U.S. patent application number 13/041520 was filed with the patent office on 2011-09-01 for fiber optic imaging catheter.
This patent application is currently assigned to Boston Scientific Scimed, Inc.. Invention is credited to Michael P. Boutillette, David I. Freed, David Micky Graves, M. Kevin Richardson, Paul M. Scopton.
Application Number | 20110213206 13/041520 |
Document ID | / |
Family ID | 35695590 |
Filed Date | 2011-09-01 |
United States Patent
Application |
20110213206 |
Kind Code |
A1 |
Boutillette; Michael P. ; et
al. |
September 1, 2011 |
FIBER OPTIC IMAGING CATHETER
Abstract
A steerable imaging catheter is provided, including an elongated
catheter tube, at least one steering cable extending along the
catheter tube to control the movement of the distal end thereof,
and a fiber optic cable extending along the catheter tube. The
fiber optic cable transmits illumination light from its proximal
end to its distal end and transmits an image from its distal end to
its proximal end. In one embodiment, two or more steering cables
are used, and the catheter tube is configured to have greater
flexibility near its distal end than its proximal end so as to
concentrate the movement (flexing) of the catheter tube at its
distal end. The use of two or more steering cables, together with
the catheter tube having varying flexibility, permit better control
of the distal end of the catheter tube while reducing undue
twisting of the remainder of the catheter tube.
Inventors: |
Boutillette; Michael P.;
(Waltham, MA) ; Graves; David Micky; (Hudson,
MA) ; Richardson; M. Kevin; (Hopkinton, MA) ;
Freed; David I.; (Westborough, MA) ; Scopton; Paul
M.; (Winchester, MA) |
Assignee: |
Boston Scientific Scimed,
Inc.
|
Family ID: |
35695590 |
Appl. No.: |
13/041520 |
Filed: |
March 7, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10914411 |
Aug 9, 2004 |
7922654 |
|
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13041520 |
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Current U.S.
Class: |
600/146 |
Current CPC
Class: |
A61B 2090/306 20160201;
A61B 1/05 20130101; A61B 1/00103 20130101; A61B 1/00135 20130101;
A61B 1/00071 20130101; A61B 1/015 20130101; A61B 2090/061 20160201;
A61B 1/0607 20130101; A61B 1/0051 20130101; A61B 1/00096 20130101;
A61B 1/00165 20130101; A61B 1/018 20130101; A61B 1/0052 20130101;
A61B 1/04 20130101; A61B 2090/3937 20160201; A61B 2090/3614
20160201; A61B 1/0057 20130101; A61B 1/07 20130101 |
Class at
Publication: |
600/146 |
International
Class: |
A61B 1/005 20060101
A61B001/005 |
Claims
1-22. (canceled)
23. A catheter, comprising: an elongated catheter tube having a
proximal end and a distal end; at least one elongate element
extending along the catheter tube substantially from the proximal
end to the distal end of the catheter tube to control movement of
the distal end of the catheter tube; an optical element having a
proximal end and a distal end, the optical element extending along
the catheter tube substantially from the proximal end to the distal
end of the catheter tube, the optical element being configured to
transmit light to a tissue positioned near the distal end of the
optical element and to receive light reflected from the tissue; and
a processor connected to a proximal end of the optical element and
configured to determine a state of the tissue based on a wavelength
of the transmitted light and a wavelength of the received
light.
24. The catheter of claim 23, wherein the state of the tissue is
one of healthy or unhealthy.
25. The catheter of claim 24, wherein unhealthy tissue includes at
least one of cancerous tissue and necrotic tissue.
26. The catheter of claim 23, wherein the processor is configured
to determine a difference between the wavelength of the transmitted
light and the wavelength of the received light.
27. The catheter of claim 26, wherein the processor is configured
to determine the state of the tissue based on a previous difference
determined corresponding to a known healthy tissue.
28. The catheter of claim 23, wherein the optical element is also
configured to transmit illumination from the proximal end of the
optical element to the distal end of the optical element while
transmitting an image from the distal end of the optical element to
the proximal end of the optical element.
29. A method of diagnosing a tissue, comprising: advancing a
catheter to a position in a body of a patient, the catheter having
an elongated catheter tube, and the elongated catheter tube having
at least one elongate element extending along the elongated
catheter tube to control movement of a distal end of the elongated
catheter tube, the elongated catheter tube further having an
optical element extending along the elongated catheter tube,
transmitting light from the optical element to a tissue within the
body of the patient; receiving reflected light from the tissue via
the optical element; and determining, using a processor connected
to a proximal end of the optical element, a state of the tissue
based on a wavelength of the transmitted light and a wavelength of
the received light.
30. The method of claim 29, wherein the state of the tissue
determined is one of healthy or unhealthy.
31. The method of claim 30, wherein unhealthy tissue includes at
least one of cancerous tissue and necrotic tissue.
32. The method of claim 29, wherein the determining step includes
determining a difference between the wavelength of the transmitted
light and the wavelength of the received light.
33. The method of claim 29, further comprising transmitting light
to a known healthy tissue, receiving reflected light from the known
healthy tissue, and determining a state of the known healthy tissue
prior to transmitting light to the tissue.
34. The method of claim 33, wherein determining the state of the
tissue is based on the determination of the state of the known
health tissue.
35. The method of claim 29, further comprising transmitting
illumination from the proximal end of the optical element to the
distal end of the optical element while transmitting an image from
the distal end of the optical element to the proximal end of the
optical element.
36. The method of claim 30, further comprising a step of removing
the unhealthy tissue.
37. The method of claim 36, wherein the step of removing the
unhealthy tissue includes delivering radio frequency energy to the
unhealthy tissue via a first one of the at least one elongate
elements.
38. The method of claim 37, wherein a portion of the first one of
the at least one elongate elements extends distally of a distal end
of the elongated catheter tube.
39. A method for cutting tissue or other material from a body of a
patient, comprising: advancing a catheter to a position in a body
of a patient, the catheter having an elongated catheter tube, the
elongated catheter tube having at least one elongate element
extending along the elongated catheter tube to control movement of
a distal end of the elongated catheter tube, the elongated catheter
tube further having an optical element extending along the
elongated catheter tube, a first one of the at least one elongate
elements being configured to transmit radio frequency energy, and
delivering radio frequency energy from the first one of the at
least one elongate elements to cut the tissue or other
material.
40. The method of claim 39, wherein a portion of the first one of
the at least one elongate elements extends distally of a distal end
of the elongated catheter tube.
41. The method of claim 40, further comprising simultaneously
viewing the portion of the first one of the at least one elongate
elements using the optical element while delivering the radio
frequency energy from the first one of the at least one elongate
elements.
42. The method of claim 39, wherein the tissue to be cut is the
sphincter.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to medical devices, and in
particular to a fiber optic catheter with imaging capabilities.
BACKGROUND OF THE INVENTION
[0002] An endoscope is a piece of surgical equipment that has
imaging capabilities so as to be able to provide images of an
internal body cavity of a patient. Most minimally invasive surgical
procedures performed in the gastrointestinal (GI) tract or other
internal body cavities are accomplished with the aid of an
endoscope. An endoscope includes one or more working channels
through which other medical catheters/instruments can pass.
Typically, an endoscope is used to reach an area of interest within
a body cavity and, thereafter, another instrument such as a
surgical catheter is extended through the working channel of the
endoscope to perform some desired procedure. An endoscope, however,
typically has a diameter that is relatively large with respect to
the body cavity or body lumen through which it must pass.
[0003] A need exists for smaller-diameter devices with imaging
capability. Preferably, such smaller-diameter devices are steerable
so that a physician can readily obtain an image of a location of
interest within the body cavity.
SUMMARY OF THE INVENTION
[0004] The present invention is a smaller-diameter device with
imaging capability involving a single optical fiber or an optical
fiber bundle. In one embodiment, an optical fiber or fiber bundle
with imaging capability is received axially through a lumen of a
steerable catheter. Such a catheter typically includes a single
steering cable, a distal end of which is attached to the distal end
of the catheter. By manipulating the proximal end of the steering
cable, a physician can bend the distal end of the catheter to
thereby steer the catheter. A steerable catheter with a single
steering cable, however, can bend only in one direction. Thus, to
bend the catheter in any desired direction in a three-dimensional
space, the catheter must be axially rotated so that the
one-directional bend will point in the desired direction.
Consequently, the steerable catheter incorporating an optical fiber
is subjected to repeated torque that twists and potentially damages
the fiber.
[0005] To overcome the foregoing disadvantage in some applications,
the present invention further offers a steerable imaging catheter
including a fiber optic cable, which is configured to minimize the
application of undesirable torque to the fiber optic cable. To
achieve this goal, in one embodiment, a steerable imaging catheter
uses at least two cables that bend and steer the catheter. The use
of multiple steering cables reduces the need for axially rotating
the catheter to achieve a desired bend, and therefore minimizes
unduly twisting and damaging the fiber optic cable. In another
embodiment of the present invention, a steerable imaging catheter
is formed of a catheter tube that has greater flexibility near its
distal end portion and has greater stiffness (column strength) in
the remainder of the tube. This construction concentrates any
flexing and also some torque application at the distal end portion
of the tube, while minimizing undue twisting of the tube including
the fiber optic cable in the remainder of the tube.
[0006] Specifically, according to one embodiment of the present
invention, a steerable imaging catheter is provided, including an
elongated catheter tube, at least two steering cables extending
along the catheter tube to control the movement of the distal end
of the catheter tube, and a fiber optic cable extending through the
catheter tube. The catheter may be an imaging-only catheter whose
sole function is imaging, or may be any diagnostic/therapeutic
catheter having a diagnostic/therapeutic function (e.g., a balloon
catheter, stent delivery catheter, sphincterotomy catheter, etc.)
in addition to the imaging function. The fiber optic cable
transmits illumination light from its proximal end to its distal
end and further transmits an image from its distal end to its
proximal end. The diameter of the steerable imaging catheter is
generally between 1 mm and 4.5 mm, which is smaller than that of a
conventional endoscope to permit visualization of a body
cavity/lumen that typically cannot be reached by an endoscope. The
use of multiple steering cables to control the distal end of the
catheter tube permits bending of the distal end in various (two or
more) directions in varying degrees. This feature not only prevents
undue twisting of the fiber optic cable, but also adds to the
maneuverability of the catheter tube, and further significantly
increases the range of view of the fiber optic cable.
[0007] According to another embodiment of the present invention, a
steerable imaging catheter is provided, including an elongated
catheter tube, at least one steering cable extending along the
catheter tube to control the movement of the distal end of the
catheter tube, and a fiber optic cable extending through the
catheter tube. As before, the catheter may be an imaging-only
catheter whose sole function is imaging, or may be any
diagnostic/therapeutic catheter having a diagnostic/therapeutic
function in addition to the imaging function. The catheter tube is
constructed so as to have greater flexibility near its distal end
portion while having greater stiffness in the remainder of the
tube. This may be accomplished, for example, by varying the
durometer rating of the materials used to form the catheter tube.
Such construction concentrates the flexing at the distal end
portion, rather than throughout the entire catheter tube, to
thereby reduce undue twisting of the catheter tube along its entire
length, and further to permit better control of the movement of the
distal end portion.
[0008] According to one embodiment of the invention, a catheter
tube defines a plurality of lumens extending therethrough, and one
of the lumens receives the fiber optic cable. The other lumens may
receive irrigation/sufflation fluid or other devices or equipment.
In one embodiment, the other lumen may receive a measuring probe
therethrough. The measuring probe includes incremental or numerical
markings provided at its distal end portion. By placing the
incremental markings and an object to be measured in the field of
view of the fiber optic cable, a physician can visually measure the
size of the object in reference to the incremental markings.
[0009] According to another embodiment of the invention, the other
lumen may receive a cutting device such as a cutting wire for
delivering RF energy. A physician can deliver the cutting wire and
the fiber optic cable through the catheter tube into the body
cavity, observe any undesirable material (tissue, stone, etc.)
using the fiber optic cable, and then deploy the cutting wire to
deliver RF energy to the undesirable material to cut it out while
observing the cut-out operation using the fiber optic cable.
[0010] According to another embodiment of the invention, the fiber
optic cable and/or the catheter tube are coated with hydrophilic
material.
[0011] According to yet another embodiment of the invention, the
fiber optic cable may be used to carry out an optical
diagnostic/treatment procedure, such as an optical biopsy.
[0012] According to still another embodiment of the invention, the
fiber optic cable is integrally formed with the catheter tube.
[0013] According to a further embodiment of the invention, the
catheter tube is configured to be separable from the fiber optic
cable so as to be discarded after each use, while the fiber optic
cable may be retained for reuse.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] The foregoing aspects and many of the attendant advantages
of this invention will become more readily appreciated as the same
become better understood by reference to the following detailed
description, when taken in conjunction with the accompanying
drawings, wherein:
[0015] FIG. 1 is a block diagram illustrating a steerable imaging
catheter formed in accordance with the present invention together
with related equipment;
[0016] FIG. 2 is a cross sectional view of a catheter tube of a
steerable imaging catheter formed in accordance with the present
invention;
[0017] FIGS. 2A and 2B are radial cross sectional views cut along
lines A-A and B-B, respectively, of FIG. 2;
[0018] FIG. 3 is a radial cross sectional view of a catheter tube
including four steering cables, formed in accordance with an
embodiment of the present invention;
[0019] FIG. 4 is a radial cross sectional view of a catheter tube
including three steering cables, formed in accordance with an
embodiment of the present invention;
[0020] FIG. 5 is a radial cross sectional view of a catheter tube
including two additional lumens, formed in accordance with the
present invention;
[0021] FIG. 6 is a schematic view of the billary system in which a
steerable imaging catheter of the present invention is introduced
via an endoscope; and
[0022] FIG. 7 illustrates a steerable imaging catheter of the
present invention used in conjunction with a measuring probe for
measuring the size or distance of object(s) in the field of
view.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0023] FIGS. 1-3 illustrate a steerable imaging catheter 10 formed
in accordance with the present invention. The catheter 10 includes
an elongated catheter tube 12 having a proximal end 14 and a distal
end 16. The catheter 10 may be an imaging-only catheter, whose sole
function is imaging, or may be any diagnostic/therapeutic catheter
having some diagnostic/therapeutic function in addition to the
imaging function (e.g., a balloon catheter, stent delivery
catheter, sphincterotomy catheter, etc.). Referring specifically to
FIGS. 2, 2A, 2B, and 3, four steering cables 18 are positioned at
equal distances around the circumference of the catheter tube 12,
and extend along the length of the catheter tube 12 substantially
from the proximal end 14 to the distal end 16. The steering cables
18 of the catheter tube 12 control the movement of the distal end
16 of the catheter tube. The catheter 10 also includes a fiber
optic cable 20 having a proximal end 22 and a distal end 24, which
extends at least partially along the length of the catheter tube
12. To this end, the illustrated embodiment as shown in FIG. 1
includes a breakout unit 21 configured to receive and combine the
catheter tube 12 and the fiber optic cable 20. As will be apparent,
in this embodiment, an outer wall of the catheter tube 12 includes
an opening 19 through which the fiber optic cable 20 enters into
the catheter tube 12 so as to extend through and within the
catheter tube 12. The fiber optic cable 20 is configured to
transmit illumination light from its proximal end 22 to the distal
end 24, and also to transmit an image from its distal end 24 to the
proximal end 22. In the illustrated embodiment, as best shown in
FIG. 2, the fiber optic cable 20 includes one or more centrally
extending coherent imaging fibers 20a and one or more
circumferentially extending illumination fibers 20b (which may not
be coherent) that generally surround the one or more imaging fibers
20a. Further, an objective lens 25 is attached to the distal end of
the one or more imaging fibers 20a.
[0024] Referring specifically to FIG. 1, the four steering cables
18 are coupled to a control housing 26, from which a handheld
controller 27 extends. The control housing 26 includes a number of
actuators coupled to the proximal ends of the steering cables 18.
An operator can manipulate the steering cables 18 using control
signals generated by the handheld controller 27 to steer the distal
end 16 of the catheter tube 12 in order to maneuver the catheter 10
through a body cavity.
[0025] Still referring to FIG. 1, the proximal end 22 of the fiber
optic cable 20 may be connected to an eyepiece 23. The eyepiece 23
includes a light splitter 28 and a camera (or image sensor) 29. The
light splitter 28 receives illumination light from a light source
30 through a cable 31. The cable 31 may include a group of standard
clad optical fibers that function as illumination fibers for
carrying the illumination light from the light source 30 to the
light splitter 28. The light from the light splitter 28 is coupled
to the one or more illumination fibers 20b in the fiber optic cable
20 for delivery to the distal end 24 thereof in order to illuminate
the imaged area. An image from the distal end 24 of the fiber optic
cable 20 is transmitted through the one or more imaging fibers 20a
in the fiber optic cable 20 to the proximal end 22 thereof, and
through the light splitter 28 within the eyepiece 23 to the camera
(or image sensor) 29. The image is then processed and supplied from
the camera (or image sensor) 29 via a cable 33 to a camera control
unit 32 coupled to a display (not shown) that displays an image of
the viewed area. Additionally, the eyepiece 23 permits direct
visualization of the viewed area. Still further, a
picture-in-picture unit 34 and a DVD recorder 35 may be provided to
allow a physician to view more than one image at a time on the
display as well as to record images for future review.
[0026] FIG. 2 illustrates an embodiment of a fiber optic cable 20
suitable for use in the present invention. In the illustrated
embodiment, the objective lens 25 and the distal end of the one or
more imaging fibers 20a are connected by a transparent adhesive.
Further, a non-transparent adhesive is applied on the radially
outer surface of the lens 25 and also on the radially outer surface
of the distal portion 20a' of the one or more imaging fibers 20a,
and a first tube 36 is slid thereover to cure the adhesive and to
further bond the lens 25 to the distal end of the one or more
imaging fibers 20a. Then, a non-transparent adhesive is applied on
the radially outer surface of the first tube 36, and a second tube
38 is slid over both the first tube 36 and the one or more imaging
fibers 20a. The one or more illumination fibers 20b are arranged
radially outward of the second tube 38 and are impregnated with a
transparent adhesive. A protecting tube 40 is then slid over the
length of the impregnated illumination fibers 20b. In one
embodiment, the diameter of the lens 25 is 0.35 mm and the overall
diameter of the fiber optic cable 20 is 0.78 mm, though the various
dimensions of the fiber optic cable 20 are not so limited as should
be apparent to one skilled in the art. A suitable fiber optic cable
of this type for use in the present invention is available from
POLYDIAGNOST GmbH of Germany (www.polydiagnost.com). It should be
understood that other types of fiber optic cables having light
illumination and image transmission capacities may also be used, as
will be apparent to one skilled in the art.
[0027] While the illustrated embodiment includes the lens 25 to
focus an image for transmission through the one or more imaging
fibers 20a, a lens may be omitted in some applications. For
example, the distal ends of the one or more imaging fibers 20a
themselves may be tapered so as to internally focus an image
without an additional lens.
[0028] Referring again to FIGS. 2, 2A, 2B, and 3, the catheter tube
12 according to one embodiment of the present invention includes a
lumen 42 extending axially centrally therethrough for receiving the
fiber optic cable 20. In the illustrated embodiment, the
cylindrical wall portion of the catheter tube 12 surrounding the
lumen 42 defines four channels 44 that extend axially through the
catheter tube 12. Each channel 44 receives a steering cable 18. In
the illustrated embodiment, the four channels 44 are equiangularly
provided along the periphery of the catheter tube 12, though the
arrangement of the channels 44 may vary depending on each
application. Further alternatively, referring to FIG. 4, three
channels 44 may be provided, perhaps also equiangularly as
illustrated, for each receiving a steering cable 18. Still
alternatively, only one or two channels 44 may be provided, or five
or more channels 44 may be provided for each receiving a steering
cable 18, depending on the degree of maneuverability of the distal
end 16 of the catheter tube 12 as required in each application.
[0029] The steering cables 18 extend freely through the channels 44
from the proximal end 14 to the distal end 16 of the catheter tube
12. Alternatively, the channels 44 may extend only partially, for
example to a position near the distal end 16 of the catheter tube
12 to ensure a fixed spacing between the steering cables 16 at the
distal end 16. In such a case, the steering cables 18 toward the
proximal end 14 of the catheter tube 12 may extend freely through a
generally annular space around the fiber optic cable 20 (without
being confined within any channels 44). In any case, the distal
ends of the steering cables 18 are secured to the distal end 16 of
the catheter tube 12 using suitable means, such as by adhesive,
soldering, anchoring, or by using a suitable fastener.
[0030] Referring back to FIG. 1, an embodiment of the control
housing 26 including various electromechanical actuating elements
for controlling (i.e., pulling and releasing) the steering cables
18a is illustrated. The housing 26 includes four actuators, such as
servo motors 46 each coupled to a spool (not shown) adopted to be
secured to the proximal end of a steering cable 18. The servo
motors 46 can be selectively activated to rotate the spool in
either direction so as to wind up or release the steering cable 18.
If three steering cables 18 are used, then three servo motors 26
may be used. Further alternatively, only one servo motor may be
used to control two steering cables that are wound in two opposite
directions on a single spool. In this case, two servo motors 26 may
be used to control total four steering cables 18. The servo motors
46 are controlled by a servo controller 48 which, via a controller
interface 50, receives control signals from the handheld controller
27. In one embodiment, the handheld controller 27 may be formed as
a joystick, which an operator can tilt in the direction in which
the operator wants the distal end 16 of the catheter tube 12 to
tilt. Alternatively, the handheld controller 27 may be formed of
operable buttons, knobs, dials, switches, or a computer keyboard.
Using the handheld controller 27, the operator can maneuver the
distal end 16 of the catheter tube 12 within the patient's body
cavity, while at the same time observing the image received at the
distal end 16 of the catheter tube 12, either directly via the
eyepiece 23 or indirectly on the screen (not shown). Some examples
of the configuration and operation of a cable control system using
the servo motors 46 are disclosed in co-pending U.S. patent
application Ser. Nos. 10/406,149, filed Apr. 1, 2003, and
10/811,781, filed Mar. 29, 2004, which are incorporated herein by
reference. Alternatively to the embodiments using the servo motors
46, the steering cables 18 may be manipulated by various other
mechanisms including, but not limited to, linear actuators, cams,
torsion-application means, etc. Further alternatively, the steering
cables 18 may be manually manipulated, as in manipulating a puppet,
though a manual operation may be often cumbersome and thus may not
be desirable.
[0031] Regardless of the particular means employed to control the
steering cables 18, pulling one of the steering cables 18 results
in the distal end 16 of the catheter tube 12 to bend in the
direction of the pulled steering cable 18, while releasing this
steering cable 18 results in the distal end 16 of the catheter tube
12 to return to its normal position (shape). Therefore, by
selectively pulling (or releasing) each of the steering cables 18
at their proximal ends, using the handheld controller 27 for
example, a physician can have the distal end 16 of the catheter
tube 12 to bend (or bow) in various directions and in varying
degrees. This permits a physician to better control the maneuvering
of the catheter tube 12 and hence the imaging catheter 10 through a
tortuous pass in the body cavity, without unduly twisting and
damaging the fiber optic cable 20. Further, the use of multiple
cables to control the distal end significantly increases the range
of view of the fiber optic cable 20.
[0032] The catheter tube 12 is formed of any suitable flexible
material including, but not limited to, extruded plastic such as
polytetrafluoroethylene (PTFE, Teflon.RTM.), polyether block amide,
nylon, or a combination or blend of these. If strength is required,
the catheter tube 12 may be formed of, or may be reinforced by
including an additional layer formed of, over-extruded plastic,
metal coil, mesh, stainless steel hypotube, etc.
[0033] According to a preferred embodiment of the present
invention, the distal portion of the catheter tube 12
(approximately 1-2 inches where the flexing occurs) is made more
flexible (i.e., less stiff) than the remainder of the catheter tube
12. This serves to concentrate the flexing at the distal end
portion rather than throughout the entire catheter tube, to achieve
the desired motion (steering) of the catheter tube 12 while
minimizing undue twisting of the entire catheter tube. Varying
flexibility can be provided by various methods, such as by varying
the durometer rating of materials that form the catheter tube 12,
by varying the spacing between components (e.g., coil rings) that
form or reinforce the catheter tube 12 along the length of the tube
12, etc. For example, by arranging coil rings relatively far apart
from each other at a distal end portion of a catheter tube while
arranging coil rings closer together in the remainder of the tube,
a catheter tube having increasing flexibility toward its distal end
can be obtained. In some embodiments, the flexibility may be varied
along the length of a tube in two stages to form a tube consisting
of a more flexible distal end portion and a less flexible remainder
portion. In other embodiments, the flexibility may be varied
gradually (e.g., increasingly) throughout the length of a catheter
tube from its proximal end to its distal end. Some methods of
varying the flexibility (or stiffness) of a catheter tube along its
length are described in detail in U.S. patent application Ser. Nos.
10/406,149 and 10/811,781, incorporated above.
[0034] The catheter tube having varying flexibility may be used in
combination with two or more steering wires to control the distal
end thereof. Alternatively, it may be used with a single steering
wire, and still achieves desired control of the distal end thereof
while minimizing undue twisting of the entire length of the
tube.
[0035] According to some embodiments of the present invention, the
overall diameter of the steerable imaging catheter 10 is from about
1.0 mm to about 4.5 mm. This range is comparable to the diameter of
a conventional therapeutic/diagnostic catheter and is smaller than
that of a conventional endoscope, to permit visualization of a body
cavity/lumen that typically cannot be reached by an endoscope.
[0036] In one embodiment, the catheter tube 12 may be manufactured
specifically to be disposable, using relatively inexpensive plastic
material such as medical grade polyurethane. A disposable catheter
tube is advantageous in that no sterilization of a catheter is
required after each use. Once a surgical operation is completed,
the fiber optic cable 20 (reusable) may be simply removed from the
catheter tube 12 and the catheter tube 12 (perhaps including the
steering cables 18) may be discarded. In order to protect and
isolate the reusable fiber optic cable 20 from external elements
during use, the distal end 16 of the disposable catheter tube 12
may include a transparent sealing cover.
[0037] According to one embodiment of the present invention, the
exterior surface of the catheter tube 12 may be coated with
lubricous, for example hydrophilic material so as to facilitate the
placement of the catheter tube 12 inside a patient's anatomy.
Additionally or alternatively, the exterior surface of the fiber
optic cable 20 may be coated with lubricous, hydrophilic material
so as to reduce friction and facilitate the placement of the fiber
optic cable 20 through the catheter tube 12, in particular when the
fiber optic cable 20 (reusable) is to be used with a disposable
catheter tube 12, as described above. In some applications,
hydrophilic material should be reusable so as to retain its
hydrophilic properties through multiple uses (and perhaps also to
withstand sterilization at least for several times). Suitable
hydrophilic coating material includes polytetrafluoroethylene
(PTFE) based material, such as those available under the trademarks
of Hydropass.TM. and Endoglide.TM. from Boston Scientific
Corporation of Natick, Mass. (www.bsci.com), described in U.S. Pat.
Nos. 5,702,754 and 6,048,620, which are herein incorporated by
reference. The thickness of the coating on the fiber optic cable 20
must be thin enough to permit the fiber optic cable 20 to pass
through the catheter tube 12 having a specific diameter (which in
turn is limited by the dimensions of the patient's anatomy), and at
the same time must be thick enough to withstand abrasion and other
damages. The thickness of the coating on the catheter tube 12 may
be similarly determined. Coating may be applied using various
methods as will be apparent to one skilled in the art, such as by
dipping the fiber optic cable 20 (or the catheter tube 12) in the
coating material, or spraying, painting, or printing the coating
material on the fiber optic cable 20 (or the catheter tube 12).
[0038] According to one embodiment of the present invention, the
fiber optic cable 20 is integrally formed with the catheter tube 12
by various means, such as by over-extruding a plastic material over
the fiber optic cable 20, by adhesive, or by heat-shrinking the
catheter tube 12 around the fiber optic cable 20. This will prevent
removal of the fiber optic cable 20 from the catheter tube 12,
which may be desirable in some applications. In such an embodiment,
the distal end(s) of one or more control cables 18 may be attached
directly to the distal end of the fiber optic cable 20. If the
catheter tube 12 is intended to be disposable, as described above,
then the fiber optic cable 20 integrally formed therein will also
be discarded together with the catheter tube 12 after each use.
Alternatively, the catheter tube 12 integrally including the fiber
optic cable 20 may be built for repeated use and sterilization.
[0039] Referring to FIG. 5, the catheter tube 12 of the steerable
imaging catheter 10 may further include one or more additional
lumens 51, 52 to axially extend therethrough. These additional
lumens 51, 52 may receive any fluid (for irrigation and sufflation
purposes, for example), or other devices and equipment, such as a
cutting device including a cold cutting device and a cutting wire
that delivers RF energy. The deployment of any of these additional
devices and equipment may also be controlled by the handheld
controller 27, or may be independently controlled, as should be
apparent to one skilled in the art.
[0040] For example, referring to FIG. 6, the steerable imaging
catheter 10 including an additional lumen (51 or 52) through which
a cutting wire 54 extends, is used in conjunction with an endoscope
(e.g., duodenoscopy) 55. The endoscope 55 is advanced into a
patient's billary system until the distal end 56 thereof is
positioned near the sphincter of oddi within the duodenum (at the
bottom of the stomach), as illustrated. Then, a physician advances
the steerable imaging catheter 10 of the present invention through
a lumen of the endoscope 55 and through the sphincter to enter the
common bile duct and pancreatic duct 57, perhaps by manipulating
the handheld controller 27 to controllably bend the distal end 16
of the catheter tube 12. Once in place in the bile duct, a
physician deploys the cutting wire 54 at the distal end 16 of the
catheter tube 12. The cutting wire 54 delivers RF energy to the
tissue in order to cut the sphincter, thereby allowing the removal
of stones or other objects from the patient's gallbladder. At the
same time, the fiber optic cable 20 within the imaging catheter 10
allows a physician to view tissue further in the bile duct for
diagnosis or treatment. In this regard, according to one embodiment
of the present invention, the fiber optic cable 20 freely extends
through the lumen 42 of the catheter tube 12 so as to extend (or
protrude) further from the distal end 16 of the catheter tube 12,
to thereby additionally advance into a smaller-diameter area. The
deployment of the fiber optic cable 20 may also be controlled by
the handheld controller 27, or may be independently controlled, as
should be apparent to one skilled in the art. In this
configuration, a tapered system is formed starting with the
endoscope 55, which slidably includes the steerable imaging
catheter 10, which in turn slidably includes the fiber optic cable
20.
[0041] In one embodiment, one of the steering cables 18 may
additionally serve as the cutting wire for delivering RF energy. In
this embodiment, the distal end portion of the steering cable 18 is
exposed to the outside of the catheter tube 12 so as to be able to
contact the undesirable material to be removed.
[0042] A steerable imaging catheter of the present invention may be
passed through a working lumen of an endoscope, as described above,
or may be passed through a working lumen of a non-endoscope device
(e.g., biopsy forceps). Furthermore, a steerable imaging catheter
of the present invention may be introduced into a body cavity of a
patient adjacent to a non-endoscope device, either completely
separately, or in combination such as by a snap-on type bracket
provided on the side of the non-endoscope device that contains but
not necessarily constrains the steerable imaging catheter.
[0043] The one or more additional lumens 51, 52 provided through a
catheter tube 12 of an imaging catheter 10 may also receive a
measuring probe. FIG. 7 illustrates that the additional lumen 51
slidably receives an elongated measuring probe 66. As before, the
lumen 42 of the catheter tube 12 receives the fiber optic cable 20
therethrough, although in the illustrated embodiment the lumen 42
is not centrally defined through the catheter tube 12 unlike in the
previously described embodiments. The measuring probe 66 is used in
conjunction with the fiber optic cable 20 to measure the size or
distance of objects within the patient's anatomy, such as the size
of stones, sphincters, or tissue (a stone 68 is shown in FIG. 7).
To this end, the measuring probe 66 includes high-contrast, perhaps
color-coded incremental or numerical markings 69 at its distal end
portion. Different types of markings will indicate distance such as
larger marks for significant distances and smaller marks for lesser
distances. Also, alternate colors may be used to identify specific
distances. For example, a green band may be 1 mm wide, followed by
a red band that is also 1 mm wide. This would allow the observer to
readily see the 2 mm total transition from 1 mm-red to 1 mm-green
and estimate the total distance accordingly. The markings 69 may
also include spots or dots that are of specific diameters or
distances from one another. Additionally or alternatively, the
markings 69 may indicate a specific size/distance, which readily
indicates to a physician that anything bigger than (or smaller
than) this specific size/distance is of concern, for example.
Further alternatively, the markings 69 may be in the form of a
spiral/helical pattern so that, when they are axially moved, they
readily indicate the direction of movement to the observing
physician.
[0044] The probe 66 may be made of any suitable material flexible
enough to pass through a patient's anatomy and yet rigid enough to
permit reading of the markings 69.
[0045] The incremental markings 69 provide a reference against
which an object (e.g., stone 68) in the viewing field of the
steerable imaging catheter 10 can be compared. Specifically, in
operation, a physician places the incremental markings 69 provided
at the distal portion of the measuring probe 66 relative to the
fiber optic cable 20 so that both the object (e.g., stone) 68 and
the markings 69 will be in the field of view 70. Then, the
physician, using the fiber optic cable 20, visually measures the
size of the object 68 in reference to the incremental markings 69
of the measuring probe 66. In this regard, in order to deliver the
fiber optic cable 20 and the measuring probe 66 generally in tandem
to the body cavity of interest, as illustrated, one embodiment of
the catheter tube 12 defines two lumens arranged in a generally
side-by-side configuration: the lumen 42 for receiving the fiber
optic cable 20; and the additional lumen 51 for receiving the
measuring probe 66. In one embodiment, to strictly maintain the
tandem configuration, both the fiber optic cable 20 and the
measuring probe 66, in a relative tandem configuration, may be
fixedly secured in the catheter tube 12. Alternatively, in another
embodiment, the fiber optic cable 20 and/or the measuring probe 66
freely extend through the catheter tube 12.
[0046] In accordance with one embodiment, the fiber optic cable 20
itself may be provided with the markings 69 near its distal end,
which can then be viewed by another device having imaging
capability (e.g., another fiber optic cable 20). Alternatively, the
markings 69 may be provided on a portion of the fiber optic cable
20 near its proximal end, which does not enter the patient's body.
In this embodiment, a physician can measure a distance/size by
directly counting the proximal markings 69 (outside the patient's
body) while inserting or pulling the fiber optic cable 20 in and
out of the patient.
[0047] In accordance with one embodiment of the present invention,
the fiber optic cable 20 may be configured to transmit
electromagnetic energy (including both visible and non-visible
ranges) for further diagnosis/treatment purposes. For example, to
perform an optical biopsy, a suitable diagnostic system (72 in FIG.
1) is provided, including software for processing the signals
received via the fiber optic cable 20 to make a diagnosis. As a
specific example, based on the fact that cancerous and necrotic
tissue has a different density and thus absorbs a different
wavelength of light than healthy tissue, the fiber optic cable 20
can be used to irradiate light of a certain wavelength range on the
tissue in question, and then to read the light reflected back from
the tissue. The diagnostic system 72 contains software to subtract
the reflected light from the irradiated light to determine the
wavelength of the light that was absorbed by the tissue, thereby
making a diagnosis of the tissue. Other optic-based diagnostic
techniques may also be used with the fiber optic cable 20, as
should be apparent to one skilled in the art, such as
interferometry, induced or natural fluorescence, and Rayleigh
scattering. Another example of a suitable technique is the laser
Raman spectroscopy as applied in tissue or bloodstream.
Specifically, a given tissue will have signature intensity peaks at
a specific Raman shift interval or range of intervals. Mapping or
scanning known healthy tissue for Raman shift to develop a database
for comparison will enable clinicians to compare an arbitrary Raman
scan of tissue for abnormalities. Similarly, Raman scans of known
unhealthy or cancerous tissues may be used to be compared to an
arbitrary Raman scan to predict disease state (malignant or
benign). The prediction may aid in the decision to take tissue
samples for further testing. Any optical biopsy method can be used
to make instant diagnosis of tissue without having to remove a
biopsy sample of tissue from the patient.
[0048] While the preferred embodiments of the invention have been
illustrated and described, it will be appreciated that various
changes can be made therein without departing from the scope of the
invention.
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