U.S. patent application number 12/708177 was filed with the patent office on 2010-08-19 for catheter introducer system for exploration of body cavities.
This patent application is currently assigned to Boston Scientific Scimed Inc.. Invention is credited to Jeffrey Michael Wendlandt.
Application Number | 20100210906 12/708177 |
Document ID | / |
Family ID | 23956293 |
Filed Date | 2010-08-19 |
United States Patent
Application |
20100210906 |
Kind Code |
A1 |
Wendlandt; Jeffrey Michael |
August 19, 2010 |
CATHETER INTRODUCER SYSTEM FOR EXPLORATION OF BODY CAVITIES
Abstract
A catheter introducer system for endoscopy is disclosed which
includes a steering section and a propulsion section located near
the end of the catheter that is introduced in a body cavity, and a
non-collapsible sheath defining a working channel, disposed inside
the catheter, extending substantially from the proximate to the
distal end and maintaining a substantially circular cross-section
even when bent along an axis. The propulsion section is designed to
pull the rest of the catheter inside the body cavity, so there is
no need to push the catheter along. The catheter can thus be made
very flexible in bending, and a larger diameter catheter can be
used without discomfort to the patient.
Inventors: |
Wendlandt; Jeffrey Michael;
(Newton, MA) |
Correspondence
Address: |
FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER;LLP
901 NEW YORK AVENUE, NW
WASHINGTON
DC
20001-4413
US
|
Assignee: |
Boston Scientific Scimed
Inc.
|
Family ID: |
23956293 |
Appl. No.: |
12/708177 |
Filed: |
February 18, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11429281 |
Jun 26, 2006 |
7699771 |
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12708177 |
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10282211 |
Oct 29, 2002 |
7066880 |
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11429281 |
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09492448 |
Jan 27, 2000 |
6517477 |
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10282211 |
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Current U.S.
Class: |
600/114 |
Current CPC
Class: |
A61B 1/00156 20130101;
A61B 1/0057 20130101; A61M 2210/1042 20130101; A61B 1/00094
20130101; A61B 1/01 20130101; A61M 25/0116 20130101; A61B 1/00082
20130101; A61B 1/0058 20130101; A61B 1/00147 20130101; A61B 1/31
20130101; A61B 1/053 20130101; A61B 1/2733 20130101; A61B 1/018
20130101 |
Class at
Publication: |
600/114 |
International
Class: |
A61B 1/00 20060101
A61B001/00 |
Claims
1.-25. (canceled)
26. A catheter comprising: a flexible tube having a distal end and
a proximal end, wherein the tube defines a working channel therein;
a steering section disposed adjacent to the distal end of the tube,
adapted for pointing the distal end of the tube in a desired
direction; and a propulsion section disposed adjacent the distal
end of the tube for pulling the tube through a body cavity, the
propulsion section including a plurality of gripping members each
having a surface adapted for selectively attaching to tissue in an
inner portion of the body cavity, the plurality of gripping members
being disposed on an outer surface of the tube and slidably movable
relative to the tube.
27. The catheter according to claim 26, wherein the surfaces of the
plurality of gripping members include a plurality of suction
holes.
28. The catheter according to claim 27, wherein the plurality of
suction holes are interspersed between a plurality of protrusions
extending from an outer surface of the plurality of gripping
members.
29. The catheter according to claim 26, wherein the surfaces of the
plurality of gripping members are recessed with respect to adjacent
portions of the outer surface of the tube.
30. The catheter according to claim 26, wherein the surfaces of the
plurality of gripping members extend radially outwardly of the
outer surface of the tube.
31. The catheter according to claim 26, wherein the plurality of
gripping members are spaced circumferentially around the tube.
32. The catheter according to claim 26, wherein the steering
section includes a flexible structure and control wires attached to
the distal end of the tube, the control wires being each
independently extendable and retractable.
33. A catheter comprising: a flexible tube having a distal end and
a proximal end, wherein the tube defines a working channel therein;
a steering section disposed adjacent the distal end of the tube,
adapted for pointing the distal end of the tube in a desired
direction; and a plurality of gripping members disposed on an outer
surface of the tube adapted to selectively grip an inner portion of
a body cavity, the plurality of gripping members being each
independently movable relative to the tube so as to propel the tube
within the body cavity.
34. The catheter according to claim 33, wherein the plurality of
gripping members move in a direction substantially parallel to a
length of the tube.
35. The catheter according to claim 33, wherein the plurality of
gripping members are spaced circumferentially around the tube.
36. The catheter according to claim 33, wherein the plurality of
gripping members are balloons adapted to selectively grip the inner
portion of the body cavity when inflated.
37. The catheter according to claim 33, wherein the plurality of
gripping members are pads having suction ports adapted for gripping
the inner portion of the body cavity by applying suction to the
inner portion of the body cavity.
38. The catheter according to claim 34, wherein the steering
section includes a flexible structure and control wires attached to
the distal end of the tube, the control wires being each
independently extendable and retractable.
39. The catheter according to claim 38, wherein the flexible
structure is one of a flexible mesh or a bellows.
40. A catheter comprising: a flexible tube having a length
extending from a distal end to a proximal end; a working channel
defined within the tube, adapted for guiding a medical tool along
through the tube; a propulsion section of the tube disposed
adjacent the distal end, adapted for pulling the tube through a
body cavity; and a steering section of the tube disposed adjacent
the distal end, wherein the steering section has a perimeter
surface and includes a steering mechanism disposed around the
perimeter surface for pointing the distal end in a desired
direction.
41. The catheter of claim 40, wherein the steering mechanism
includes an expandable structure and a plurality of wires
circumferentially disposed along a length of the expandable
structure, the plurality of wires being adapted to be individually
extended and retracted to point the distal end in a desired
direction.
42. The catheter of claim 41, wherein the expandable structure is
one of a flexible mesh and a bellows.
43. The catheter of claim 41, wherein the plurality of wires are
attached to the expandable structure by sutures.
44. The catheter of claim 41, wherein the propulsion section
includes a plurality of gripping members each having a surface
adapted for selectively attaching to tissue in an inner portion of
the body cavity, the plurality of gripping members being disposed
on an outer surface of the tube.
45. The method of claim 44, wherein the plurality of gripping
members are independently movable relative to the tube.
Description
RELATED APPLICATIONS
[0001] This is a Continuation of U.S. patent application Ser. No.
10/282,211, filed Oct. 29, 2002, which is a continuation of U.S.
patent application Ser. No. 09/492,448, filed on Jan. 27, 2000, now
U.S. Pat. No. 6,517,477.
BACKGROUND OF THE INVENTION
[0002] The present invention relates to a method and a device for
performing endoscopy through a catheter introducer system. In
particular, the present invention relates to a catheter introducer
system for endoscopy designed to reach the cecum portion of the
gastrointestinal tract.
DESCRIPTION OF RELATED ART
[0003] Endoscopy has become an increasingly important tool in
diagnosing and in treating ailments of the gastrointestinal tract,
also referred to as the GI tract. Typical endoscopes are
essentially formed by a somewhat flexible tube that is pushed
through the GI tract, after being introduced in the body cavity
starting from the rectum or starting from the esophagus. The
endoscope has a steerable tip to facilitate navigation through the
GI tract, and typically has to be sufficiently stiff so that it can
be pushed further along the body cavity. The tip of the endoscope
that is introduced in the GI tract can be outfitted with several
devices, most notably an illumination device and a vision device,
such as a vision integrated circuit, so that the operator of the
endoscope can observe the interior of the GI tract and maneuver the
endoscope in the proper position.
[0004] Once the endoscope is in position, other tools attached to
the endoscope or inserted through the endoscope can be brought to
the proper position in the GI tract. Various procedures can then be
carried out, such as removing polyps, performing sutures,
irrigation, suction, and removing other tissues. The various tools
that are used together with the endoscope can be either inserted
separately in the GI tract and placed in the proper position
independently, or may travel in a working channel of the endoscope,
so that once the endoscope is positioned at the desired location in
the GI tract, the tools inserted in the endoscope will also easily
reach that position.
[0005] Endoscopes or other smaller similar devices can also be used
to explore other body cavities, for example airways or blood
vessels. These probes must be small to fit in the smaller cavities,
and care must be taken to avoid damage to the more fragile
membranes lining these cavities.
[0006] Current state of the art endoscopes are very capable
devices, and endoscopy has been very successful in diagnostic and
therapeutic applications with the use of current endoscopes and the
current arsenal of tools that can be inserted through the working
channel of the endoscope, or can be attached to the outside of the
endoscope. However, current endoscope technology has limitations
and drawbacks. One of the greatest drawbacks of current endoscopes
is that the working channel is small. The working channel is small
relative to overall diameter of the endoscope, and is further
limited by the space taken up by vision, irrigation, suction,
light, and control cabling mechanisms that are part of the
endoscope and are required to control the endoscope. Thus there is
a very small area left for other tools to be introduced through the
endoscope.
[0007] Current endoscopes are also difficult to maneuver,
particularly when the endoscope has to be pushed all the way to a
far portion of the intestine, such as the cecum, located at the
beginning portion of the large intestine. Currently, reaching the
cecum requires training, skill, luck and trial and error on the
part of the operator. Current endoscopes have to be maneuvered by
pushing them inside the gastrointestinal tract, while steering the
far end inside the body cavity. This situation creates an
inherently unstable condition, where a long tube is being pushed
through a narrow cavity. This requires the endoscope tube to be
rather rigid, resulting in discomfort to the patient as the
endoscope is maneuvered. Because of this, the patient often must be
sedated.
[0008] Once the cecum has been reached, additional tools still have
to be navigated through the body to reach the location, and if the
endoscope is withdrawn from that location to make room for other
tools, access has to be reestablished using the same complicated
procedure. Current endoscopes tend to be reusable because of the
high cost of their components, and thus require thorough cleaning
to sterilize them. Sterilization can be difficult to guarantee, and
in many instances a disposable device would be preferable.
[0009] Accordingly, there is a need for an improved type of
endoscope with a introducer system that obviates some of the
drawbacks of currently known endoscopes.
SUMMARY OF THE INVENTION
[0010] The present invention is directed to a catheter introducer
system for endoscopy that substantially obviates one or more of the
problems due to limitations and disadvantages of the related art,
and that can be used more easily and with less discomfort to the
patient. Additional features and advantages of the invention will
be set forth in the description which follows, and in part will be
apparent from the description, or may be learned by practice of the
invention. Other advantages of the invention will be realized and
obtained by the apparatus and method particularly pointed out in
the written description and claims hereof, as well as the appended
drawings.
[0011] To achieve these and other advantages and in accordance with
the purpose of the invention, as embodied and broadly described,
the invention is a catheter introducer system for endoscopy tools,
which includes a flexible tubular catheter defining a working
channel and having a distal end for introduction in a body cavity
and a proximal end opposite to the distal end. The introducer
system also includes a propulsion section disposed adjacent to the
distal end of the catheter and adapted for pulling the catheter
through the cavity, as well as a steering section disposed adjacent
to the distal end of the catheter and adapted for pointing the
distal end in a desired direction. Control means for commanding the
operation of the propulsion section and of the steering section are
also provided. The proximal end of the catheter has an opening to
introduce endoscopy tools in the catheter. The distal end can be
tapered, and has another opening to allow the endoscopy tools to
exit the catheter and be used within the body cavity. A tool
positioning system can also be included in the distal end of the
catheter to position the endoscopy tools. A rigid sheath can be
used at the entrance of the body cavity to surround the flexible
catheter and prevent interference or binding of the flexible
catheter at the entrance point of the cavity.
[0012] In another aspect, the invention is a method for navigating
a catheter introducer for endoscopy in a body cavity by introducing
a distal end of the catheter containing a propulsion section into
the body cavity, attaching a distal gripper portion of the
propulsion section to an inner surface of the body cavity, and
reducing a distance between the distal gripper portion and a
proximate gripper portion of the propulsion section, the proximate
gripper portion being disposed further from the distal end than the
distal gripper portion. The next steps include attaching the
proximate gripper portion and releasing the distal gripper portion
from the inner surface, and increasing the distance between the
distal and the proximate gripper portions to extend the distal end
further in the body cavity.
[0013] In a further aspect, the invention is a method for
navigating a catheter introducer for endoscopy in a body cavity
that includes introducing a distal end of the catheter containing a
propulsion section into the body cavity, disposing a first set of
gripping pads of the propulsion section along a rear
circumferential position of the catheter, and attaching the first
set of gripping pads to an inner surface of the body cavity. This
is followed by disposing a second set of gripping pads of the
propulsion section along a front circumferential position, closer
to the distal end than the rear circumferential position, attaching
the second set of gripping pads to the inner surface, and releasing
the first set of gripping pads from the inner surface. The process
is completed by moving the second set of gripping pads
substantially to the rear circumferential position and then
releasing the second set of gripping pads from the inner
surface.
[0014] It is to be understood that both the foregoing general
description and the following detailed description are exemplary
and explanatory and are intended to provide further explanation of
the invention as claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The accompanying drawings are included to provide a further
understanding of the invention and are incorporated in and
constitute part of the specification, illustrate several
embodiments of the invention and together with the description
serve to explain the present invention. In the drawings:
[0016] FIG. 1 illustrates a first embodiment of the catheter
introducer system for endoscopy according to the invention;
[0017] FIG. 1a illustrates a detail of the proximal end of the
catheter shown in FIG. 1.
[0018] FIG. 2 illustrates a detail of the distal end of the
catheter shown in FIG. 1;
[0019] FIG. 3 illustrates a portion of a second embodiment of the
catheter introducer system according to the invention;
[0020] FIG. 4 illustrates a portion of another embodiment of the
catheter introducer system according to the invention;
[0021] FIG. 5 is a side elevation showing one embodiment of a
steering/propulsion section according to the invention;
[0022] FIG. 6 is a perspective view showing a detail of one
embodiment of a gripper portion;
[0023] FIG. 7 is a front and side view of a first embodiment of a
suction ring according to the invention;
[0024] FIG. 8 is a front, perspective and side view of a second
embodiment of a suction ring according to the invention;
[0025] FIG. 9 is a front, perspective and side view of a third
embodiment of a suction ring according to the invention;
[0026] FIG. 10 is a front and side view of a fourth embodiment of a
suction ring according to the invention;
[0027] FIG. 11 is a front and side view of a fifth embodiment of a
suction ring according to the invention;
[0028] FIG. 12 is a front, perspective and side view of a sixth
embodiment of a suction ring according to the invention;
[0029] FIG. 13 is a front and side view of a seventh embodiment of
a suction ring according to the invention;
[0030] FIG. 14 is a front, perspective and side view of an eight
embodiment of a suction ring according to the invention;
[0031] FIG. 15 is a front, perspective and side view of a ninth
embodiment of a suction ring according to the invention;
[0032] FIG. 15b is a top view of a variation of the embodiment
shown in FIG. 15.
[0033] FIG. 16 is a diagram showing the interaction of body tissue
with a suction hole according to one embodiment of the
invention;
[0034] FIG. 16b is a diagram showing the interaction of body tissue
with a suction hole according to another embodiment of the
invention;
[0035] FIG. 17 is a top and perspective view of a tenth embodiment
of a suction ring according to the invention;
[0036] FIG. 18 is a top view of an eleventh embodiment of a suction
ring according to the invention;
[0037] FIG. 19 is a schematic side view showing the
steering/propulsion section according to one embodiment of the
invention;
[0038] FIG. 20 is a perspective view of a twelfth embodiment of a
suction ring according to the invention; and
[0039] FIG. 21a is a perspective view of a thirteenth embodiment of
a suction ring according to the invention.
[0040] FIG. 21b is a perspective view of a fourteenth embodiment of
a suction ring according to the invention.
DETAILED DESCRIPTION OF THE INVENTION
[0041] The catheter introducer system according to the present
invention consists of a large catheter having an outer diameter
that is customized to fit within the portion of body cavity into
which it is to operate, for example the colon, esophagus, or other
part of the GI tract. The catheter may be customized to the size of
body cavities of individual patients. A steerable tip is included
at the distal end of the catheter that is introduced in the body
cavity, so that the device can easily travel inside the GI tract or
other body cavity that is the subject of the procedure. A
propulsion section is also included near the distal end of the
catheter, that operates by pulling the distal end through the body
cavity, so that the rest of the device is also pulled along. In
this manner, a very flexible catheter tube can be used. A more
flexible catheter results in less discomfort to the patient, and
can thus be made of a larger diameter than a rigid catheter could
be made. The patient also does not have to be sedated for this
procedure.
[0042] The catheter introducer system has several functions,
including navigation and maneuvering in the GI tract, providing
light and vision devices to see the areas surrounding the tip of
the catheter, providing suction, irrigation and tissue extraction,
transporting devices for image acquisition such as optical and
ultrasound sensors, and providing a working channel and tool
manipulation for various endoscopy tools.
[0043] Because of the design of the catheter according to the
present invention, a larger diameter tube can be used, so that a
large working channel is provided for introduction and maneuvering
of other tools used during endoscopic procedures. The propulsion
and steering sections allow the catheter to maneuver easily in the
colon, or in other parts of the GI tract, including hard to reach
parts such as the cecum. Once the catheter is positioned near the
area of the GI tract of interest, it can remain there while various
tools are introduced through the working channel, and thus access
to the affected area of the GI tract can easily be accomplished by
successive and different tools. Many components of this catheter
introducer system are disposable, thus obviating some of the
problems due to difficult sterilization procedures.
[0044] FIG. 1 illustrates a first embodiment of the endoscopy
delivery catheter according to the invention. Catheter introducer
system 1 includes a flexible tubular catheter 2 having a distal end
4 and a proximal end 6. Distal end 4 is the end of the catheter
that is introduced in the body cavity, while proximal end 6 is at
the opposite end from distal end 4 and remains outside of the body
cavity. Flexible catheter 2 is hollow on the inside, thus defining
a working channel 10 that extends from proximal end 6 to distal end
4. Since the catheter 2 is very flexible, it can have a large
diameter, so that a large working channel 10 is provided for
introduction and maneuvering of endoscopy tools 8.
[0045] In a preferred embodiment, the working channel is defined by
a sheath 11, which is non-collapsible and thus tends to maintain a
circular cross section even when it is bent along its axis. Sheath
11 can also include a coil to help maintain its cross sectional
shape. The working channel tends to retain a constant size when
sheath 11 is used, so that binding of the tools inserted in the
working channel 10 is prevented, and the outer surface of catheter
2 can be very light and flexible. For example, the working channel
can have a diameter of about 14 mm, resulting in an outer diameter
of the device of about 20 mm.
[0046] Various types of tools 8 can be inserted through the working
channel 10, so that once catheter 2 is in position within the body
cavity, additional endoscopy tools can quickly and easily reach the
area of interest within the GI tract. Any present tool for
endoscopy can be adapted for use in the working channel 10 of
catheter 2, and the large cross section of working channel 10 opens
the possibility of developing new tools and procedures that can
improve the function of current devices. In a preferred embodiment,
the catheter portion 2 can be disposable, so that cleanliness and
sterilization of the catheter introducer system can be assured.
[0047] In addition to tools 8 that can be introduced through the
catheter introducer system 1, some other devices can be built-in
within catheter 2. For example, a vision chip 12 such as a charge
coupled device (CCD) or a CMOS and light source 14 can be built in
the catheter, as well as an accessory 16 that may perform suction,
irrigation, or other functions. In addition to a vision chip 12,
other sensors could be provided on the catheter introducer system
1. For example, X-ray or ultrasound sensors could be utilized.
[0048] In a preferred embodiment, vision chip 12 and light source
14 can be part of a modular vision tool 13 that can be detached
from catheter 2 and replaced. For simplicity, vision tool 13 could
snap in place at the front of catheter 2, so that electrical or
other connections would be made automatically. Using a snap-on
vision tool 13 facilitates sterilization of the device, because
most components of the catheter introducer system 1 other than
vision tool 13 could be made disposable. If a CCD is used in vision
tool 13, only thin wires need to connect the CCD to the proximate
end of the catheter 2. Catheter 2 thus remains flexible and can be
manufactured cheaply. If necessary, a fluid supply could be
provided to the CCD lens, to clean it of contaminants.
[0049] The catheter portion can be provided with a rectal sheath 20
made of a more rigid material and located at the entrance of the
body cavity, for example to prevent the sphincter from compressing
and binding the flexible catheter. Sheath 20 is designed to
maintain the sphincter in an open position and allow the catheter
to move back and forth freely. The sheath may also provide a seal
with the outer surface of the catheter. This seal is particularly
useful when air is used to inflate the colon, to facilitate the
visual inspection. In a further embodiment according to the
invention, an active sheath can be used to assist the motion of the
catheter, by pushing and pulling on the catheter. The means to move
the catheter axially and rotationally may be, for example an
endless screw mechanism, rack and pinion mechanism, or axial and
radial actuators of known type. FIG. 1a shows an embodiment where
the sheath 20 has axial actuators 200 and radial actuators 202.
[0050] The catheter introducer system shown in FIG. 1 includes a
propulsion section 22 that is located near the distal end 4 of
catheter 2. The propulsion section 22 is designed to pull the
portion of catheter 2 near it through a body cavity, so that the
catheter 2 can easily navigate through a cavity like the GI tract.
Since propulsion section 22 is designed to pull from within the
body cavity, catheter 2 can be more flexible than would be possible
if the catheter were pushed from outside of the body cavity,
because catheter 2 does not have to transmit the compression loads
caused by being pushed. As a result, this device reduces the pain
and discomfort felt by the patient, because the device can be made
extremely flexible in bending while also having a large diameter.
Propulsion system 22 includes several sliding gripping pads 24 that
can travel along guides 26 in an axial direction, along the length
of the catheter 2. Gripping pads 24 are located on an outer surface
of catheter 2, and in one embodiment are distributed evenly around
the circumference of the catheter 2. In the preferred embodiment
shown in FIG. 1, gripping pads 24 have suction ports 25 so that
they can attach to the inside surface of the body cavity whenever a
vacuum is applied to the suction port 25.
[0051] In a preferred embodiment according to the invention, each
one of gripping pads 24 can move along guide 26 independently, and
the suction applied to each of suction ports 25 can be turned on or
off independently from that of the other suction ports 25. In a
more preferred embodiment, four gripping pads 24 are provided in
four sliding channels 26, one in each channel, and are spaced about
90.degree. apart from each other around the circumference of
catheter 2. Opposing pairs of gripping pads 24 can be coordinated
to move and apply suction in unison.
[0052] During operation of the propulsion section 22, the gripping
pads 24 move in coordinated manner, gripping, releasing, and
sliding to move the catheter 2 forward and backward. To move
forward, for example, approximately half of the pads 24 in a first
group located at the first position A in sliding channel 26 apply a
vacuum through suction ports 25, so that they become attached to
the tissue of the body cavity. At the same time, a second group of
gripping pads 24 is moved to a second position B in sliding channel
26, without vacuum being applied to their suctions ports 25. In
this phase air may be expelled through the moving suction ports, to
ensure that body tissue does not stick to the moving gripping pads
24. This makes it easier for the gripping pads 24 to slide along
the cavity wall. A saline solution or other fluid may also be
expelled through suction ports 25, to remove any contaminants from
the ports.
[0053] Once the second group of gripping pads 24 reaches position
B, the vacuum is turned on to the ports 25 of those gripping pads,
which attach to the tissue of the body cavity. Vacuum is at the
same time turned off to the first group of gripping pads 24 at
position A. At that point gripping pads 24 at position B are moved
to position A, while maintaining the suction, so that the entire
catheter 2 is pulled forward relative to the body cavity tissue by
a distance substantially equal to the distance between points A and
B of sliding channel 26.
[0054] To move backwards, for example, the same sequence can be
carried out in reverse order, so that the group of gripping pads 24
to which a vacuum is applied are initially moved from point A to
point B of the sliding channel 26, to force the catheter 2 out of
the body cavity.
[0055] Vacuum can be applied to suction ports 25 by turning on and
off a connection to a vacuum source 31. The sliding movement of
gripping pads 24 and suction ports 25 within sliding channel 26 can
be performed in a variety of manners, such as by mechanical
movement of push-pull wires 30, with force from an inflating
bellows, or by activation of linear actuators that respond to
electricity or other changes in their operating environment.
Movement of gripping pads 24 within sliding channel 26 can also be
accomplished in other known manners, such as by using shape memory
actuators, piezoelectric actuators, or other types of actuators
commonly known as artificial muscles.
[0056] The application of a vacuum to the various suction ports 25,
movement of gripping pads 24 within sliding channels 26, and other
control functions can be performed by hand or, in a preferred
embodiment, by a control unit 34 that automatically coordinates the
movement of the individual suctions pads in the sliding channels
and application of suction in response to instructions of the
operator of the catheter system. The operator, for example, could
select movement of the catheter in or out of the cavity, and
control unit 34 could operate propulsion section 22 accordingly.
Control unit 34 could include, for example, a memory containing
sequences of instructions for movement and application of vacuum by
the gripping pads 24, that result in desired movement of the
catheter 2. Control unit 34 could also include an electronic
computer to convert those sequences into commands for servo motors,
valves, and other actuators that affect the operation of gripping
pads 24, and control supply of vacuum from vacuum source 31 via
ducts 33.
[0057] Each of gripping pads 24 could also have more than one
suction port 25 applying vacuum to the body cavity tissue. A
perforated surface could be used instead of an individual port,
having a configuration that will be described in detail below, in
the context of a perforated suction ring.
[0058] In yet another embodiment, different methods for gripping
the inside of the body cavity could be used instead of the suction
pads 24. For example, inflatable balloons could grip the tissue of
the body cavity when inflated, and could be operated in the same
manner as the gripping pads with suction ports.
[0059] The catheter introducer system shown in FIG. 1 includes a
steering section 36 also located adjacent to the distal end 4 of
the catheter 2. In the preferred embodiment the steering section 36
is closer to the opening of the distal end 4 of the catheter than
the propulsion section 22. However, the opposite arrangement can
also be utilized successfully. Steering section 36 allows an
operator to change the direction where distal end 4 is pointed
inside the body cavity. In the preferred embodiment shown in FIG.
2, the steering section 36 comprises a flexible structure, such as
a braid or mesh 37, that defines the outer circumferential surface
of the tube-like catheter 2. Flexible mesh 37 can be collapsed and
can also be extended to several times its collapsed length in a
direction along the length of the catheter 2. In a preferred
embodiment, steering section 36 is formed of a flexible mesh tube
having similar properties to those of an endoscopic or vascular
stent, such as, for example, the Wallstent manufactured by Boston
Scientific Corporation. The flexible mesh tube is designed to
provide sufficient rigidity to maintain a tube-like shape, while
also allowing a change in length of the section.
[0060] The tube formed by flexible mesh 37 can also be bent in a
desired direction by stretching mesh 37 in one circumferential
portion while compressing it on the opposite circumferential
portion of the tube. Steering section 36 can thus be turned in a
selected direction with respect to the center line of the catheter
2.
[0061] The stretching and turning of flexible mesh 37 can be
carried out in a convenient manner by using push-pull cables 38,
shown in FIG. 2. Push-pull cables 38 are sufficiently stiff such
that they can carry a tension as well as a compression load, and
are attached to tip 40 forming the distal end 4 of catheter 2. Tip
40 can preferably be made of aluminum or plastic. In a preferred
example, push-pull wires 38 are made of NITINOL, which is a
super-elastic alloy that resists elastic deformation leading to the
formation of kinks. For disposable catheters, the wires 38 can
alternatively be made of steel, or other materials that tend to
regain their original shape after bending. However, NITINOL wires
are preferred for applications where catheter 2 is used
repeatedly.
[0062] Aluminum tip 40, flexible mesh 37, and push-pull wires 38
are all disposed on the circumference of catheter 2, so that
working channel 10 is left free for introduction of endoscopy
tools. Push-pull cables 38 exit the body cavity and exit from
catheter 2 at the proximal end 6, and can be either manually
controlled or can be controlled by the control unit 34. Control
unit 34 controls the steering section 36 in a similar manner as it
controls the propulsion section 22.
[0063] When push-pull wires 38 are moved together, the length of
the steering section 36 changes, and the tip 40 on distal end 4 of
catheter 2 is pushed further in the body cavity, or is withdrawn
partially from the body cavity. If push-pull wires 38 are acted on
differentially, steering section 36 can be turned in any direction
relative to the length of the catheter 2. Sutures 42 can be used to
attach push-pull wires 38 at discrete locations on the flexible
mesh 37, to control their positioning and to support them, so they
can transmit compression forces without buckling.
[0064] Devices other than sutures 42 can be used to hold push-pull
wires 38 in position around steering section 36. For example, rigid
rings can be fixed at axial locations along the steering section
36, and the push-pull wires 38 can be attached to the rings, or may
be threaded through holes formed in the ring's outer portion.
Alternatively, simple clips or loops can be used to tie push-pull
wires 38 to specific points of mesh 37, so the wires can move only
in the axial direction. Heat shrink, polyurethane, or other type of
low friction flexible cladding can be applied on top of flexible
mesh 37 and wires 38 to facilitate insertion and travel of the
device within the body cavity. The use of a slippery coating for
the catheter makes it easier for the propulsion section 22 to pull
the catheter along the body cavity, and also reduce discomfort to
the patient. The low friction coating can also be used on the
inside of the cladding, to reduce friction with push-pull wires
38.
[0065] In a further embodiment according to the invention, the
steering section 36 can have an outer surface formed by bellows
instead of the flexible mesh 37. The bellows can be inflated or
deflated to extend or contract, in a direction along the length of
the catheter 2. Bellows can be also extended and contracted by
operation of push-pull wires 38, connected to tip 40. In this case,
the bellows are used simply as an outer cover for the mechanism of
the steering section 36, similarly to mesh 37. Holes can be formed
at the crests of the bellows ridges, to guide and keep in place the
push-pull wires 38. The inflatable bellows actuators are further
described in U.S. Pat. Nos. 5,181,452 and 5,317,952 which are
hereby incorporated by reference. The inflation and deflation, or
the extension of various bellows sections can be controlled either
by hand or by a control unit 34. Use of the bellows allows steering
section 36 to either change its length, or to change the direction
where distal end 4 points, in a manner analogous to that described
above.
[0066] As a further alternative to a mesh or bellows, a coil
structure can be used to maintain the push-pull wires 38 in place,
and to give some structural rigidity to the steering section 36.
One or more coils can extend from tip 40 along the length of
steering section 36, and can be connected to wires 38 with any of
the methods described above.
[0067] Sheath 11 defining working channel 10 preferably can be
attached to tip 40 but not to mesh 37. In this manner, mesh 37 can
change length without affecting the shape of the working channel
10.
[0068] FIG. 3 shows a second embodiment of the catheter introducer
system for endoscopy according to the present invention. As shown
in FIG. 3, a tube-like catheter 2 defines a working channel 10 and
has a distal end 4 designed for introduction in the body cavity. As
described above, a resilient sheath 11 can be used to define the
working channel 10. Near the distal end 4 of the catheter 2, there
is a steering/propulsion section 50 that is used both to pull the
rest of the catheter along in the body cavity that is being
explored, and also to direct the distal end 4 of the catheter 2 in
the desired direction.
[0069] Steering/propulsion section 50 comprises a
steering/elongation portion 52 that provides elongation as well as
steering functions for the catheter introducer system 1'. For
example, steering/elongation portion 52 can be formed by a mesh
with push-pull wires similar to the one described in FIG. 2. If the
push-pull wires are extended or withdrawn at the same time,
steering/elongation portion 52 elongates and distal end 4 of the
catheter 2 is extended further or is withdrawn from the body
cavity. If the push-pull wires on one side of steering/elongation
portion 52 are extended, while those generally on the opposite side
of the steering/elongation portion 52 are withdrawn, the
steering/elongation portion 52 will turn towards the withdrawing
wires, thus changing the direction in which distal end 4 is
pointed. A combination of elongation and turning commands can also
be given simultaneously to the steering/elongation portion 52. In a
preferred embodiment, three wires 38 are equally spaced at
120.degree. intervals around the circumference of the
steering/elongation portion 52, and can provide elongation and
steering as described above.
[0070] Preferably, steering/elongation portion 52 is formed of a
flexible mesh tube to which are attached push-pull wires 38. This
configuration retains a large hollow working channel 10 inside the
device because the integrated steering and propulsion mechanism
takes up little wall thickness. Steering/propulsion section 50 also
includes a proximal gripper portion 54 and a distal gripper portion
56 that are-respectively positioned at the proximal and distal ends
of steering/elongation portion 52. Both the proximal and distal
gripper portions 54 and 56 preferably include gripping pads 58 that
have suctions ports 59 that can selectively apply suction to the
surrounding inner surfaces of the body cavity.
[0071] In the preferred embodiment, suction ports 59 are connected
to a vacuum system with a source 31 and ducts 33, so that when the
vacuum is turned on the suction port 59 will attach to the tissue
of the surrounding body cavity. When the vacuum is turned off,
suction port 59 releases its grip on the inner surface of the body
cavity. In a different embodiment of the invention, one or both of
the proximal and distal gripper portions can include other means of
attaching themselves to the inner surface of the body cavity, such
as inflatable balloons, suction arms, or other known devices.
[0072] In a different embodiment, proximal and distal gripper
portions 54, 56 can include a perforated suction ring to apply
vacuum to the surrounding body cavity tissue, instead of discrete
gripping pads 58 with suction ports 59. Several configurations of
perforated suction rings will be described below.
[0073] In another embodiment according to the invention,
steering/elongation portion 52 can include, for example, inflatable
bellows as described above with reference to the steering section
36, instead of push-pull wires and flexible mesh. In yet another
embodiment according to the invention, the push-pull wires can be
replaced by linear actuators 70 embedded within the flexible
structure of catheter 2, as shown in FIG. 4 and as earlier
described.
[0074] Gripper portions 54, 56 move alternatively closer and
farther apart during the progression of catheter 2. The structures
within steering/elongation portion 52 must therefore allow this
movement. For example, as shown in FIG. 19, sheath 11 defining
working channel 10 can be formed by a flexible membrane 150
surrounded by coils 152. This construction results in a sheath 11
that can extend and contract axially while retaining a constant
cross section, and provides a smooth inner surface to the working
channel 10. The tubes that provide suction to distal gripper
portion 56 also have to extend and contract axially. This can be
achieved, for example, using bellows shaped tubes 154, or using
telescoping flexible tubes 156, with seals 158 placed between the
telescoping sections.
[0075] The catheter introducer system 1' shown in FIG. 3 includes
an extremely flexible catheter 2 and is designed to pull itself
along the body cavity where it is introduced, rather than being
pushed as is done with traditional endoscopes. The catheter moves
in an inchworm fashion by coordinated motion and control of the
gripper portions and of the steering/elongation portion.
[0076] For example, to move forward, the proximal gripper portion
54 attaches to the tissue of the body cavity by applying a vacuum
to suction ports 59 of the proximal gripper portion 54. The
steering/elongation portion 52 is then extended, so that the distal
gripper portion 56 is pushed further inside the body cavity.
Suction ports 59 of distal gripper portion 56 then apply a vacuum
to the surrounding tissue so as to attach to the tissue, and the
suction ports 59 of the proximal gripper portion 54 stop applying a
vacuum. In a preferred embodiment, suction ports 59 can also eject
pressurized air to completely release the surrounding tissue. At
that point steering/elongation portion 52 is contracted while the
distal gripper portion 56 continues to attach to the surrounding
tissue, so that the portion of the catheter behind distal gripper
portion 56 is pulled along inside the body cavity by a distance
substantially equal to the contraction distance of
steering/elongation portion 52. The process is then repeated until
the distal end 4 of the catheter 2 reaches the desired position
inside of the body cavity.
[0077] To move backward, the above process is reversed. For
example, the proximal suction gripper 54 attaches to the tissue,
while the distal gripper portion 56 releases the surrounding
tissue. Steering/elongation portion 52 is contracted, so that the
distal end 4 of the catheter 2 is withdrawn from the body cavity.
Proximal gripper portion 54 then releases the tissue, distal
gripper portion 56 attaches to the tissue and the
steering/elongation portion 52 is extended, so that the portion of
the catheter 2 behind distal gripper portion 56 is withdrawn from
the body cavity. The order of attachment and release of grippers 54
and 56 can also be reversed, as long as the contractions and
extensions of steering/elongation portion 52 cause the catheter to
be respectively pulled towards or pushed away from a gripper
portion 54, 56 that is attached to the tissue of the body
cavity.
[0078] The catheter 2 can also simply be pulled out of the body
cavity by the operator. These steps are repeated until the entirety
of catheter 2 is extracted from the body cavity. Throughout the
operation, steering is achieved by bending the steering/elongating
portion 52 either while the insertion or extraction movement is
carried out, or separately while the catheter 2 remains in
position. As shown in FIG. 1, a control unit 34 can be used to
coordinate the operation of steering/propulsion section 50, such as
bending and elongation of steering/elongation portion 52, and
application of suction.
[0079] The second embodiment according to the invention shown in
FIG. 3 also provides a large working channel 10 through which
various endoscopy tools can be inserted and positioned easily in
the desired portion of the body cavity. A tool ideally suited for
this device is a suction polypectomy device to remove polyps from
the intestine. The effectiveness of such device is currently
limited by the small working channel of existing endoscopes, but
this drawback is resolved by using the catheter introducer system
according to the invention.
[0080] Several variations can be made to the design of the gripping
pads 58 and 24 described above in conjunction to the embodiments of
the invention shown in FIGS. 1 and 3. These variations are designed
to maximize the traction or gripping force exerted by the gripping
pads on the surrounding tissue of the body cavity.
[0081] In one embodiment shown in FIG. 5, the gripping pads 58 can
be replaced by a perforated suction ring 100, having an outer
surface 104 with a plurality of holes 102. Independently
controllable sources of suction and compressed air are provided to
gripper portions 54', 56', which can be moved close together or
apart along the steering/elongation portion 52, as described above
with reference to FIG. 3. In this example, suction is applied to
the surrounding tissue through holes 102. Holes 102 are designed to
distribute the suction over a large area of tissue, so that the
traction force generated is increased. A suction ring 100 with
multiple holes 102 also reduces the chances that holes 102 will be
clogged by the tissue, or other debris or contaminants. To further
prevent clogging, provisions can be made to eject pressurized air
or a liquid from holes 102, to force any contaminants out of holes
102.
[0082] Suction ring 100 also defines a buffer area, or plenum 101
disposed between the perforated outer surface 104 and the suction
connection duct 33, as shown in FIG. 6. Plenum 101 is used to
separate the suction duct 33 from the holes 102 on suction ring
100, so that suction is distributed to a larger area of tissue, and
clogging of the vacuum supply is prevented. Plenum 101 can be, for
example, an enclosed toroidal volume between surface 104 and the
center of suction ring 100. Plenum 101 may also be divided in
non-communicating portions, each connected to a different section
of suction ring 100.
[0083] An additional perforated screen can be placed under the
surface of suction ring 100. This additional screen has holes
smaller than holes 102, and acts as a filter to further prevent
clogging of duct 33. Holes 102 can have a size optimized to
maximize suction, while the holes of the additional screen are
optimized to stop contaminants.
[0084] The push-pull wires used to control turning and elongation
of the catheter travel across at least one of the suction rings 100
before reaching the distal portion 4 of catheter 2. Thus the wires
must be insulated from the suction source, to prevent vacuum leaks.
For example, as shown in FIG. 5, the wires 38 could pass through a
passage 120 drilled through suction ring 100, sealed from the
portions connected to the suction. Alternatively, wires 38 could
pass through a sealed tube crossing plenum 101.
[0085] In different embodiments, holes 102 do not have to be
uniformly distributed around the outer surface 104 of perforated
suction ring 100. For example, as illustrated in FIG. 7, the holes
can be grouped in perforated sectors 106 separated by sectors 108
that are not perforated. Sectors 106 may be connected to separate
sources of suction, so that if one of the sectors becomes detached
from the tissue, the remaining sectors will not be adversely
affected, and will continue to apply full suction to the portions
of tissue to which they are attached. In one example, holes 102 can
have a diameter of approximately 0.04 in., and sectors 106 can
extend for approximately 85 degrees of arc, and can be equally
spaced around the circumference of suction ring 100.
[0086] As shown in FIG. 8, holes 102' having a different size can
be utilized on suction ring 100. For example, holes of a diameter
of about 0.02 in. can be formed. The size of the holes is optimized
to obtain the best suction without excessive clogging. Smaller and
more numerous holes tend to grip better the tissue, but clog more
easily. Fewer larger holes clog less, but also tend to provide less
traction on the tissue. Different sizes of holes can be used in all
the configurations of suction ring 100 described here.
[0087] In a different embodiment, portions of suction ring 100
having holes 102 can be recessed with respect to the rest of the
outer surface 104 of suction ring 100. For example, as shown in
FIG. 9, recessed portions 121 have a plurality of holes 102 to
apply suction to the surrounding tissue. The remaining sectors 108
are not perforated. The purpose of this design is to obtain a
configuration of the suction holes 102 that increases traction by
drawing portions of the body tissue in recessed portions 121. As
the previous configurations, the recessed pattern of FIG. 9 could
be made with different size holes, and could encompass different
portions of suction ring 100.
[0088] FIG. 10 shows a configuration of suction ring 100 that is
especially advantageous when the body cavity is inflated with a
gas, to facilitate visual inspection and passage of medical
instruments. When a gas is forced in the cavity, such as the colon,
it passes around the catheter, and tends to detach portions of the
outer surface of suction ring 100 from the surrounding tissue. If a
portion of perforated suction ring 100 is detached, the rest of
suction ring 100 also is likely to become detached from the tissue,
especially if outer surface 104 is uniformly perforated. Axial
ridges 122 assist in the formation of folds in the tissue
surrounding the suction ring 100. The gas forced past suction ring
100 can thus flow in a passage formed by the tissue folds, so that
sectors 106 remain attached and keep the suction ring 100 in
place.
[0089] FIG. 20 shows another design that allows passage of gases
forced through the cavity. Suction ring 100 includes perforated
sectors 106 separated by grooves 160. Grooves 160 provide a channel
for flowing gases, while perforated sectors 106 remain attached to
the surrounding tissue.
[0090] In certain applications, it may be desirable to apply
suction to only a portion of the circumference of suction ring 100.
FIG. 11 shows one example of such application, where a perforated
sector 106 extends over an arc of approximately 85 deg., and the
rest of suction ring 100 is not perforated. As described above, the
pattern and size of holes 102 can be optimized as desired. In
addition, various features also described above can be included in
this design, such as axial ridges 122 shown in FIG. 12, and a
recessed construction of perforated sector 106, shown in FIG. 13.
As before, the purpose of these features is to maximize traction
and prevent separation of the entire suction ring 100 from the body
cavity tissue.
[0091] FIG. 14 shows a further embodiment of the suction ring 100,
where the perforated sector 106 is recessed, and is further
surrounded by peripheral ridges 126. Peripheral ridges 126 are
disposed around the recess 124, and protrude above the outer
surface 104 of suction ring 100. Peripheral ridges 126 act as a
seal that separates the portion of cavity tissue on which
perforated sector 106 applies a suction, and the rest of the cavity
tissue. In this manner, fluids can flow through the body cavity
while the catheter 2 is inserted in the body cavity. The flow can
pass between the non perforated sectors 108 of suction ring 100 and
the body tissue, while perforated sector 106 together with
peripheral ridges 126 maintains a suction against the tissue, and
is thus anchored in place.
[0092] As shown in FIG. 15, suction can be applied to the tissue by
slots 132, rather than by round holes 102 described above. Slots
132 can be used with any of the configurations described, and can
be disposed perpendicular to the relative motion of catheter 2, as
shown in FIG. 15b.
[0093] The several configurations of suction ring 100 are
especially well suited for use in conjunction with the proximal and
distal gripper portions 54,56 shown in FIG. 3. However, the same
configurations can also be successfully utilized to maximize the
traction generated by gripping pads 24 shown in FIG. 1.
[0094] The traction force that can be generated by the propulsion
sections of catheter 2 can be increased by increasing the folds and
undulations of the cavity tissue in contact with the suction ring
100, thus generating an interference between the tissue of the
inner surface of the body cavity and fixed protrusions of the
gripping pads 24, 58. For example, suction can be used to draw some
tissue in holes, slots or between protrusions formed on suction
ring 100. Folds in the tissue then interact with the edges of these
structures to generate a force opposing the relative motion between
the tissue and suction ring 100 greater than would be possible if
the two were simply sliding past each other.
[0095] FIG. 16 shows one possible exemplary embodiment utilizing
this principle. Tissue 200 of the inner surface of a body cavity is
partially drawn inside hole 102 formed in perforated sector 106 of
suction ring 100. As suction ring 100 mounted on catheter 2 is
moved in a relative direction A, a force F.sub.A resisting the
relative motion is applied by the portion of tissue 200 that is
drawn by suction inside hole 102. To further increase this traction
force, means can be employed to urge the portion of tissue 200
drawn within hole 102 against the perimeter of hole 102. For
example, inflatable parts 150 could be inflated, as shown by dashed
line 152, to hold tissue 200.
[0096] In a different embodiment shown in FIG. 16b, after being
drawn inside hole 102, tissue 200 can be trapped between a sleeve
153 and the perimeter of hole 102. For example, sleeve 153 can be
concentric with the suction ring 100, and be rotatable or
translatable just inside of outer surface 104.
[0097] A different exemplary embodiment of a design to increase
traction forces is shown in FIGS. 17 and 18. In this case,
protrusions extend from the surface of suction ring 100 to interact
with the tissue that is drawn between the protrusions by suction.
As shown in FIG. 17, the protrusions can be, for example, ridges
136 disposed in a substantially circumferential direction around
suction ring 100. Suction holes 102 can be disposed between the
ridges 136, or even on the raised sides of the ridges 136. Instead
of ridges, suction ring 100 can have a "soap dish" surface
construction, where a plurality of studs 138 extend from the outer
surface, and are interspersed with suction holes 102. This
embodiment is shown in FIG. 18. To maximize the resistance to
relative movement between the catheter and the tissue, the studs
can be staggered in the direction of relative movement. The designs
shown in FIGS. 17 and 18 take advantage of the same mechanism
described with reference to FIG. 16.
[0098] The force exerted by gripper portions 54, 56 can also be
varied by changing the axial length of suction ring 100, and the
number of rows of holes 102. For example, FIG. 21a shows a suction
ring 100' having two additional rows of holes 102, in the axial
direction of the catheter. FIG. 21b shows the same suction ring
100' used in a gripper portion 54, 56, to generate a greater
force.
[0099] An example of how the catheter introducer system according
to the invention can be used will now be described with reference
to FIGS. 1 through 3. A common procedure in endoscopy is the
examination of the colon and removal of polyps present in the
colon. A vision light tool (VLT) is inserted into the steering
catheter 2 and is secured to the end of the catheter 2. Catheter 2
is then inserted into the rectum using a rigid sheath 20. The
catheter 2 is then driven through the intestine towards the cecum
while being guided and controlled by a control unit 34. In one
embodiment according to the invention, control unit 34 includes a
monitor through which the operator can view what is being
transmitted by the VLT, so that he can drive the catheter forward
or backwards while simultaneously steering it. During tests, the
propulsion section was able to resist a pulling force of
approximately 2.5 lbs. while remaining attached in position in a
colon by suction.
[0100] After reaching the cecum, the device is then slowly pulled
back from the cecum to the rectum, as the interior of the intestine
is inspected. When a polyp is sighted, a suction polypectomy device
is inserted into the catheter until it protrudes from the distal
end 4 of catheter 2, and is seen on the monitor by the operator.
The suction polypectomy tool is steered to the polyp, and the polyp
is excised and withdrawn by vacuum through the suction channel of
the polypectomy tool. Additional tools can be introduced and
brought into position at the site of interest rapidly and easily
through working channel 10, because catheter 2 maintains access to
the operation site while various tools are withdrawn and inserted
back into the catheter.
[0101] In a preferred embodiment according to the invention, the
various diagnostic and therapeutic tools used in endoscopy are
positioned accurately with respect to the body cavity by moving the
distal end 4 of the catheter 2 with the steering section 36, or
with the steering/propulsion section 50. In a different embodiment,
still within the scope of the invention, the endoscopic tools can
be positioned accurately by using a separate positioning system,
which could include push-pull wires 72 similar to those shown in
FIG. 2, or a system including inflatable bellows, linear actuators,
or a combination of these devices. Also in a preferred embodiment
according to the invention, many components of the catheter
introducer system are disposable, thus assuring a high degree of
sterility to the device. For example, the flexible tube of catheter
2 can be disposable, as well as various portions of the endoscope
tools 8 used within working channel 10.
[0102] As indicated, the catheter introducer system of the present
invention could be used to navigate within body cavities other than
the GI tract. For example, air passages or blood vessels could be
explored using this system. For blood vessels, it would be
necessary to reduce the size of the apparatus, and preferably to
only use the steering section, to avoid interference with blood
flow through the vessel. For example, an outer diameter of the
device would have to be less than about 2 mm.
[0103] It will be apparent to those skilled in the art that various
modifications and variations can be made in the structure and the
methodology of the present invention, without departing from the
spirit or scope of the invention. Thus, it is intended that the
present invention cover the modifications and variations of this
invention provided they come within the scope of the appended
claims and their equivalents.
* * * * *