
[0207] During collection of image data, a flushing procedure can be
performed, such as by delivering one or more fluids, injectate 305
(e.g. as propelled by injector 300 or other fluid delivery device),
to remove blood or other somewhat opaque material (hereinafter
non-transparent material) proximate optical assembly 130 (e.g. to
remove non-transparent material between optical assembly 130 and a
delivery catheter and/or non-transparent material between optical
assembly 130 and a vessel wall), such as to allow light distributed
from optical assembly 130 to reach and reflectively return from all
tissue and other objects to be imaged. In these flushing
embodiments, injectate 305 can comprise an optically transparent
material, such as saline. Injectate 305 can comprise one or more
visualizable materials, as described herebelow. Injectate 305 can
be delivered by injector 300 as described hereabove.
[0208] Flush rates required for providing clearance around optical
assembly 130 can scale inversely with the viscosity of the flush
medium. This mathematical relationship can be driven by the
downstream draining of the flush medium in the capillary bed. If
the capillary bed drains slowly, it is easier to maintain the
upstream flush at a pressure at or slightly above native blood
pressure, such that fresh blood will not enter the vessel being
imaged (e.g. at a location proximate optical assembly 130).
Conversely, if the capillary bed drains rapidly, the flush rate
will need to increase correspondingly. Since saline (a standard
flush medium) has a viscosity about 1/3 that of blood (e.g. 1 Cp vs
3.3 Cp), roughly three times normal flow rate will be required to
clear a vessel (in the area proximate optical assembly 130), and
such flow rates can pose a risk to vessel integrity. As an
alternative, contrast media (e.g. radiopaque contrast media) can be
used for flushing. Contrast material has a high viscosity (due to
its high iodine concentrations, typically a concentration of
approximately 300 mg/ml). System 10 can comprise a flushing fluid
comprising contrast, such as contrast with a concentration between
50 mg/ml to 500 mg/ml of iodine (e.g. correlating to viscosities
approximately two to five times that of blood). System 10 can
comprise a flushing fluid (e.g. a radiopaque or other visualizable
flushing fluid) with a viscosity between 1.0 Cp and 20 Cp (e.g. at
a temperature of approximately 37.degree. C.).
[0209] Alternative or in addition to its use in a flushing
procedure, injectate 305 can comprise material configured to be
viewed by second imaging device 92, such as when injectate 305
comprise a contrast material configured to be viewed by a second
imaging device 92 comprising a fluoroscope or other X-ray device;
an ultrasonically reflective material configured to be viewed by a
second imaging device 92 comprising an ultrasound imager; and/or a
magnetic material configured to be viewed by a second imaging
device 92 comprising an MRI.
[0210] Injectate 305 can be delivered by one or more delivery
catheters 50 (e.g. in the space between a first delivery catheter
50 and an inserted delivery catheter 50, or in the space between a
delivery catheter 50 and an inserted probe 100). Injectate 305
delivered in a flushing procedure (or other injectate 305 delivery
procedure) can be delivered out the distal end 59 of a delivery
catheter 50 (e.g. a distal end 59 positioned proximal to optical
assembly 130), such as is described in applicant's co-pending U.S.
Provisional Application Ser. No. 62/212,173, titled "Imaging System
includes Imaging Probe and Delivery Devices", filed Aug. 31, 2015,
the content of which is incorporated herein by reference in its
entirety for all purposes. Alternatively or additionally, any
delivery catheter 50 can comprise one or more sideholes passing
through a portion of the associated shaft 51, such as sideholes 58
shown positioned on a distal portion of delivery catheter 50c. In
some embodiments, a delivery catheter 50 comprises a microcatheter
comprising sideholes 58 positioned on a distal portion, such as a
microcatheter with an ID less than 0.027'' (e.g. a microcatheter
with an ID between 0.016'' and 0.027'' or an ID between 0.021'' and
0.027''). In some embodiments, flushing fluid is delivered towards
optical assembly 130 from both sideholes 58 and from the distal end
59 of a delivery catheter 50. Sideholes 58 can be constructed and
arranged to allow a flushing fluid to pass from within shaft 51 and
through the sideholes 58, such as when a separate shaft is inserted
within the delivery catheter 50 (e.g. a shaft 51 of an additional
delivery catheter 50 or the shaft 110 of probe 100). Delivery of
flushing fluid through sideholes 58 and/or the distal end of the
delivery catheter 50 can be performed to clear blood from an area
from a luminal segment surrounding optical assembly 130, such as
during collecting of image data.
[0211] In some embodiments, the delivery of injectate 305 during a
flushing procedure is based on a parameter selected from the group
consisting of: a pre-determined volume of injectate to be
delivered; a pre-determined time during which injectate is
delivered; an amount of time of delivery including a time extending
from a time prior to retraction of shaft 110 that continued until
the collecting of the image data has been completed (e.g.
completion of retraction of shaft 110); and combinations of one or
more of these. In some embodiments, injector 300 delivers fluid in
a flushing procedure with an approximate flow profile selected from
the group consisting of: contrast (e.g. between 20% and 100%
contrast that can be mixed with saline) at 5 ml/second for 6
seconds (e.g. for imaging of a carotid artery including 4 seconds
of collecting image data); contrast (e.g. between 20% and 100%
contrast that can be mixed with saline) at 4 ml/second for 6
seconds (e.g. for imaging of a vertebral artery including 4 seconds
of collecting image data); and combinations of one or more of
these. In some embodiments, a flushing procedure comprises delivery
of injectate 305 (e.g. via one or more delivery catheters 50) for
between 2 seconds to 8 seconds, such as a delivery of injectate for
approximately 4 seconds (e.g. to purge blood or other
non-transparent fluid from a luminal segment of a blood vessel or
other area surrounding optical assembly 130 during collection of
image data from a patient site PS). In similar flushing procedures,
injectate 305 can be delivered at a rate between 3 ml/second and 9
ml/second (e.g. approximately 6 ml/sec via one or more delivery
catheters 50), to purge non-transparent material.
[0212] In these flushing procedures, injectate 305 can comprise a
transparent fluid selected from the group consisting of: saline;
contrast; Dextran; and combinations of one or more of these. In
some embodiments, the volume of injectate 305 delivered and/or the
time of injectate 305 delivery during a flushing procedure is
determined by a parameter selected from the group consisting of:
type of procedure being performed; diameter of vessel in which
optical assembly 130 is positioned; length of pullback; duration of
pullback; and combinations of one or more of these. In some
embodiments, injectate 305 is delivered during a flushing procedure
by a delivery catheter with an ID greater than 0.027'' (e.g. a
first delivery catheter 50 whose distal end 59 is more proximal
than a second delivery catheter 50 inserted into the first delivery
catheter 50). In some embodiments, injectate 305 is delivered via
multiple lumens 52 in associated multiple delivery catheters 50
(e.g. in the space between two or more pairs of delivery catheters
50 arranged to slidingly receive each other in a sequential
fashion).
[0213] In some embodiments, injectate comprises a first fluid
delivered in a first portion of a flushing procedure (e.g. a fluid
comprising saline and/or a fluid comprising no or minimal
contrast), and a second fluid including contrast (e.g. a second
fluid comprising saline and contrast), such as to limit the amount
of contrast delivered to the patient during the flush procedure. In
these embodiments, injector 300 can comprise two reservoirs (as
described hereabove), such as a first reservoir for supplying the
first fluid and a second reservoir for supplying the second fluid.
When comprised of two reservoirs, injector 300 can be configured to
deliver the fluids in each reservoir at different rates, such as to
achieve different pressures and/or to provide flushing through
different catheters with different IDs.
[0214] As described herein, optical assembly 130 can be rotated
(e.g. via rotation of core 120) and retracted (e.g. via retraction
of shaft 110 by retraction assembly 220) during collection of image
data, such as a rotation combined with retraction to create a 3D
image of the patient site PS. In some embodiments, optical assembly
130 is rotated at a rate between 40 rps and 1000 rps, such as a
rate of approximately 250 rps. In some embodiments, optical
assembly 130 is rotated at a first rate during an imaging mode, and
a second rate during a preview mode (imaging mode and preview mode
each described hereabove). In some embodiments, the retraction of
optical assembly 130 spans of distance of between 1 cm and 15 cm,
such as a retraction of approximately 4 cm. In some embodiments,
optical assembly 130 is retracted at a rate of between 1 mm/sec and
60 mm/sec. In some embodiments, the retraction of optical assembly
130 comprises a retraction of approximately 7.5 cm over 4 seconds
and/or a retraction rate of approximately 20 mm/sec. In some
embodiments, retraction of optical assembly 130 comprises a
resolution of between 5 .mu.m and 20 .mu.m axially and/or a
resolution between 20 .mu.m and 100 .mu.m longitudinally. The
longitudinal resolution is governed by two factors: the spot-size
(light beam cross-section) at the tissue surface being imaged and
the spacing between successive rotations of optical assembly 130
during retraction. For a rotation rate of 100 rps and a pullback
rate of 22 mm/sec, a pitch of 200 .mu.m between rotations results.
In these configurations, a spot size between 20 .mu.m and 40 .mu.m
would result in collecting image data which under-samples the
objects being imaged. System 10 can be configured to more closely
match spot size with pitch, such as by correlating spot size with
rotation rate and/or pullback rate.
[0215] In some embodiments, imaging system 10 is constructed,
arranged and used to create an image as described in applicant's
co-pending U.S. Provisional Application Ser. No. 62/212,173, titled
"Imaging System includes Imaging Probe and Delivery Devices", filed
Aug. 31, 2015; the content of each of which is incorporated herein
by reference in its entirety for all purposes.
[0216] In some embodiments, system 10 is configured to assist in
the selection, placement and/or use of a treatment device 91.
Treatment device 91 can comprise a stent retriever configured to
remove thrombus or other occlusive matter from a patient, such as
when imaging probe 100 images the anatomy and/or the treatment
device 91 to produce anatomical information (e.g. used to select
the size or other geometry of the stent retriever), visualize the
stent retriever at the occlusive site (e.g. to position treatment
device 91), and or visualize occlusive matter (e.g. thrombus)
engaged with and/or not removed by the treatment device 91. In some
embodiments, system 10 is configured to quantify a thrombus volume,
such as a thrombus to be removed by a treatment device 91. Thrombus
visualized by system 10 can comprise thrombus selected from the
group consisting of: residual thrombus in acute stroke; thrombus
remaining after a thrombus removal procedure; thrombus present
after flow diverter implantation; and combinations thereof.
[0217] In some embodiments, system 10 is configured to provide
anatomical information to be used to select a site of implantation
and/or to select a particular implantable device to be implanted in
the patient, such as implant 85 of system 10 described hereabove.
System 10 can be configured to image at least one perforator artery
of the patient, such as to image one, two or more perforator
arteries of at least 50 .mu.m in diameter. Implant 85 can be
implanted in the patient via implant delivery device 80, such as
when implant 85 comprises a stent and/or a flow diverter. System 10
can be configured to perform a function selected from the group
consisting of: detect and/or quantify implant 85 apposition (e.g. a
stent or flow diverter malapposition); provide quantitative and/or
qualitative information regarding the size and/or placement of an
implant 85 to be implanted in a patient, such as information
related to perforator location; perforator geometry, neck size
and/or flow diverter mesh density; and combinations of one or more
of these. System 10 can be configured to provide information
related to an implant 85 parameter selected from the group
consisting of: porosity; length; diameter; and combinations
thereof. System 10 can be configured to provide implant 85 porosity
information comprising the porosity of one or more portions of
implant 85, such as a portion to be positioned proximate a
sidebranch of a vessel in which implant 85 is implanted. System 10
can be configured to provide porosity information based on a wire
diameter of implant 85. System 10 can be configured to provide
information related to the implantation (e.g. implantation site or
device information) of a second implant 85 to be implanted in the
patient. In these embodiments in which two implanted devices 85 are
used, the first and second implanted devices can comprise similar
or dissimilar devices (e.g. a stent and a flow diverter, two stents
or two flow diverters). System 10 can be configured to collect
image data during deployment of one or more implants 85. System 10
can be configured to collect image data used to modify an implanted
device (e.g. during and/or after implantation), such as to modify
the porosity of implant 85 (e.g. via a treatment device 91
comprising a balloon catheter used to adjust the porosity of a
partially or fully implanted implant 85).
[0218] Imaging conventionally inaccessible areas of the body (e.g.
coronary arteries, neurovascular arteries, the endocrine system,
pulmonary airways, etc.) using specialized catheters has been in
use for several decades. Even so, products for these applications
are still being widely developed as technological advances allow
higher resolution, new modalities (e.g. spatially-resolved
spectroscopy), and lower cost probes to be realized. Limitations
and other issues with the current catheters are described
herebelow. Such imaging catheters commonly utilize high-speed
rotation of distally-located optics to create a cross sectional
view of a body lumen since reduced diameter imaging catheters
generally precludes the use of conventional optics or so-called
coherent fiber bundles. Rather than creating a multi-pixel
conventional `snapshot`, the image with rotating optics is built up
one or two pixels at a time by scanning a single imaging spot,
similar to the raster scan employed by older CRT's. This rotation
may be coupled with a longitudinal motion (`pull-back`) to create a
spiral scan of the artery or lumen, which can be rendered as a 3-D
image. The majority of currently available imaging catheters have a
distally located imaging element, connected optically or
electrically to a proximal end. The imaging element is attached to
a mechanical transmission that provides rotation and pullback to
occur. Recently, advances in micro-motor technology can supplant
the mechanical transmission with distally located actuation, but
pullback is still required. However, these motors are expensive and
relatively large (available designs do not allow probes below 1 mm
OD to be constructed).
[0219] There are a number of commercially available "torque shafts"
which are miniature wire-wound tubes intended to transmit torque
over a long and flexible shaft. Such devices are now commonly used
in intravascular ultrasound (IVUS) procedures as well as OCT
procedures. Imaging probes combined with torque shafts perform
rotational scanning in coronary arteries for example. Generally
however, these devices are approximately 0.8 to 1.3 mm in OD, (2.4
Fr to 4 Fr) and are thus 2 to 4 times larger than the devices
required by neurological applications. Presently, such torque wires
are not scalable to the sizes required to permit the construction
of scanning imaging catheters less than 0.7 mm in OD.
[0220] Since optical imaging in arteries necessitates the clearing
of obfuscating blood, usually with a flush solution, the imaging
catheter diameter becomes critically important in smaller or
obstructed vessels (e.g. due to use of smaller guides). Since it is
often diseased or obstructed vessels that require imaging for
diagnosis and treatment, imaging probe 100 can be designed for a
small diameter (e.g. an OD less than or equal to 0.025'', 0.016''
or 0.014'').
[0221] As has been previously disclosed (Petersen, et al U.S. Pat.
No. 6,891,984 [the '984 patent]; Crowley U.S. Pat. No. 6,165,127
[the '127 patent], the content of each of which is incorporated
herein by reference in its entirety for all purposes), using a
viscous fluid located at the distal region of the imaging catheter
is provided to prevent twisting.
[0222] Achieving uniform rotational scanning at the distal tip of a
single fiber imaging catheter, while maintaining an overall device
size less than 500 .mu.m in OD is a significant challenge. Because
it is currently impractical to add a motor to the distal tip that
is sized less than 1 mm in OD (see Tsung-Han Tsai, Benjamin
Potsaid, Yuankai K. Tao, Vijaysekhar Jayaraman, James Jiang, Peter
J. S. Heim, Martin F. Kraus, Chao Zhou, Joachim Hornegger, Hiroshi
Mashimo, Alex E. Cable, and James G. Fujimoto; "Ultrahigh speed
endoscopic optical coherence tomography using micro-motor imaging
catheter and VCSEL technology", Biomed Opt Express. 2013 Jul. 1;
4(7): 1119-1132), with the attendant wires and size issues, a way
must be found to apply torque to the proximal end and transmit the
torque to the distal tip (which may be as much as three meters away
in some clinical applications) while maintaining uniform rotational
speed. Uniform speed is paramount to image fidelity as non-uniform
rotation can lead to image smearing and severe distortions (See
FIG. 3). If the extremely low inherent rotational stiffness of a
glass fiber is considered, the issues of uniformly spinning the
distal tip by driving the proximal end can be appreciated. Uniform
rotation is critically important in endoscopic techniques in order
to obtain accurate circumferential images. The term `NURD`
(non-uniform rotational distortion) has been coined in the industry
to describe these deleterious effects.
[0223] An example of distortion caused by non-uniform rotational
distortion (NURD) is shown in FIG. 3. The solid curve is a
simulated perfectly round artery, 4 mm in diameter. The curve with
square data points is the image of the same arterial wall with
NURD. In this case, the catheter rotation is slowed by 50% over a
small portion of the cycle, and sped up by 50% in another portion,
such that the average distal rotational speed matches the proximal
rotational speed (as it must, otherwise rapidly accumulating twist
would cause the core 120 to break). It can be seen that this NURD
can lead to significant measurement errors. The imaging probe 100
and other components of system 10 are configured to reduce these
types of distortions.
[0224] The '127 patent discloses the use of a viscous fluid located
inside the bore of an ultrasound catheter. The purpose of the fluid
is to provide loading of a torque wire such that the wire enters
the regime of high torsional stiffness at moderate spin rates. As
described in the '127 patent, this fluid is housed within a
separate bore formed inside the main catheter, increasing the
overall size of the device. The fluid does not contact the imaging
tip, nor does the ultrasound energy propagate through this fluid.
This approach also requires the use of a torque wire, limiting the
achievable reduction in size needed. In the imaging probe of the
present inventive concepts, one or more viscous fluids (e.g. one or
more fluids 190) can be provided to deliberately cause twisting
(i.e. winding) of core 120. The twisting can comprise dynamic
twisting that changes with total (i.e. end-to-end) frictional load
(torque) of probe 100, to result in a relatively constant
rotational rate. Probe 100 can be configured such that the amount
of twisting changes during a pullback of one or more portions of
probe 100 (e.g. a pullback of core 120 and/or a pullback of core
120 and shaft 110).
[0225] The '984 patent utilizes a viscous fluid with a high index
of refraction to simultaneously reduce refractive effects at the
curved sheath boundary as well as provide viscous loading to allow
an optical fiber to be the torque transmitter. This configuration
allows a certain reduction in size. However, the '984 patent fails
to describe or disclose a mechanism for confining the fluid at the
distal tip within the geometry constraints; unavoidable migration
of this fluid during transport and storage will cause unavoidable
loss of performance. Similarly, the '984 patent fails to address
issues that could arise during pullback of the internal fiber which
will cause voids to form in the viscous fluid, these voids causing
relatively large optical effects (so-called `bubble-artifacts`,
see, for example, "Expert review document on methodology,
terminology, and clinical applications of optical coherence
tomography: physical principles, methodology of image acquisition,
and clinical application for assessment of coronary arteries and
atherosclerosis", Francisco Prati, et al, European heart Journal,
Nov. 4, 2009). In some embodiments, probe 100 is configured to
rotate core 120 in a single direction (i.e. unidirectional) during
use. In some embodiments, probe 100 comprises a torque shaft within
shaft 110 and frictionally engaged with core 120, such as torque
shaft 110b described herebelow. Torque shaft 110b can extend from
the proximal end of probe 100 to a location proximal to optical
assembly 130, such as a torque shaft with a distal end that is
located at least 5 cm from optical assembly 130, or a distal end
that is located proximal to the most proximal location of shaft 110
that is positioned within the patient.
[0226] A liquid, gel or other fluid-filled (e.g. and sealed)
imaging probe 100 has the advantage that it does not require
purging (e.g. to remove air bubbles). The fluid 190a or 190b can be
configured as a lubricant, reducing friction between core 120 and
shaft 110. In embodiments in which core 120 is pulled back relative
to shaft 110 to obtain an image, a void is created at the end of
core 120 that can be filled with liquid, gel or other fluid (e.g.
fluid 190).
[0227] It is difficult for fluid to "fill in" this region as it
must be provided from the proximal end of shaft 110 and travel the
length of the core 120. Bubbles are likely to form here as a low
pressure can be generated. In embodiments of the present inventive
concepts, rather than retracting the core 120 within shaft 110, the
entire imaging probe 100 is pulled back during image data
collection (i.e. core 120 and shaft 110 are retracted in unison
without relative axial motion between the two). Since the shaft 110
moves along with the core 120, the presence of a low-pressure
region at the end of the imaging core is eliminated or at least
mitigated.
[0228] As shown in FIG. 4, such "mutual" motion of shaft 110 and
core 120 allows shaft 110 to have a larger diameter around optical
assembly 130, as relative motion between optical assembly 130 and
shaft 110 is avoided. A larger diameter optical assembly 130 (e.g.
a larger diameter lens of optical assembly 130) provides collection
of more light, which can correlate to a brighter image. This
configuration can also provide a lens of optical assembly 130 that
has a focal length that is positioned farther away from the OD
(i.e. outer surface) of shaft 110 surrounding optical assembly 130,
improving distal image quality. Alternatively or additionally, and
also as shown in FIG. 4, optical assembly 130 can comprise an OD
that is larger than an ID of at least a portion of shaft 110
proximal to optical assembly 130. In these embodiments, optical
assembly 130 and shaft 110 can be retracted simultaneously during
collection of image data from a target area.
[0229] In some embodiments, the shaft 110 wall is relatively
thicker over a majority of its length as compared to a thinner wall
of shaft 110 at a distal portion of shaft 110 (e.g. thinner at a
shaft 110 portion proximate optical assembly 130). Such a
configuration allows for improved longitudinal and torsional
control for positioning of imaging probe 100. In some embodiments,
shaft 110 can comprise a stiffened portion positioned about optical
assembly 130, such as a stiffened segment of shaft 110 comprising:
a different (stiffer) wall material; a braided shaft portion; and
or a stiffening element (e.g. a wire embedded in the wall of shaft
110). The stiffened distal portion of shaft 110 can correlate to a
thinner wall, which in turn correlates to optical assembly 130
comprising larger optical components (e.g. one or more larger
diameter lenses), for example without having to increase the OD of
shaft 110 surrounding optical assembly 130. In some embodiments,
shaft 110 has varying mechanical properties along its length (e.g.
a stiffened proximal segment for "push-ability"), and a gradually
decreasing stiffness distally (e.g. to improve deliverability and
safety as advanced into tortuous anatomy).
[0230] Also as shown in FIG. 4, optical assembly 130 can comprise a
lens 131 and a reflecting element 132 (e.g. to "turn" the light).
Reflecting element 132 is configured such that optical assembly 130
is asymmetrical. When optical assembly 130 is spun at high speed,
the presence of viscous liquids or other viscous fluids in the
optical path surrounding optical assembly 130 could, in some cases,
cause cavitation in the region behind reflector 132. As shown in
FIG. 5, in some embodiments, probe 100 includes a first fluid,
fluid 190a that surrounds core 120, and a second, different fluid,
fluid 190b, that surround optical assembly 130, such that fluid
190a can be configured to provide a first function (e.g. prevent or
at least reduce undesired rotational variances of core 120), while
fluid 190b provides a second function (e.g. prevent or at least
reduce cavitation about optical assembly 130). In some embodiments,
the viscosity of fluid 190b can be selected to be relatively low
viscosity, such as to minimize cavitation, while the viscosity of
fluid 190a can be selected to be relatively high (e.g. at least
more viscous than fluid 190b) to optimize uniformity in the
rotational speed.
[0231] In neurological placement, imaging probe 100 is usually
placed into a femoral vessel of the patient. There is significant
tortuosity in the vasculature proximal to a neurological imaging
area, starting with the carotid artery take off from the aorta. In
some embodiments, the use of a high viscosity fluid 190a in the mid
and/or proximal section of imaging probe 100 allows the fluid 190a
to provide the additional function of lubricating the spinning core
120 in the shaft 110 (e.g. lubrication of benefit due to the high
tortuosity in which imaging probe 100 is placed). The reduced
friction that results reduces the stress on the core 120, and
allows smoother motions over any discontinuities in shaft 110 or
core 120. Fluid 190 can be configured to provide sufficient
lubrication or other advantageous parameter to eliminate or at
least reduce ("reduce" herein) adverse effects that would otherwise
occur as probe 100 is positioned in tortuous anatomy (e.g. when
distal portion 119a is positioned proximate and distal to the
carotid artery). In these embodiments, fluid 190 can comprise a
high viscosity fluid.
[0232] Additionally, the presence of a high viscosity fluid 190a
helps maintain the lower viscosity fluid 190b in the distal end of
shaft 110 prior to use, as the higher viscosity fluid 190a in shaft
110 operates as a barrier, and reduces the likelihood of fluid 190b
migration from the imaging region about optical assembly 130 prior
to use (e.g. during sterilization and shipping of imaging probe
100). In some embodiments, a sealing element, such as sealing
element 116, is positioned between two or more different fluids
190. Alternatively, no separating element may be present, such as
when one or more of the fluids 190 comprise a gel configured not to
mix with a neighboring fluid 190.
[0233] In some embodiments, imaging probe 100 includes an inertial
assembly comprising an impeller, propeller or other inertia-based
element configured to reduce undesired variances in rotational
speed of optical assembly 130, such as is shown in FIG. 6. Imaging
probe 100 comprises impeller 182 that is attached to the core 120.
Drag on impeller 182 "winds up" core 120 and decreases unintended
or otherwise undesired variances in rotational velocity of the
fiber. Impeller 182 operates to spin the fluid 190 between shaft
110 and optical assembly 130. The impeller 182 blades form drag,
which due to its symmetry around its rotational axis, remains
uniform through the rotation. In some embodiments, the radial
extending ends of impeller 182 intentionally contact an inner wall
of shaft 110, to alternatively or increasingly provide drag.
Impeller 182 can comprise one or more projections from core 120,
such as projections that frictionally engage shaft 110 and/or
otherwise cause shear force that applies a load to core 120 during
rotation. Impeller 182 can comprise one or more projections from
shaft 110, such as projections that frictionally engage core 120
and/or otherwise cause shear force that applies a load to core 120
during rotation.
[0234] Impeller 182 can be configured to cause wind-up loading of
core 120. Impeller 182 can be configured to frictionally engage
fluid 190 and/or shaft 110 during rotation of core 120. Impeller
182 can comprise a component selected from the group consisting of:
turbine; vane-type micro-structure; flywheel; and combinations of
one or more of these.
[0235] Liquid, gel or other fluid positioned inside shaft 110 can
have a tendency to form bubbles. If these bubbles are in the
optical path they will reduce the light transmission. In some
embodiments, fluid 190a and/or fluid 190b (singly or collectively
fluid 190) can be pressurized (e.g. to a pressure of 100 psi or
above) to prevent or at least reduce the size of any bubbles in
shaft 110, such as is described herein in reference to FIG. 7.
[0236] Small tire inflators are commonly used for filling bicycle
tires. They are available in sizes smaller than 1 inch, which is
suitable for this application. These and similarly configured
inflators can provide pressures up to and beyond 100 psi, which
when applied to fluid 190 can significantly reduce the bubble size.
Assuming a bubble size at atmospheric pressure is to be 0.1
microliters, the bubble size at 100 psi can be calculated as:
V.sub.p=V.sub.aP.sub.a/P.sub.p
[0237] where:
[0238] V.sub.p=Bubble volume under pressure
[0239] V.sub.a=Bubble volume at atmospheric pressure (e.g. 0.1
.mu.L)
[0240] P.sub.a=Atmospheric pressure (14.7 PSI)
[0241] P.sub.p=Pressurizing device pressure (e.g. 100 psi)
[0242] Under pressurization, the bubble volume decreases from 0.1
.mu.L to 0.0147 .mu.L. The corresponding bubble diameter is reduced
from 0.022'' to 0.011'', which will mitigate or eliminate
deleterious effects on the optical beam.
[0243] FIG. 7 is a sectional view of an imaging probe including a
pressurization system, consistent with the present inventive
concepts. Imaging probe 100 comprises shaft 110 with proximal end
111, lumen 112, core 120 and optical connector 102, each of which
can be of similar construction and arrangement as those described
hereabove in reference to FIG. 1. Imaging probe 100 can include
pressurization assembly 183 (e.g. a pressurized gas canister) which
can be fluidly connected to lumen 112 via valve 184 (e.g. a one way
check valve). In some embodiments, each imaging probe 100 is
provided with a pressurization assembly 183. Alternatively, a
single pressurization assembly 183 can be reused (e.g. used on
multiple imaging probes 100 in multiple clinical procedures). In
some embodiments, pressurization assembly 183 can be pre-attached
to shaft 110, or separated and attachable. In some embodiments,
pressurization assembly 183 can be operably attached and/or
activated just prior to the time of clinical use of imaging probe
100, such as to pressurize fluid within lumen 112 or other imaging
probe 100 internal location, such as to reduce the size of one or
more gas bubbles in a fluid, such as fluid 190 described
herein.
[0244] In some embodiments, at a location near to proximal end 111
of shaft 110, sealing element 151 (e.g. a compressible O-ring) is
positioned between core 120 and shaft 110. Shaft 110 and sealing
element 151 can be constructed and arranged to maintain a relative
seal as lumen 112 is pressurized (e.g. as described above), while
allowing core 120 to rotate within shaft 110 and sealing element
151. Sealing element 151 can provide a seal during rotation of core
120 within shaft 110. Retraction of shaft 110 and core 120
simultaneously during imaging, as described herein, simplifies the
design of sealing element 151. In some alternative embodiments,
core 120 is retracted within shaft 110, and sealing element 151 is
configured to maintain a seal during that retraction.
[0245] In some embodiments, at least a portion of shaft 110 is
configured to radially expand as fluid 190 is pressurized, such as
is shown in FIGS. 15A-C. Pressurization assembly 183 is attached to
connector 102 such that fluid 190 can be introduced and/or
pressurized into and/or within shaft 110. In FIG. 15A, proximal
portion 111a of shaft 110 is expanded (e.g. lumen 112 is expanded
in the region of proximal portion 111a). In FIG. 15B, proximal
portion 111a and mid portion 115 of shaft 110 are expanded. In FIG.
15C, proximal portion 111a, mid portion 115 and distal portion 119a
are expanded. In these embodiments, system 10 can be configured to
rotate core 120 after shaft 110 has been fully expanded as shown in
FIG. 15C. Expansion of shaft 110 can create and/or increase space
between core 120 and the inner wall of shaft 110. In some
embodiments, shaft 110 remains at least partially expanded (e.g.
shaft 110 has been plastically deformed) when the pressure of fluid
190 is decreased (e.g. to atmospheric pressure). Shaft 110 can be
configured to expand to a first diameter (ID and/or OD) when fluid
190 is pressurized to a first pressure, and to expand to a second,
larger diameter, when fluid 190 is pressurized to a second, higher
pressure. In some embodiments, shaft 110 is configured to become
more rigid as the pressure of fluid 190 increases.
[0246] There can be two attachments from probe 100 (e.g. a
disposable catheter) to the non-disposable components of system 10.
One is attached to shaft 110 (a non-rotating shaft) and the other
to core 120. Attachment of imaging probe 100 to console 200 can
comprise two functional attachments. One attachment comprises
attachment of shaft 110 to a retraction assembly, such as
retraction assembly 220 described herein, such that shaft 110 (and
optic assembly 130) can be retracted during collection of image
data. Another attachment comprises attaching core 120 to a
rotational assembly, such as rotation assembly 210, such that core
120 can be rotated during collection of image data. Both
attachments can be retracted together during collection of image
data. The attachment of core 120 makes the optical connection
between core 120 and an imaging assembly (e.g. imaging assembly 230
described herein) and can provide the motive power to rotate core
120 (e.g. an attachment to rotation assembly 210).
[0247] The imaging system and associated imaging probes of the
present inventive concepts provide enhanced compatibility with
traditional therapeutic catheters, such as those used in
neurological procedures as described herein.
[0248] Stent retrieval devices (also referred to as "stent
retrievers") are used for endovascular recanalization. While the
rate of successful revascularization is high, multiple passes of
the stent retrieval device are often required to fully remove the
clot, adding to procedure times and increasing likelihood of
complications. The addition of imaging to a stent retrieval
procedure has the potential to reduce both procedure time and
complications. In FIGS. 8-11, system 10 comprises imaging probe 100
and a therapeutic device, treatment device 91. While treatment
device 91 is shown as a stent retriever, other therapeutic devices
would be applicable, such as a treatment device 91 selected from
the group consisting of: stent retriever; embolization coil;
embolization coil delivery catheter; stent; covered stent; stent
delivery device; aneurysm treatment implant; aneurysm treatment
implant delivery device; flow diverter; balloon catheter; and
combinations thereof. Imaging probe 100 and treatment device 91
have been placed into a vessel, such as a blood vessel of the neck
or head. Imaging probe 100 and treatment device 91 can be
insertable into a single catheter, such as delivery catheter 50d
shown.
[0249] Positioning of optical assembly 130 and resulting images
produced assure correct placement of the treatment device 91 (e.g.
positioning of the stent retriever distal to the thrombus) and also
assures that therapy is completed successfully (e.g. sufficient
thrombus has been removed), which can both reduce procedure times
and improve clinical results.
[0250] In some embodiments, system 10 comprises delivery catheter
50a (not shown, but such as a 6-8 Fr guide catheter) that can be
placed into a target vessel (e.g. artery), such as by using
transfemoral access. In some embodiments, delivery catheter 50a
comprises a standard balloon guide catheter, such as to prevent
distal thrombus migration and to enhance aspiration during
thrombectomy. System 10 can further comprise delivery catheter 50b
(not shown but such as a flexible 5-6 Fr catheter) that is used as
an intermediate catheter, advanced through delivery catheter 50a to
gain distal access close to the occluded segment of the vessel.
System 10 can comprise a third delivery catheter 50c, shown, such
as a 0.021'' to 0.027'' microcatheter used to cross the thrombus or
otherwise provide access to a target site to be treated and/or
imaged. Angiographic runs can be performed through the delivery
catheter 50c to angiographically assess the proper position of the
delivery catheter 50c tip (e.g. position of tip distal to the
thrombus and to estimate the length of the clot). The treatment
device 91 (e.g. the stent retriever shown) is subsequently released
by pulling back delivery catheter 50c while holding the treatment
device 91 in place. In some embodiments, the treatment device 91
should cover the entire length of an occlusion in order to achieve
flow restoration (e.g. when the stent portion opens).
[0251] In FIG. 8, a distal portion of delivery catheter 50c has
been positioned in a blood vessel (e.g. within a vessel location
including thrombus). A stent portion of treatment device 91 remains
undeployed, captured within the distal portion of delivery catheter
50c. In FIG. 9, delivery catheter 50c is retracted, such that the
stent portion of treatment device 91 deploys (e.g. to engage
thrombus, thrombus not shown). In FIG. 10, imaging probe 100 is
advanced through the deployed stent portion of treatment device 91.
Image data can be collected during the advancement. In FIG. 11,
imaging probe 100 is being retracted (optical assembly 130 passes
through the stent portion of treatment device 91) as image data is
collected, such as to perform a procedural assessment as described
herein.
[0252] In some embodiments, system 10 is constructed and arranged
such that proximally applied torque (e.g. to core 120) and distally
applied rotational speed control (e.g. to core 120 and/or optical
assembly 130) is provided. This configuration has several benefits,
including but not limited to: small size; low-cost; and an
independence from the tortuous path proximal to the distal tip of
imaging probe 100.
[0253] In some embodiments, system 10 is configured to provide
precise rotational control (e.g. avoid undesired rotational speed
variances of core 120 and/or optical assembly 130) via inertial
damping, such as inertial damping which increases with rotational
speed. This control can be accomplished with: a viscous fluid in
contact with core 120 and/or optical assembly 130 (e.g. fluid 190a
and/or 190b described herein); a fluid in contact with a mechanical
load such a vane-type micro-structure; a mechanical load acting as
a flywheel; and combinations thereof.
[0254] In some embodiments, imaging probe 100 comprises a guidewire
independent design, comprising a shaft 110 with an OD of 0.016'' or
less (e.g. approximately 0.014''), and configured such that its
shaft 110, core 120 and optical assembly 130 are retracted in
unison using external pullback (e.g. retraction assembly 220
described herein).
[0255] In some embodiments, imaging probe 100 is configured to be
advanced through vessels to a target site with or without the use
of a microcatheter.
[0256] In some embodiments, imaging probe 100 is configured such
that core 120 and optical assembly 130 are configured to be
retracted within shaft 110 during image data collection, such as an
internal pullback using purge media (e.g. fluid 190 or other purge
media introduced between the core 120 and the shaft 110). In some
embodiments, the introduced material is configured to provide a
function selected from the group consisting of: index matching;
lubrication; purging of bubbles; and combinations thereof.
[0257] In some embodiments, imaging probe 100 comprises an Rx tip.
In these embodiments, imaging probe 100 can be configured such that
core 120 and optical assembly 130 are configured to be retracted
within shaft 110 during image data collection.
[0258] In some embodiments, imaging probe 100 comprises a highly
deliverable, very small cross-section probe. In some embodiments,
shaft 110 comprises one or more optically transparent materials
providing an optically transparent window, viewing portion 117,
positioned within distal portion 119a of shaft 110. Viewing portion
117 can comprise a length between 1 mm and 100 mm, such as a length
of approximately 3 mm. In some embodiments, viewing portion 117 can
comprise a length less than 50 mm, such as less than 20 mm or less
than 15 mm (e.g. a relatively short window in embodiments in which
both shaft 110 and optical assembly 130 are retracted
simultaneously during the collection of image data). Viewing
portion 117 can comprise a material selected from the group
consisting of: nylon; nylon 12; nylon 66; and combinations of one
or more of these. In some embodiments, at least a portion of shaft
110 comprises a reinforced portion, such as a reinforced portion
comprising a stiffening element (e.g. stiffening element 118 shown
in FIG. 1). In some embodiments, stiffening element 118 terminates
proximal to optical assembly 130 (e.g. proximal to viewing portion
117 of shaft 110). Alternatively, stiffening element 118 can extend
beyond optical assembly 130, such as is shown in FIG. 2, and the
pullback geometry can be coordinated such that the light path to
and from optical assembly 130 avoids the stiffening element 118.
Stiffening element 118 can be included to resist twisting of distal
portion 119a, such as during rotation of the core 120. For example,
stiffening element 118 can comprise an element selected from the
group consisting of: a coil; a metal coil; a metal coil wound over
a plastic such as PTFE; a tube; a metal tube; a metal and/or
plastic braid positioned within the wall of shaft 110; and
combinations thereof. In some embodiments, shaft 110 comprises a
stiffening element 118 comprising a coil wound in a direction such
that rotation of the core 120 tends to cause the coil to tighten
(e.g. to further resist twisting of shaft 110). In some
embodiments, one or more portions of stiffening element 118 come
into contact with a fluid maintained within shaft 110 (e.g. fluid
190 described herein), such that twisting of shaft 110 is reduced
by torque forces applied by the fluid to stiffening element
118.
[0259] In some embodiments, system 10 includes integration of
imaging probe 100 with one or more therapeutic devices (e.g. one or
more treatment devices 91). For example, a treatment device 91 can
comprise a stent retriever, and system 10 can provide real time
simultaneous visualization of one or more of: the patient's anatomy
(e.g. blood vessel wall and other tissue of the patient); the
treatment device 91 (e.g. one or more struts of treatment device
91); and/or thrombus or other occlusive matter. The simultaneous
visualization can be correlated to reduced procedure time and
improved efficacy.
[0260] In some embodiments, system 10 is configured to apply
proximal pressure to imaging probe 100, such as to keep the distal
portion bubble-free or at least to mitigate bubble generation
within one or more fluids 190 of imaging probe 100.
[0261] As described herein, imaging probe 100 can comprise a core
120 including a thin fiber that can be optically coupled on its
distal end to optical assembly 130 comprising a lens assembly. In
some embodiments, a fluid interacting element (e.g. a coil or
length of wound wire, though not necessarily a torque wire), can be
positioned just proximal to optical assembly 130 (e.g. embedded in
the wall of or within shaft 110). In some embodiments, the shaft
110 can be filled with a low viscosity fluid 190, such as to
interact with the fluid interacting element and create drag. The
coil or other fluid interacting element, in contrast to a
conventional torque wire, is not wound to create a high-fidelity
transmission of torque but to increase viscous drag. The fluid 190
can be low viscosity (e.g. with a viscosity at or below 1000 Cp) to
allow for easier filling and will reduce bubble artifacts created
in high viscosity solutions. The fluid interacting element can
comprise an impeller, such as impeller 182 described herein. The
fluid interacting element comprises a non-circular cross section
portion of a portion of shaft 110, such as a cross section with a
geometry selected from the group consisting of: polygon shaped
cross section of a lumen of shaft 110; projections into a lumen of
shaft 110; recesses in inner diameter (i.e. the inner wall) of
shaft 110; and combinations of one or more of these.
[0262] In some embodiments, imaging probe 100 comprises a formed
element to create viscous drag, such as impeller 182 described
herein. This element can have a variety of shapes designed to
maximize the interaction with an internal fluid 190.
[0263] In some embodiments, imaging probe 100 is constructed and
arranged such that viscous drag is created by mechanical friction
between a part rigidly coupled to core 120 and in close contact
with the wall of shaft 110. The friction may be created by the
shear force of a narrow annulus between the mechanical element and
the shaft 110 wall, such as when the shaft 110 is filled with fluid
190.
[0264] In some embodiments, imaging probe 100 comprises at least
one fluid 190 that is contained by at least one sealing element
(e.g. sealing element 116 and/or sealing element 151 described
herein). Sealing element 116 and/or 151 can be constructed and
arranged to allow core 120 to rotate in the sealed region while
preventing the (viscous) fluid 190 to penetrate through the seal.
In some embodiments, two sealing elements 116a and 116b are
included, such as one positioned just proximal to the optical
assembly 130 and one positioned further distal, such as is shown in
FIG. 17. In these embodiments, the separation distance between the
two sealing elements 116 and/or the viscosity of the captured fluid
190 can be chosen to create sufficient torsional loading as core
120 is rotated. In some embodiments, the two sealing elements 116a
and 116b are positioned apart at a distance between 1 mm and 20 mm.
In some embodiments, the fluid 190 comprises a viscosity between 10
Cp and 100 Cp.
[0265] In some embodiments, system 10 comprises an imaging probe
100 and a console 200. Imaging probe 100 comprises: a proximal end
111 and a distal end 119, and at least one lumen 112 extending
between the proximal end 111 and the distal end 119. Core 120 is
positioned within lumen 112, the proximal end of core 120 in
optical and mechanical communication with console 200, and the
distal end of core 120 in optical communication with an optical
assembly configured to collect image data within a body lumen.
[0266] In some embodiments, imaging probe 100 comprises optical
assembly 130 located at the distal end of core 120, optical
assembly 130 in mechanical and optical communication with core 120,
the optical assembly 130 directing light to the target (e.g.
thrombus, vessel wall, tissue and/or implant) being imaged and
collecting return light from the imaged target. Imaging probe 100
can further comprise an inertial system (e.g. impeller 182) located
proximate the distal end of the core 120, wherein the inertial
system reduces undesired rotational speed variances that occur
during a rotation of the core 120. The inertial system can comprise
a (predetermined) length of wound hollow core cable, the distal end
of the cable being affixed to core 120 just proximal to optical
assembly 130, the proximal end unattached (e.g. not attached to
core 120). The inertial system can comprise a mechanical resistance
element located in the distal region of core 120, and can be in
contact with a fluid 190 confined within a lumen 112 of shaft 110,
the mechanical resistance arising during rotation within the fluid
190.
[0267] In some embodiments, imaging probe 100 comprises a sealing
element, such as sealing element 151 described herein, located
within lumen 112 of shaft 110. Sealing element 151 can be
configured to allow rotation of core 120 while forming
substantially liquid-tight seals around core 120 and the inner wall
of shaft 110. In some embodiments, sealing element 151 is further
configured as a mechanical resistance element. In some embodiments,
sealing element 151 is formed from a hydrogel. In some embodiments,
the sealing element 151 is formed by an adhesive (e.g. a UV-cured
adhesive), bonding to the inner wall of shaft 110, but not the
surface of core 120. In some embodiments, the surface of core 120
is configured to avoid bonding to an adhesive (e.g. a UV adhesive).
In some embodiments, the sealing element 151 is formed from a
compliant material such as a silicone rubber.
[0268] In some embodiments, an imaging system comprises an imaging
probe 100 and an imaging console, console 200. The imaging probe
100 comprises: a proximal end 111, a distal end 119, and at least
one lumen 112 extending between the proximal end 111 and distal end
119. The imaging probe further comprises: a core 120 contained
within a lumen 112 of the shaft 110, the proximal end of core 120
in optical and mechanical communication with console 200, the
distal end optically connected to an optical assembly 130
configured to collect image data within a body lumen. Optical
assembly 130 is positioned at the distal end of the core 120, and
is configured to direct light to the target (e.g. thrombus, vessel
well, tissue and/or implant) being imaged and collecting return
light from the imaged target.
[0269] In some embodiments, imaging probe 100 comprises a core 120
and one, two or more inertial elements, such as impeller 182
described herein, attached to optical assembly 130 and/or core 120
(e.g. attached to a distal portion of core 120). Impeller 182 can
be configured such that when the core 120 is retracted (e.g. in the
presence of liquid, gel or gaseous medium, such as fluid 190), the
impeller 182 imparts a rotational force to core 120, such as to
reduce undesired rotational speed variances. Impeller 182 can
comprise a turbine-like construction.
[0270] In some embodiments, system 10 comprises an imaging probe
100 and an imaging console, console 200. Imaging probe 100
comprises a proximal end 111, a distal end 119, and at least one
lumen 112 extending between proximal end 111 and distal end 119.
Imaging probe 100 can further comprise a rotatable optical core,
core 120 contained within a lumen 112 of shaft 110, the proximal
end of core 120 in optical and mechanical communication with
console 200, and the distal end configured to collect image data
from a body lumen.
[0271] As described herein, imaging probe 100 comprises optical
assembly 130 which is positioned at the distal end of core 120.
Optical assembly 130 is in mechanical and optical communication
with core 120, and is configured to direct light to tissue target
being imaged and collect return light from the imaged target.
Imaging probe 100 can further comprise a reinforcing or other
stiffening element (e.g. stiffening element 118 described herein)
embedded into shaft 110 that creates an improved stiffness but
effectively optically transparent window for rotational and
pullback scanning. Stiffening element 118 can comprise an embedded
wire and/or a stiffening member (e.g. a plastic stiffening member)
in shaft 110. Stiffening element 118 can comprise a spiral
geometry. As described hereabove, the spiral geometry of stiffening
element 118 and a pullback spiral rotational pattern of optical
assembly 130 can be matched but offset by approximately one-half of
the spiral of stiffening element 118, such that an imaging beam of
optical assembly 130 passes between the stiffening 118 spirals
during pullback of optical assembly 130.
[0272] Referring now to FIG. 12, a side sectional view of the
distal portion of probe 100 is illustrated, having been inserted
into a vessel, such that optical assembly 130 is positioned within
treatment device 91 (e.g. a stent deployment device, stent
retriever or other treatment device), consistent with the present
inventive concepts. Probe 100 comprises shaft 110, core 120,
optical assembly 130, lens 131 and reflector 132, and those and
other components of probe 100 can be of similar construction and
arrangement to those described hereabove. In some embodiments,
distal end 119 comprises a geometry and/or a stiffness to enhance
advancement of distal end 119 through blood vessels and/or one or
more devices positioned within a blood vessel. For example, distal
end 119 can comprise the bullet-shaped profile shown in FIG. 12.
Alternatively or additionally, treatment device 91 can comprise a
proximal portion (e.g. proximal end 91a shown), which can be
configured to enhance delivery of distal end 119 through proximal
end 91a. In some embodiments, probe 100 comprises a spring tip,
such as spring tip 104 described hereabove.
[0273] Probe 100 and other components of system 10 can be
configured to allow a clinician or other operator to "view" (e.g.
in real time) the collection of thrombus or other occlusive matter
into treatment device 91, such as to determine when to remove
treatment device 91 and/or how to manipulate treatment device 91
(e.g. a manipulation to remove treatment device 91 and/or
reposition treatment device 91 to enhance the treatment). The
ability to view the treatment can avoid unnecessary wait time and
other delays, as well as improve efficacy of the procedure (e.g.
enhance removal of thrombus).
[0274] Referring now to FIG. 13, a side sectional view of the
distal portion of probe 100 is illustrated, consistent with the
present inventive concepts. Probe 100 comprises shaft 110, lumen
112, core 120, optical assembly 130, lens 131 and reflector 132,
and those and other components of probe 100 can be of similar
construction and arrangement to those described hereabove. In some
embodiments, distal portion 119a of shaft 110 comprises a
reinforcing element, stiffening element 118a as shown in FIG. 13.
Inclusion of stiffening element 118a can allow the wall of shaft
110 surrounding optical assembly 130 to be thin (e.g. thinner than
the wall in a more proximal portion of shaft 110). Stiffening
element 118a can comprise an optically transparent material as
described herein. Stiffening element 118a can be configured to
provide column and/or torsional strength to shaft 110. In some
embodiments, probe 100 comprises a lumen narrowing structure, such
as tube 114 shown positioned within lumen 112 of shaft 110. Tube
114 can be adhesively or at least frictionally engaged with the
inner wall of shaft 110 or the outer surface of core 120. In some
embodiments, tube 114 is simply a projection from the inner wall of
shaft 110 (e.g. part of shaft 110). Tube 114 can be configured to
provide a function selected from the group consisting of: increase
torsional strength of shaft 110; increase column strength of shaft
110; provide a capillary action between fluid surrounding core 120
and/or optical assembly 130; and combinations thereof. In some
embodiments, probe 100 comprises fluid 190a and/or fluid 190b
shown, such as is described hereabove. Fluid 190a and fluid 190b
can comprise similar or dissimilar fluids. In some embodiments,
fluid 190a and/or fluid 190b comprise a low viscosity fluid as
described hereabove. In some embodiments, fluid 190a and/or fluid
190b comprise a shear-thinning fluid as described hereabove.
[0275] Referring now to FIG. 14, a schematic of an imaging probe is
illustrated, shown in a partially assembled state and consistent
with the present inventive concepts. Probe 100 can comprise a first
portion, comprising a connector 102a, outer shaft 110a and spring
tip 104, constructed and arranged as shown in FIG. 14. Probe 100
can further comprise a second portion, connector 102b, torque shaft
110b, core 120 and optical assembly 130. Outer shaft 110a, spring
tip 104, core 120 and optical assembly 130 and other components of
probe 100 can be of similar construction and arrangement to those
described hereabove. Connector 102b can be of similar construction
and arrangement to connector 102 described hereabove, such as to
optically connect probe 100 to console 200. Connector 102a can be
configured to surround and mechanically engage connector 102b, such
that connectors 102a and/or 102b mechanically connect to console
200.
[0276] Torque shaft 110b frictionally engages core 120 (e.g. via an
adhesive), at least at a distal portion of torque shaft 110b.
Torque shaft 110b can be attached to connector 102b via an adhesive
or other mechanical engagement (e.g. via a metal tube, not shown,
but such as a tube that is pressed into connector 102b). In some
embodiments, a strain relief is provided at the end of torque shaft
110b, tube 121 shown. Tube 121 can be configured to reduce kinking
and/or to increase the fixation between torque shaft 110b and core
120. Tube 121 and torque shaft 110b can have similar IDs and/or
ODs.
[0277] During assembly, torque shaft 110b, optical assembly 130 and
core 120 are positioned within shaft 110a. Connector 102a can be
engaged with connector 102b to maintain relative positions of the
two components.
[0278] Torque shaft 110b can comprise one or more plastic or metal
materials, such as when torque shaft 110b comprises a braided
torque shaft (e.g. a braid comprising at least stainless steel).
Torque shaft 110b can comprise a length such that the distal end of
torque shaft 110b terminates a minimum distance away from optical
assembly 130, such as a length of approximately 49 cm. In some
embodiments, torque shaft 110b comprises a length such that none or
a small portion of torque shaft 110b enters the patient. In these
embodiments, retraction assembly 220 can be positioned and engage
shaft 110 at a location distal to the distal end of retraction
assembly 220.
[0279] Referring now to FIGS. 15A-C, a series of side sectional
views of an imaging probe in a series of expansion steps of its
shaft via an internal fluid, consistent with the present inventive
concepts. Probe 100 comprises connector 102, shaft 110, core 120
and optical assembly 130, and those and other components of probe
100 can be of similar construction and arrangement to those
described hereabove. Shaft 110 comprises proximal portion 111a, mid
portion 115 and distal portion 119a. Probe 100 further comprises
pressurization assembly 183, which may include valve 184, each of
which can be of similar construction and arrangement to the similar
components described hereabove in reference to FIG. 7. Probe 100
can be configured such that as fluid is introduced into lumen 112,
and/or the pressure of fluid within lumen 112 is increased, shaft
110 expands. For example, a first introduction of fluid 190 into
lumen 112 and/or a first increase of pressure of fluid 190 in lumen
112 (e.g. via pressurization assembly 183) can be performed such
that the proximal portion 111a of shaft 110 expands as shown in
FIG. 15A. Subsequently, a second introduction of fluid 190 into
lumen 112 and/or a second increase of pressure of fluid 190 in
lumen 112 can be performed such that the mid portion 115 of shaft
110 expands as shown in FIG. 15B. Subsequently, a third
introduction of fluid 190 into lumen 112 and/or a third increase of
pressure of fluid 190 in lumen 112 can be performed such that the
distal portion 119a of shaft 110 expands as shown in FIG. 15C. In
some embodiments, shaft 110 is expanded to create a space between
the inner wall of shaft 110 and core 120 and/or to create a space
between the inner wall of shaft 110 and optical assembly 130.
[0280] Referring now to FIG. 16, a side sectional view of the
distal portion of an imaging probe comprising a distal marker
positioned in reference to an optical assembly is illustrated,
consistent with the present inventive concepts. Probe 100 comprises
shaft 110, core 120, optical assembly 130, lens 131 and reflector
132, and those and other components of probe 100 can be of similar
construction and arrangement to those described hereabove. Shaft
110 comprises proximal portion 111a (not shown), distal portion
119a and distal end 119. Probe 100 can comprise a functional
element 133a, which can be positioned on or relative to optical
assembly 130 (e.g. positioned on or at a desired and/or known
distance from optical assembly 130). Functional element 133a is
shown positioned distal to optical assembly 130, and at a fixed
distance as determined by a connecting element, tube 134 (e.g. heat
shrink tubing or other plastic tube). In some embodiments,
functional element 133a comprises a sensor, transducer or other
functional element as described herein. In some embodiments,
functional element 133a comprises a visualizable element, such as a
radiopaque element, ultrasonically visible element and/or
magnetically visible element. In some embodiments, functional
element 133a comprises a visualizable element used to identify the
location of optical assembly 130 on an image produced by an imaging
device (e.g. a fluoroscope, ultrasonic imager or MRI) and the fixed
location of functional element 133a relative to optical assembly
130 avoids registration issues, such as would be encountered if
functional element 133a was positioned on shaft 110 or other
component of probe 100 whose dimensions or other relative position
to optical assembly 130 may change over time (e.g. due to expansion
or contraction due to temperature shifts). In some embodiments,
functional element 133a is attached to optical assembly 130 via a
connecting element, such as tube 134 described hereabove, and tube
134 or other connecting element (e.g. connecting element 137
described herein) is configured to avoid dimensional changes (e.g.
is minimally affected by changes in temperature). In some
embodiments, probe 100 comprises fixation element 136 (e.g. an
adhesive such as a UV cured adhesive) positioned just distal to
functional element 133a as shown in FIG. 16, and configured to
maintain the position of functional element 133a.
[0281] Probe 100 can comprise one or more elements that cause
frictional engagement between shaft 110 and core 120 and/or simply
reduce the space between shaft 110 and core 120, such as one or
more of elements 122a, 122b and 122c shown in FIG. 16, such as to
reduce undesired variations in rotational rate as described herein.
In some embodiments, probe 100 comprises a compression element,
band 122a, positioned about and/or within shaft 110 and causing a
portion of the inner wall of shaft 110 to frictionally engage core
120. Alternatively or additionally, shaft 110 can comprise one or
more projections 122b (e.g. annular projections) that extend to
frictionally engage core 120. Alternatively or additionally, core
120 can comprise one or more projections 122c, each extending to
frictionally engage shaft 110. One or more of each of elements
122a, 122b and/or 122c can be included, and each can be configured
to create a shear force that applies a load to core 120 during
rotation of core 120. In some embodiments, a fluid 190 is
positioned between shaft 110 and core 120, such as a shear-thinning
fluid as described herein. In these embodiments, one or more of
elements 122a, 122b and/or 122c can comprise a space reducing
element configured to increase the shear-thinning of the fluid 190
as core 120 is rotated (i.e. by interacting with the fluid 190 to
increase the amount of thinning than that which would have occurred
without the presence of the one or more space reducing elements
122).
[0282] Referring now to FIG. 17, a side sectional view of the
distal portion of an imaging probe comprising two sealing elements
is illustrated, consistent with the present inventive concepts.
Probe 100 comprises shaft 110, core 120, optical assembly 130, lens
131, reflector 132 and viewing portion 117, and those and other
components of probe 100 can be of similar construction and
arrangement to those described hereabove. Shaft 110 comprises lumen
112, proximal portion 111a (not shown), distal portion 119a and
distal end 119. Probe 100 can further comprise spring tip 104.
Probe 100 can comprise functional element 113, as shown, or other
functional elements as described herein. Probe 100 of FIG. 17
comprises two sealing elements, sealing element 116a (e.g. an
O-ring surrounding core 120) and sealing element 116b (e.g. an
elastomeric disk). In some embodiments, a fluid 190b is positioned
within shaft 110 between sealing elements 116a and 116b, such as is
described hereabove. Alternatively or additionally, a second fluid
190a is positioned within shaft 110 proximal to sealing element
116a. In some embodiment, a third fluid 190c (not shown), is
positioned within shaft 110 distal to sealing element 116b. Fluids
190a-c can comprise similar or dissimilar fluids, also as described
hereabove.
[0283] Referring now to FIG. 18, a side sectional view of the
distal portion of an imaging probe comprising a reflecting element
offset from a lens and multiple visualizable markers is
illustrated, consistent with the present inventive concepts. Probe
100 comprises shaft 110, core 120, optical assembly 130, lens 131
and reflector 132, and those and other components of probe 100 can
be of similar construction and arrangement to those described
hereabove. Shaft 110 comprises lumen 112, proximal portion 111a
(not shown), distal portion 119a and distal end 119.
[0284] In some embodiments, reflector 132 can be positioned distal
to lens 131, and connected via connecting element 137, as shown in
FIG. 18 and described hereabove.
[0285] In some embodiments, probe 100 comprises multiple
visualizable markers, such as the four functional elements 123a
shown in FIG. 18, which can be configured to provide a "ruler
function" when visualized by a separate imaging device such as a
fluoroscope, ultrasonic imager or MRI (e.g. when functional
elements 123a comprise a radiopaque marker; an ultrasonically
reflective marker or a magnetic marker, respectively). Functional
elements 123a can comprise one or more visualizable bands (e.g. one
or more compressible bands and/or wire coils) frictionally engaged
with core 120. Alternatively or additionally, one or more
functional elements 123a can be positioned on, within the wall of
and/or on the inner surface of shaft 110. Functional elements 123a
can be positioned equidistantly apart and/or at a known separation
distance. In some embodiments, one or more functional elements 123a
can be further configured as a sealing element (e.g. to provide a
seal to a contained fluid such as one or more fluids 190 described
herein) and/or as a rotational dampener configured to reduce
undesired rotational velocity changes of core 120 and/or optical
assembly 130.
[0286] While the preferred embodiments of the devices and methods
have been described in reference to the environment in which they
were developed, they are merely illustrative of the principles of
the present inventive concepts. Modification or combinations of the
above-described assemblies, other embodiments, configurations, and
methods for carrying out the inventive concepts, and variations of
aspects of the inventive concepts that are obvious to those of
skill in the art are intended to be within the scope of the claims.
In addition, where this application has listed the steps of a
method or procedure in a specific order, it may be possible, or
even expedient in certain circumstances, to change the order in
which some steps are performed, and it is intended that the
particular steps of the method or procedure claim set forth
herebelow not be construed as being order-specific unless such
order specificity is expressly stated in the claim.
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