U.S. patent application number 10/458060 was filed with the patent office on 2004-07-15 for endoluminal tool deployment system.
This patent application is currently assigned to USGI Medical Corp.. Invention is credited to Brenneman, Rodney, Chen, Eugene, Ewers, Richard C., Saadat, Vahid, Wiltshire, Brent R..
Application Number | 20040138529 10/458060 |
Document ID | / |
Family ID | 32712216 |
Filed Date | 2004-07-15 |
United States Patent
Application |
20040138529 |
Kind Code |
A1 |
Wiltshire, Brent R. ; et
al. |
July 15, 2004 |
Endoluminal tool deployment system
Abstract
Systems, devices and methods are provided for endoscopic
procedures involving tissue manipulations beyond the capabilities
of traditional endoscopic instruments. Embodiments of the systems
include an elongated main body having a scope therethrough. Some
embodiments of the systems include an elongated main body which is
rigidizable and/or torque transmitting to improve manipulation
through passageways in the body.
Inventors: |
Wiltshire, Brent R.;
(Carlsbad, CA) ; Ewers, Richard C.; (Fullerton,
CA) ; Brenneman, Rodney; (San Juan Capistrano,
CA) ; Chen, Eugene; (Carlsbad, CA) ; Saadat,
Vahid; (Saratoga, CA) |
Correspondence
Address: |
TOWNSEND AND TOWNSEND AND CREW, LLP
TWO EMBARCADERO CENTER
EIGHTH FLOOR
SAN FRANCISCO
CA
94111-3834
US
|
Assignee: |
USGI Medical Corp.
San Clemente
CA
|
Family ID: |
32712216 |
Appl. No.: |
10/458060 |
Filed: |
June 9, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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10458060 |
Jun 9, 2003 |
|
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10346709 |
Jan 15, 2003 |
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Current U.S.
Class: |
600/144 |
Current CPC
Class: |
A61B 2017/00349
20130101; A61B 1/0055 20130101; A61B 1/0057 20130101; A61B 1/313
20130101; A61B 2017/2906 20130101; A61M 25/0147 20130101; A61M
25/0105 20130101; A61M 2025/0096 20130101; A61B 2017/3445 20130101;
A61B 2017/00323 20130101; A61B 2017/003 20130101; A61B 1/018
20130101; A61M 25/0043 20130101; A61B 2090/306 20160201; A61B
17/00234 20130101; A61B 2090/508 20160201 |
Class at
Publication: |
600/144 |
International
Class: |
A61B 001/00 |
Claims
What is claimed is:
1. An endoluminal system comprising: an elongated main body having
a proximal end, a distal end sized for passage through a body
lumen, and at least one lumen extending between the proximal and
distal ends; a torque transmitting feature which provides torque
transmission between the proximal and distal ends while the main
body is unlocked and able to form a desired configuration; and a
locking mechanism which locks the main body in the desired
configuration.
2. The endoluminal system of claim 1, further comprising a
visualizing element.
3. The endoluminal system of claim 2, wherein the visualizing
element is integral with the main body.
4. The endoluminal system of claim 2, wherein the at least one
lumen comprises a visualizing lumen and the visualizing element is
configured for passage through the visualizing lumen.
5. The endoluminal system of claim 4, wherein the visualizing
element comprises an endoscope.
6. The endoluminal system of claim 1, wherein the at least one
lumen comprises an arm guide lumen.
7. The endoluminal system of claim 6, further comprising at least
one tool arm being adapted to extend through the arm guide
lumen.
8. The endoluminal system of claim 1, further comprising a steering
mechanism which steers the main body to the desired configuration
while the main body is unlocked.
9. The endoluminal system of claim 1, wherein at least a portion of
the elongated main body comprises a plurality of adjacent
links.
10. The endoluminal system of claim 9, wherein the plurality of
adjacent links comprises at least a first link and an adjacent
second link, the torque transmitting feature comprising a tooth
from the first link slidably engageable with a groove in the
adjacent second link.
11. The endoluminal system of claim 9, wherein the plurality of
adjacent links comprises at least a first link and an adjacent
second link, the torque transmitting feature comprising a pin from
the first link slidably engageable with a slot in the adjacent
second link.
12. The endoluminal system of claim 9, wherein the torque
transmitting feature comprises a fluted shape of the at least one
lumen.
13. The endoluminal system of claim 9, wherein the torque
transmitting feature comprises an oval shape of the plurality of
adjacent links.
14. The endoluminal system of claim 13, wherein the torque
transmitting feature comprises a plurality of rods extending
through the adjacent links.
15. The endoluminal system of claim 14, wherein the plurality of
rods comprises approximately 8 to 64 rods.
16. The endoluminal system of claim 9, wherein the steering
mechanism comprises at least one pullwire extending through the
plurality of adjacent links.
17. The endoluminal system of claim 1, wherein the torque
transmitting feature comprises a torque transmitting covering over
the main body extending between the proximal and distal ends.
18. The endoluminal system of claim 17, wherein the torque
transmitting covering comprises a sheath having reinforcements.
19. An endoluminal device comprising: an elongated main body having
a proximal end, a distal end, and at least one lumen extending
between the proximal and distal ends, at least a portion of the
elongated main body comprising a plurality of adjacent engageable
links; and a torque transmitting feature which provides torque
transmission by preventing disengagement of the adjacent links
while the main body is unlocked and able to form a desired
configuration.
20. The endoluminal device of claim 19, wherein the plurality of
adjacent engageable links comprises at least a first link and an
adjacent second link, the torque transmitting feature comprising at
least one pin from the first link slidably engageable with at least
one slot in the adjacent second link.
21. The endoluminal device of claim 20, wherein the at least one
pin comprises a pair of pins, each pin extending outwardly from an
outer surface of the first link in a diametrically opposite
position from the other pin.
22. The endoluminal device of claim 21, wherein the at least one
slot comprises a pair of slots, each slot configured to accept one
or the pair of pins passing therethrough.
23. The endoluminal device of claim 22, wherein the first link
comprises a first domed ring having the outer surface and the
adjacent second link comprises a second domed ring having an inner
surface, the outer surface of the first domed ring mateable with
the inner surface of the second domed ring along a longitudinal
axis, and the rings rotateable away from the longitudinal axis.
24. The endoluminal device of claim 22, wherein each slot comprises
an elongate opening between a first slot end and a second slot end,
the slot ends substantially aligned with the longitudinal axis to
allow sliding of the pins through the slots during rotation of the
rings away from the longitudinal axis.
25. The endoluminal device of claim 19, wherein the torque
transmitting feature comprises a torque transmitting covering over
the plurality of adjacent engageable links to prevent disengagement
of the adjacent links.
26. The endoluminal device of claim 19, further comprising a
locking mechanism which locks the links in the desired
configuration.
27. An endoluminal device comprising: an elongated main body having
a proximal end, a distal end, and at least one lumen extending
between the proximal and distal ends, at least a portion of the
elongated main body comprising a at least a first link and an
adjacent second link which are rotateable relative to each other
when unlocked; a torque transmitting feature comprising at least
one protrusion from the first link slidably engageable with at
least one groove in the adjacent second link, the torque
transmitting feature providing torque transmission through the
portion of the main body while the links are rotateable; and a
locking mechanism which locks the links upon actuation by
preventing rotation of the links relative to each other.
28. The endoluminal device of claim 27, wherein the at least one
protrusion comprises a pair of protrusions, each protrusion
extending outwardly from an outer surface of the first link in a
diametrically opposite position from the other protrusion.
29. The endoluminal device of claim 28, wherein the at least one
groove comprises a pair of grooves, each groove configured to
accept one or the pair of protrusions passing therein.
30. The endoluminal device of claim 29, wherein the first link
comprises a first domed ring having the outer surface and the
adjacent second link comprises a second domed ring having an inner
surface, the outer surface of the first domed ring mateable with
the inner surface of the second domed ring along a longitudinal
axis, and the rings rotateable away from the longitudinal axis.
31. The endoluminal device of claim 30, wherein each groove
comprises a first groove end and a second groove end, the groove
ends substantially aligned with the longitudinal axis to allow
sliding of the protrusions along the grooves during rotation of the
rings away from the longitudinal axis.
32. An endoluminal device comprising: an elongated main body having
a proximal end, a distal end, and at least one lumen extending
between the proximal and distal ends, at least a portion of the
elongated main body comprising a plurality of adjacent links which
are rotateable relative to each other when unlocked; a torque
transmitting covering over the plurality of adjacent links
providing torque transmission therethrough while the links are
rotateable; and a locking mechanism which locks the links upon
actuation by preventing rotation of the links relative to each
other.
33. The endoluminal device of claim 32, wherein the torque
transmitting covering comprises a snuggly fit sheath.
34. The endoluminal device of claim 33, wherein the sheath includes
reinforcements.
35. The endoluminal device of claim 34, wherein the reinforcements
comprises nylon, polyurethane, polyethylene, Teflon, metal, or
polymer.
36. The endoluminal device of claim 34, wherein the reinforcements
have a braided or woven arrangement.
37. The endoluminal device of claim 34, wherein the reinforcements
has been coated with a polymer.
38. The endoluminal device of claim 32, wherein the torque
transmitting covering comprises a polymer coating.
39. An endoluminal device comprising: an elongated main body having
a proximal end, a distal end, and at least one lumen extending
between the proximal and distal ends, at least a portion of the
elongated main body comprising at least a first link and an
adjacent second link which are rotateable relative to each other
when unlocked, one of the at least one lumen extending through the
links having at least one partition; an elongated shaft passing
through one of the at least one lumen in a manner to transmit
torque by contacting the least one partition; and a locking
mechanism which locks the links upon actuation by preventing
rotation of the links relative to each other.
40. The endoluminal device of claim 39, wherein the at least one
partition comprises an inward protrusion.
41. The endoluminal device of claim 40, wherein the at least one
lumen extending through the links has a fluted shape forming the
inward protrusions.
42. The endoluminal device of claim 40, wherein the at least one
partition comprises at least one divider spanning across the one of
the at least one lumen.
43. The endoluminal device of claim 39, wherein the at least one
lumen includes at least one steering lumen through which a pullwire
passes for use in steering the elongated main body.
44. The endoluminal device of claim 43, wherein the at least one
steering lumen comprises a plurality of steering lumens around the
one of the at least one lumens.
45. A method of accessing comprising: providing an elongated main
body having a proximal end, a distal end, a visualizing element and
a locking mechanism, wherein the main body is capable of forming a
desired configuration in an unlocked state and holding the desired
configuration in a locked state; introducing the main body through
a body passageway in the unlocked state forming the desired
configuration so that the distal end reaches a target location;
actuating the locking mechanism to hold the main body in the
desired configuration; and viewing the target location with the use
of the visualizing element.
46. A method as in claim 45, wherein introducing the main body
comprises allowing the main body to assume a shape of the body
passageway in the unlocked state forming the desired
configuration.
47. A method as in claim 46, wherein the main body comprises a
plurality of adjacent links and wherein actuating the locking
mechanism comprises holding the links in a fixed relation to each
other.
48. A method as in claim 47, wherein the plurality of adjacent
links comprises a plurality of nestable elements and wherein
holding the links comprises wedging the links together to hold them
by friction.
49. A method as in claim 45, wherein introducing the main body
comprises steering the main body through the body passageway in the
unlocked state forming the desired configuration.
50. A method as in claim 49, wherein the main body comprises a
plurality of adjacent links and wherein actuating the locking
mechanism comprises holding the links in a fixed relation to each
other.
51. A method as in claim 50, wherein the plurality of adjacent
links comprises a plurality of nestable elements and wherein
holding the links comprises wedging the links together to hold them
by friction.
52. A method as in claim 45, wherein the main body includes at
least one lumen extending between the proximal and distal ends, and
further comprising introducing an instrument through the at least
one lumen.
53. A method as in claim 52, wherein the instrument comprises a
tool arm.
54. A method as in claim 45, wherein the elongated main body
further includes a visualizing lumen and the visualizing element
comprises an endoscope, the method further comprising positioning
the endoscope within the visualizing lumen.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of, and claims
the benefit of priority from co-pending U.S. patent application
Ser. No. 10/346,709, filed Jan. 15, 2003, and also claims the
benefit of prior Provisional Application No. 60/______, filed on
May 19, 2003, the full disclosures of which are hereby incorporated
herein by reference.
STATEMENT AS TO RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSORED
RESEARCH OR DEVELOPMENT
[0002] NOT APPLICABLE
REFERENCE TO A "SEQUENCE LISTING," A TABLE, OR A COMPUTER PROGRAM
LISTING APPENDIX SUBMITTED ON A COMPACT DISK.
[0003] NOT APPLICABLE
BACKGROUND OF THE INVENTION
[0004] The present invention relates generally to medical devices,
systems and methods. More particularly, the present invention
relates to devices, systems and methods for use in endoscopic or
laparoscopic procedures.
[0005] Endoscopy is a form of minimally invasive procedure wherein
the interior of the body is accessed and visualized through an
orifice in the body, such as the esophagus or rectum. Such access
allows a surgeon or physician to view and/or treat internal
portions of the orifice or internal tissues or organs which are
accessible through the orifice. These procedures may be for
diagnostic purposes, such as visual inspection or the removal of a
tissue sample for biopsy, or the procedure may be used for
treatment purposes, such as the removal of a polyp or tumor or the
restructuring of tissue. While these procedures can be done using
regular open surgery, endoscopy usually involves less pain, less
risk, less scarring, and faster recovery of the patient.
[0006] Endoscopy is typically performed with the use of an
endoscope, a small circular tube containing optical components.
Traditional endoscopes comprise a small diameter "snake-like"
insertion tube having a distal end which is inserted into the
orifice to the desired internal location. Fiber optics extend
through the insertion tube and terminate at the distal end to allow
axial viewing from the distal end. Images of the internal location
near the distal end of the endoscope are transmitted to a video
monitor for the physician to view. A control handle allows the
endoscopist to control the direction of the scope and in some
cases, permits the actuation of air, water and suction utilities
that may be required for the endoscopy procedure.
[0007] Since endoscopes may be used to perform a treatment at an
internal location, some endoscopes are equipped with a lumen
through which a surgical instrument or tool may be passed.
Generally, the lumen extends through the length of the insertion
tube to the distal end so that the end effector of the inserted
instrument protrudes from the distal end in the axial direction.
Thus, the instrument is directed in parallel to the fiber optics so
that the end effector is positioned along the line of view.
[0008] Such endoscopes have a number of constraints which limit
their usefulness in performing diagnostic and surgical procedures.
To begin, surgical instruments and tools are inserted axially
through a working lumen in the endoscope. And, most of these
endoscopes only allow axial and rotational movement of the tool
beyond the distal end. This helps to maintain positioning of the
tool within the field of view of the endoscope which is also
directed axially. However, this limits the variety and complexity
of procedures that may be performed. For example, procedures which
involve tissue approximation pose great difficulty since only one
portion of tissue may be grasped at a time and lateral, rather than
axial, movement may be required. Although steering of an axially
inserted tool may be possible near the distal end, such steering
typically positions the end effector of the tool out of the field
of view of the axially directed scope.
[0009] A similar minimally invasive procedure which overcomes some
of these constraints is laparoscopy. In laparoscopy, the interior
of the body is accessed and visualized through a small incision.
When accessing the abdomen, the incision is usually made in the
navel. Laparoscopy was initially used by gynecologists to diagnose
and treat conditions relating to the female reproductive organs:
uterus, fallopian tubes, and ovaries. It is now used for a wider
range of procedures, including operations that in the past required
open surgery, such as removal of the appendix (appendectomy) and
gallbladder removal (cholecystectomy). Laparoscopy is performed
with a device which allows the surgeon or physician to view and/or
treat internal tissues or organs which are accessible through the
incision. This device is the same or similar to an endoscope,
sometimes referred to as a laparoscope. The device comprises a
small diameter insertion tube having a distal end which is inserted
into the incision to the desired internal location. Fiber optics
extend through the insertion tube and terminate at the distal end
to allow axial viewing from the distal end. Images of the internal
location near the distal end are transmitted to a video monitor for
the physician to view. Sometimes, access through an incision
creates a shorter, straighter and more direct access path than
through an orifice. Therefore, some laparoscopes may have a shorter
and stiffer insertion tube than some endoscopes.
[0010] Although laparoscopes suffer from many of the same
limitations as endoscopes, laparoscopy allows additional surgical
instruments and tools to be inserted through separate incisions to
perform procedures. Proper location of the incisions can allow
instruments to be positioned in various directions. Therefore,
movement and viewing is not limited to the axis of the laparoscope
and simultaneous viewing of the tissues and the instruments may be
more readily achieved during the procedure. However, these
additional benefits are achieved at the cost of increased
invasiveness. Access paths must be created for the instruments with
the use of trocars requiring general anesthesia, risk of
complications and infection, and increased overall recovery time
for the access paths to heal. In addition, access may be difficult
or contraindicated in some patients, particularly in the morbidly
obese.
[0011] Thus, it would be desired to provide an improved methods,
devices and systems to perform minimally invasive procedures.
Particularly, methods, devices and systems which would provide the
benefits of endoscopy, such as lower invasiveness and access to
deeply internal locations, with the benefits of laparoscopy, such
as the use of multiple instruments with movement and viewing along
various axes. The devices and systems would be reliable, convenient
and easy to use with improved outcomes for patients due to
reduction in invasiveness and therefore risk, cost and recovery
time. At least some of these objectives will be met by the
invention described hereinafter.
[0012] In addition, it would be desired to provide improved
methods, devices and systems which would provide improve passage
and manipulation through endovascular passageways. Typical
endoscopes have a length in the range of 130 to 190 cm and may be
used to traverse a variety of tortuous paths within the body. For
example, endoscopes may be used to access the lower
gastrointestinal tract from entry through the anus, sometimes
reaching as far as the cecum at the distal end of the colon. The
upper gastrointestinal tract may be accessed through the esophagus
to the stomach and the upper regions of the small intestine.
Achieving access to any of these regions, particularly through the
colon, involves tedious manipulation of the endoscope. Much of this
manipulation involves torqueing of the endoscope. However, once a
substantial length of the endoscope has passed into the body,
torqueing becomes increasingly difficult. In addition, accessing
such regions usually takes place through minimally supported
lumens, such as the colon, which do not provide resistive strength
or through open cavities, such as the stomach, which do not provide
particular pathways for the endoscope. This also limits the use of
endoscopic access to desired treatment locations.
[0013] Thus, it would be desired to provide improved methods,
devices and systems to access desired treatment locations.
Particularly, methods, devices and systems which would improve the
ability to access desired treatment locations minimally invasively,
particularly endoscopically or laparoscopically. The devices and
systems would be reliable, convenient and easy to use with improved
outcomes for patients due to reduction in invasiveness and
therefore risk, cost and recovery time. At least some of these
objectives will be met by the invention described hereinafter.
BRIEF SUMMARY OF THE INVENTION
[0014] The present invention provides systems, devices and methods
for endoscopic procedures involving tissue manipulations beyond the
capabilities of traditional endoscopic instruments. Some
embodiments of the systems include an elongated main body which is
rigidizable and/or torque transmitting to improve manipulation
through passageways in the body. And, some embodiments of the
systems include an elongated main body having a scope therethrough
and at least one steerable tool arm which extends from the distal
end of the main body. In these embodiments, the system typically
includes two tool arms, each arm steerable to form a curve
laterally outward which then bends laterally inward so that the
arms form a an angular or boomerang shape. In addition, end
effectors extend from the distal ends of each arm for use in
manipulation of tissue. The angular shape brings the end effectors
together in view of the scope for cooperative movements which are
continuously visible by the surgeon through the scope. In addition,
the tool arms may be steerable in any additional direction and may
be rotateable to allow grasping, pulling, tugging, elevation and
more complex manipulation of tissue. Thus, the systems and devices
of the present invention provide many of the capabilities of open
surgery or laparoscopic surgery with an endoscopic approach. In
addition, the systems and devices of the present invention provide
improvements in manipulation for accessing desired treatment
locations.
[0015] In a first aspect of the present invention, the tool arm(s)
comprise a shaft having a proximal end and a deflectable or
steerable distal end. In some embodiments, the steerable distal end
will be laterally stabilized so that the distal end may be steered,
i.e. bent or manipulated, within a plane but will resist deflection
outside of the plane during use. The steering plane will generally
be parallel to a central axis of the scope but may be rotated by
rotation of the tool arm. In this way, the arm(s) will maintain
stable positioning within the field of view of the scope and will
resist accidental deflection outside of the field. It may be
appreciated that the tool arm may also be translated axially within
the stabilized plane while maintaining viewing within the
field.
[0016] A preferred structure for achieving lateral stability
comprises a plurality of adjacent links. Usually, the links are
pivotally attached by hinged structures. In some embodiments, the
hinged structures comprise pivot pins which are disposed parallel
to one another and generally transverse to the stabilized plane in
which the arm may be steered. In other embodiments, the hinged
structures comprise male and female bearing surfaces which define
axes, wherein the axes are disposed in parallel to limit deflection
of the distal section to within the plane. A variety of other
structures are also available to provide lateral stability, such as
deployment frames, various shaped linkages connected by
reinforcements or pullwires, and slotted tubes, to name a few.
[0017] Typically, the distal end includes at least two steerable
sections, wherein a distal-most steerable section includes a tip
section which curves in a first direction and wherein an
intermediate steerable section includes a base which curves in the
opposite direction, where both curves are in the stabilized plane.
In some embodiments, the tip section curve has a radius which is
greater than that of the curve of the base. To achieved such
curvatures, the adjacent links may be shaped to allow substantially
continuous deflection. Or, the adjacent links may be shaped so that
the steerable distal end is deflectable to form a predetermined
curvature wherein the arm is then restricted from further
deflection.
[0018] Means for selectively deflecting the distal section of the
tool arm(s) often comprise at least one pullwire or one pushwire.
Such pull or pushwires may be present in any quantity and
arrangement. The means for selectively deflecting the distal
section can further include at least one spring which is configured
to straighten the distal section in opposition to the pullwire or
pushwire.
[0019] In some embodiments, the tool arm includes an end effector
disposed at its distal end. A wide variety of end effectors may be
used depending on the procedure or tissue manipulations which are
desired. For example, end effectors may include but are not limited
to knives, needles, sutures, staplers, fasteners, clippers,
electrosurgical or hemostatic cutters and coagulators, laser
welders, cryosurgery instruments, secondary scopes, forceps, lasers
hooks, tongs, graspers, retractors, probes, clamps, scissors,
tissue approximation devices and suction applicators.
Alternatively, the tool arm may include a tool deployment lumen
through which a tool having an end effector may be passed. In these
embodiments, the tool arm may include a steering cuff arranged for
passage of the tool therethrough so that manipulation of the tool
within the steering cuff steers the distal end of the tool arm.
Thus, in either case, manipulation of the end effector and the tool
arm may be interconnected.
[0020] In another aspect of the present invention, the elongated
main body has a distal end, a proximal end, and an arm guide lumen
extending through at least a distal section of the elongated main
body. In preferred embodiments, the elongated main body has a
viewing or scope lumen extending therethrough and terminating in
the distal tip. It may be appreciated that the scope lumen may be
used for passage of any viewing element or device or the scope
lumen may comprise a viewing element or device fixed or integrated
within the main body. Herein, it will be assumed that the term
"scope lumen" will be used to refer to either of these
embodiments.
[0021] The arm guide lumens and the viewing scope lumen may be
arranged in any suitable fashion within the main body. For example,
when the elongated main body has a second arm guide lumen, the
distal terminations of the two arm guide lumens and the one viewing
scope lumen may be arranged in a generally triangular pattern on
the distal tip of the main body. Alternatively, the lumens may be
aligned, wherein the viewing scope lumen is disposed between the
arm guide lumens.
[0022] Typically, at least the distal section of the elongated main
body is steerable. In some embodiments, the elongated main body
comprises a first section and a second section, the first section
disposed proximally of the second section, and the first and second
sections are independently lockable. Thus, the first section may be
lockable while the second section remains steerable. Such steering
may be achieved with means for selectively deflecting the second
section within at least a single plane. This may include
retroflexion wherein the distal end of the main body is directed
toward the proximal end. In some embodiments, the distal section of
the elongated main body comprises a plurality of adjacent links to
allow for such steering.
[0023] Typically, at least the distal section of the elongated main
body has a generally cylindrical exterior wherein the arm guide
lumen does not extend out of the cylindrical exterior. And, the arm
guide lumen terminates at a distal tip of the elongated main body
so that the tool arm advances through the distal tip. Likewise, as
mentioned previously, the elongated main body typically has a
viewing scope lumen extending therethrough and terminating in the
distal tip.
[0024] In yet another aspect of the present invention, the tool
arms may have a distal end which is steerable by a variety of
mechanisms. For example, the distal end may be comprised of a
flexible tube having at least one pullwire attached thereto so that
manipulation of the at least one pullwire deflects the steerable
distal end. Or, the tool arm may have a steerable distal end which
comprises a flexible tube having shape memory material so that
emergence of the steerable distal end from the distal tip of the
main body allows deflection of the steerable distal end to a shape
memory position. Or, the tool arm may further comprise a deployment
frame extending from the distal tip of the main body, the frame
comprising at least two supports each attached to one of the at
least two tool arms so that manipulation of the deployment frame
deflects the attached tool arms.
[0025] In an additional embodiment of the present invention, the
endoluminal tool deployment system may be comprised of an elongated
main body having a distal end, a proximal end, and at least two arm
guide lumens extending over or through at least a distal section of
the elongated main body, wherein said arm guide lumens extend fully
to a distal tip of the main body, and at least two tool arms
adapted to extend through the arm guide lumens of the elongated
main body, said tool arms emerging from the distal tip of the main
body.
[0026] In still another aspect of the present invention, the
endoluminal tool deployment system comprises an elongated main body
having a distal end, a proximal end, and an arm guide lumen
extending through at least a distal section of the elongated main
body, wherein at least the distal section comprises a plurality of
adjacent links. The system further includes a means for selectively
deflecting the distal section within at least a single plane, and
at least one tool arm adapted to extend through the arm guide lumen
of the elongated main body.
[0027] In a further aspect of the present invention, a method is
provided for deploying one or more tools in an anatomical space. In
a preferred embodiment, the method comprises introducing a distal
end of a main body to said anatomical space, advancing a tool arm
from a tool deployment lumen in said main body into said anatomical
space, deflecting and positioning the tool arm to locate a distal
tip thereof adjacent to a target location within the anatomical
space, wherein a distal section of the arm is curved and laterally
stabilized in a single plane, and advancing a tool through a lumen
of the tool arm to the target location.
[0028] In some embodiments, deflecting and positioning comprises
tensioning a plurality of adjacent hinged links within the distal
section of the tool arm. The adjacent hinged links may be joined by
hinge pins which are disposed perpendicularly to the single plane
such that the pins stabilize the distal section and inhibit
deflection outside of the single plane. The method may further
comprise viewing the target location through a viewing scope
disposed in the main body, wherein the tool arm extends axially
from a distal tip of the main body from a location adjacent to the
viewing scope.
[0029] In some embodiments, an endoluminal system is provided
comprising an elongated main body having a proximal end, a distal
end sized for passage through a body lumen, and at least one lumen
extending between the proximal and distal ends. The system further
includes a torque transmitting feature which provides torque
transmission between the proximal and distal ends while the main
body is unlocked and able to form a desired configuration. In
addition, the system includes a locking mechanism which locks the
main body in the desired configuration. The at least one lumen may
be used for passage of any desired device, including, for example,
a viewing scope and optionally one or more tool arms. In addition,
the system typically includes a steering mechanism which steers the
main body to the desired configuration while the main body is
unlocked. In most embodiments, the steering mechanism comprises at
least one pullwire extending through the plurality of adjacent
links.
[0030] In preferred embodiments, at least a portion of the
elongated main body comprises a plurality of adjacent links. Torque
may be transmitted through the adjacent links by a variety of
torque transmitting features. For example, in some embodiments,
when the plurality of adjacent links comprises at least a first
link and an adjacent second link, the torque transmitting feature
comprising at least one protrusion or tooth from the first link
slidably engageable with at least one groove in the adjacent second
link, the torque transmitting feature providing torque transmission
through the portion of the main body while the links are
rotateable. In some embodiments, the at least one protrusion
comprises a pair of protrusions, each protrusion extending
outwardly from an outer surface of the first link in a
diametrically opposite position from the other protrusion.
Correspondingly, the at least one groove may comprise a pair of
grooves, each groove configured to accept one or the pair of
protrusions passing therein. When the first link comprises a first
domed ring having the outer surface and the adjacent second link
comprises a second domed ring having an inner surface, the outer
surface of the first domed ring is mateable with the inner surface
of the second domed ring along a longitudinal axis, and the rings
are rotateable away from the longitudinal axis. In some
embodiments, each groove comprises a first groove end and a second
groove end, the groove ends substantially aligned with the
longitudinal axis to allow sliding of the protrusions along the
grooves during rotation of the rings away from the longitudinal
axis. It may be appreciated that such protrusions may extend
inwardly from an inner surface and the grooves may be disposed on
the outer surface of an adjacent link to accept such protrusions.
Thus, the protrusions and associated grooves may function in a
similar manner in an inverse arrangement.
[0031] In other embodiments, the torque transmitting feature
comprises a protrusion or a pin from the first link slidably
engageable with a slot in the adjacent second link. This is an
example of a torque transmitting feature which provides torque
transmission by preventing disengagement of the adjacent links
while the main body is unlocked and able to form a desired
configuration. In some embodiments, the plurality of adjacent
engageable links comprises at least a first link and an adjacent
second link and the torque transmitting feature comprising at least
one pin from the first link slidably engageable with at least one
slot in the adjacent second link. Further, in some embodiments, the
at least one pin comprises a pair of pins, each pin extending
outwardly from an outer surface of the first link in a
diametrically opposite position from the other pin. Similarly, the
at least one slot comprises a pair of slots, each slot configured
to accept one or the pair of pins passing therethrough.
[0032] In preferred embodiments, the first link comprises a first
domed ring having the outer surface and the adjacent second link
comprises a second domed ring having an inner surface, the outer
surface of the first domed ring being mateable with the inner
surface of the second domed rings along a longitudinal axis, and
the rings being rotateable away from the longitudinal axis.
Typically, each slot comprises an elongate opening between a first
slot end and a second slot end, the slot ends substantially aligned
with the longitudinal axis to allow sliding of the pins through the
slots during rotation of the rings away from the longitudinal axis.
It may be appreciated that such pins may extend inwardly from an
inner surface and extend through slots on adjacent links. Thus, the
pins and associated slots may function in a similar manner in an
inverse arrangement.
[0033] In yet other embodiments, the torque transmitting feature
comprises a torque transmitting covering over the plurality of
adjacent engageable links to prevent disengagement of the adjacent
links. In some instances, the torque transmitting covering
comprises a snuggly fit sheath including reinforcements, such as a
braided material. The reinforcements may comprise nylon,
polyurethane, polyethylene, Teflon, metal, or polymer, for example.
Optionally, the reinforcements may be coated with a polymer or the
reinforcements may be covered with a separate polymer component.
Alternatively, the torque transmitting covering may comprise a
polymer coating over the links themselves.
[0034] In still further embodiments, an endoluminal device is
provided comprising an elongated main body having a proximal end, a
distal end, and at least one lumen extending between the proximal
and distal ends, at least a portion of the elongated main body
comprising at least a first link and an adjacent second link which
are rotateable relative to each other when unlocked, one of the at
least one lumen extending through the links having at least one
partition. An elongated shaft is present passing through one of the
at least one lumen in a manner to transmit torque by contacting the
least one partition. In addition, a locking mechanism is provided
which locks the links upon actuation by preventing rotation of the
links relative to each other.
[0035] In some embodiments, the at least one partition comprises an
inward protrusion. And, the at least one lumen extending through
the links may have a fluted shape forming the inward protrusions.
In other embodiments, the at least one partition comprises a
divider spanning across the one of the at least one lumen. The
shaft passes through the at least one lumen and is positioned
between partitions in each of the links. Torqueing of the plurality
of adjacent links is transmitted through the shaft and partitions.
For example, by applying torque to a first link, the first link
rotates about the longitudinal axis until the shaft contacts a
partition. Since the partitions are generally aligned, the shaft
will also contact partitions in a second link. Therefore, torque is
transmitted from the first link to the second link. This
transmission may be repeated through any number of links,
transmitting torque through a plurality of adjacent links.
[0036] In additional embodiments, the torque transmitting feature
comprises an oval shape of the plurality of adjacent links. And, in
other embodiments, the torque transmitting feature comprises a
plurality of wires or rods extending through the adjacent links. In
preferred embodiments, the plurality of rods comprises
approximately 8 to 64 rods. Torque is transmitted from link to link
through these torque transmitting features.
[0037] Further, a method of accessing is provided comprising
providing an elongated main body having a proximal end, a distal
end, a visualizing element and a locking mechanism, wherein the
main body is capable of forming a desired configuration in an
unlocked state and holding the desired configuration in a locked
state. The method further includes introducing the main body
through a body passageway in the unlocked state forming the desired
configuration so that the distal end reaches a target location,
actuating the locking mechanism to hold the main body in the
desired configuration, and viewing the target location with the use
of the visualizing element.
[0038] Introducing the main body may comprise allowing the main
body to assume a shape of the body passageway in the unlocked state
forming the desired configuration. Or, introducing the main body
may comprise steering the main body through the body passageway in
the unlocked state forming the desired configuration. In either
situation, in some embodiments, the main body comprises a plurality
of adjacent links so that actuating the locking mechanism comprises
holding the links in a fixed relation to each other. In particular,
the plurality of adjacent links sometimes comprises a plurality of
nestable elements so that holding the links comprises wedging the
links together to hold them by friction.
[0039] When the main body includes at least one lumen extending
between the proximal and distal ends, the method may further
comprise introducing an instrument through the at least one lumen.
In some embodiments, the instrument comprises a tool arm. When the
elongated main body further includes a visualizing lumen and the
visualizing element comprises an endoscope, the method may further
comprise positioning the endoscope within the visualizing
lumen.
[0040] Other objects and advantages of the present invention will
become apparent from the detailed description to follow, together
with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0041] FIG. 1 illustrates an embodiment of a system of the present
invention.
[0042] FIG. 2 illustrates the system of FIG. 1 in an assembled
arrangement.
[0043] FIG. 2A depicts the cross-section of the system of FIG. 2,
and FIG. 2B depicts an alternative cross-section.
[0044] FIGS. 3A-3D, 4-6 illustrate possible movements of the
steerable distal ends of the tool arms.
[0045] FIGS. 7A-7B illustrate the use of an embodiment of the
system to perform a mucosectomy.
[0046] FIGS. 8A-8C illustrate an embodiment of the main body in a
variety of positions.
[0047] FIG. 9A shows an embodiment of the shaft of the main body
comprised of a multiplicity of nestable elements, and FIG. 9B
provides an exploded view of these elements.
[0048] FIGS. 9C-9E provide cross-sectional views of various
nestable elements.
[0049] FIG. 10A provides an exploded view of nestable elements
having a pullwire extending through their centers and FIG. 10B
provides a cross-sectional view one of the nestable elements.
[0050] FIG. 10C illustrates the nestable elements of FIG. 10A with
the inclusion of liners and FIG. 10D provides a cross-sectional
view of one of the nestable elements.
[0051] FIGS. 10E-100 illustrate embodiments of the main body.
[0052] FIG. 11 illustrates an embodiment of a tool arm.
[0053] FIGS. 12A-12B, 13A-13B, 14 illustrate embodiments of
adjacent links disposed at the distal end of a tool arm.
[0054] FIG. 15 illustrates examples of possible deflections or
movements of an embodiment of the tool arm.
[0055] FIGS. 16A-16B illustrate another embodiment of a tool arm
comprising a plurality of adjacent links.
[0056] FIGS. 17, 17A-17C illustrate an embodiment of a tool arm
which is steerable to a predetermined arrangement.
[0057] FIGS. 18A-18B illustrate the creation of distinct curvatures
achieved by separate pullwires.
[0058] FIG. 19 illustrates two tool arms steered to a predetermined
arrangement.
[0059] FIG. 20 illustrates an embodiment including both links which
are steerable to a predetermined arrangement and links which are
unrestrictedly steerable.
[0060] FIGS. 21A-21B illustrate an embodiment of a tool arm
comprised of a slotted tube.
[0061] FIGS. 21C-21D illustrate an embodiment of a tool arm
comprised of a tube wherein a pullwire is positioned on the outside
of the tube.
[0062] FIGS. 21E-21F illustrate an embodiment of a tool arm
comprised of a polymer wall co-extruded with shape memory
material.
[0063] FIGS. 21G-21H illustrate a mechanism for steering the tool
arms including a deployment frame.
[0064] FIGS. 22A-22B, 23, 24 illustrate embodiments of the shaft of
the main body.
[0065] FIGS. 25A-25B provide a view of the proximal end of an
embodiment of the main body wherein two tool arms are present, each
including a steering cuff.
[0066] FIGS. 26, 27A-27B, 28A-28B illustrate embodiments of a
steering cuff.
[0067] FIGS. 29, 29A-29D illustrate embodiments of a tool having an
end effector in the form of various types of scissors.
[0068] FIG. 30 illustrates an embodiment of the tool having an end
effector in the form of gator toothed graspers.
[0069] FIG. 31 illustrates an embodiment of the tool having an end
effector in the form of an articulatable grasper.
[0070] FIGS. 32-36 illustrate embodiments of the tool having end
effectors in the form of various shaped retractors.
[0071] FIGS. 37A-37B illustrate grasping hooks inserted through
auxiliary lumens in the main body and FIG. 37C illustrates a
fixation device which may be deployed by the tool arms when such
grasping hooks are used in a plication procedure.
[0072] FIGS. 38, 39, 40A-40B illustrate alternative tools passed
through auxiliary lumens in the main body.
[0073] FIG. 41 illustrates a tool passed through an arm guide lumen
for use in conjunction with a tool arm.
[0074] FIG. 42 illustrates an arm used to cleanse a portion of the
main body, particularly the scope lens.
[0075] FIGS. 43A-43F illustrate a torque transmitting feature
utilizing a tooth and groove concept to maintain alignment of the
plurality of adjacent links at locations along its length.
[0076] FIGS. 44A-44D illustrate a torque transmitting feature
utilizing a pin and slot concept to maintain alignment of the
plurality of adjacent links at locations along its length.
[0077] FIGS. 45A-45C illustrate the use of a torque transmitting
covering over the plurality of adjacent links providing torque
transmission therethrough while the links are rotateable.
[0078] FIGS. 46A-46D illustrate cross-sectional views of a link
wherein one of the at least one lumen extending through the links
has at least one partition.
[0079] FIGS. 47A-47B illustrate a torque transmitting feature
wherein the links have an oval cross-section.
[0080] FIGS. 48A-48C illustrate a torque transmitting feature
comprising a plurality of rods extending through the adjacent
links.
DETAILED DESCRIPTION OF THE INVENTION
[0081] I. Overview
[0082] An embodiment of a system 2 of the present invention is
illustrated in FIG. 1. The system 2 includes an elongated main body
10 having a proximal end 12 and a distal end 14 terminating in a
distal tip 16. The main body 10 is used to access an internal
target location within a patient's body. Typically, the distal end
14 is passed through a body orifice and one or more naturally
occurring body lumens to the target location, such as in endoscopy,
while the proximal end 12 remains outside of the body. Therefore,
the main body 10 has a deflectable and/or steerable shaft 20,
either due to choice of material or design of the shaft 20 to
include links, hinges, coils or other similar structures to allow
deflection. Thus, FIG. 1 illustrates the main body 10 in a
deflected position wherein the body 10 includes curvatures. Such
deflection and/or steering may be useful in traversing body lumens
to the target location and is achievable by manipulation of a
handle 22 near the proximal end 12. It may be appreciated, however,
that the system 2 may be used in laparoscopic procedures wherein
such deflection and/or steering may be less utilized for placement
of the main body 10. In either case, rigidization of some or all
the shaft 20 may be desired, for example to provide a stable
visualization platform. Therefore, portions of the shaft 20 of the
main body 10 are lockable to maintain a desired shape and provide
rigidity, either due to choice of material or design of the shaft
20 to include locking mechanisms, as will be described in later
sections.
[0083] The main body 10 also includes at least one arm guide lumen
26 which extends over or through at least a distal section of the
main body 10, typically along the majority of the length of the
body 10 as shown. Here in FIG. 1, two arm guide lumens 26 are
shown, each extending from a position along the shaft 20 near the
proximal end 12 to the distal tip 16. In addition, the main body 10
includes a scope lumen 24 which extends through the shaft 20 to the
distal tip 16.
[0084] The system 2 also includes at least one tool arm 30, two are
shown in FIG. 1, each arm 30 of which is insertable through a
separate arm guide lumen 26 as indicated by dashed line. Each tool
arm 30 has a proximal end 32, a distal end 34 and a shaft 36
therebetween. The distal end 34 is steerable, such as by
manipulation of adjacent links as schematically indicated. Such
steerability may be controlled by a steering cuff 35 which is part
of the proximal end 32. The shaft 36 is typically flexible or
deflectable to allow deflection of the surrounding main body shaft
20. Each tool arm 30 additionally includes a tool deployment lumen
38 therethrough.
[0085] In this embodiment, the system 2 also includes at least one
tool 40, two are shown in FIG. 1. Each tool 40 includes a distal
end 42, a proximal end 44 and an elongate shaft 46 therebetween to
allow passage through the tool deployment lumen 38 of the arm 30.
Each tool 40 has an end effector 48 disposed at the distal end 42
and optionally a handle 50 at the proximal end 44 for manipulation
of the end effector 48 from outside the body. The tool 40 is
advanced so that the end effector 48 emerges from the distal end 34
of the arm 30.
[0086] FIG. 2 illustrates the system 2 of FIG. 1 in an assembled
arrangement. Here, the tool arms 30 are shown inserted through the
arm guide lumens 26 of the main body shaft 20. The steerable distal
ends 34 of the arms 30 protrude from the distal end 14 of the main
body 10 and the proximal ends 32 of the arms 30 protrude from the
proximal end 12 of the main body 10. As shown, the steering cuffs
35 are located at the proximal ends 32 of the arms 30. In addition,
the tools 40 are shown inserted through the tool deployment lumens
38 so that the end effectors 48 extend beyond the steerable distal
ends 34 of the arms 34. Likewise, the proximal ends 44 of the tools
40 with handles 50 are shown protruding from the steering cuffs 35.
Movement of the tools 40 against the steering cuffs 35 will actuate
steering of the distal ends 34 of the arms 30, as will be described
in later sections.
[0087] FIG. 2A provides a cross-sectional view of system 2 of FIG.
2. Since the shaft 20 of the main body 10 has a generally
cylindrical exterior in this embodiment, the cross-section of the
shaft 20 has a circular shape. It may be appreciated that
cylindrical shafts may alternatively have an elliptical, oval or
oblong cross-section. The shaft 20 has an outer diameter in the
range of about 5 to 25 mm, preferably approximately 14 mm. The
shaft 20 has a wall 21 with a thickness in the range of about 0.5
to 5 mm, preferably about 2-3 mm, defining an inner central lumen
23. Within the wall 21 lies various pushwires or pullwires 96,
hereinafter referred to as pullwires, for steering the main body 10
which may be present in a variety of quantities and arrangements.
Alternatively, the pullwires 96 may be present within the central
lumen 23. At least one arm guide lumen 26, two are shown, extend
through the central lumen 23. Each arm guide lumen 26 has an inner
diameter in the range of about 0.5 to 5 mm, preferably about 4 mm.
Positioned within the lumens 26 are the shafts 36 of the tool arms
30. And, likewise, positioned within the shafts 36 are the tools
40. FIG. 2A also illustrates the scope lumen 24 which has an inner
diameter in the range of about 2 to 10 mm, preferably about 4 mm.
In this embodiment, the two arm guide lumens 26 and the scope lumen
24 are arranged in a generally triangular pattern which is
maintained to the distal tip 16, however any suitable arrangement
may be used which allows viewing of the tool arms, particularly the
end effectors, by the scope. For example, FIG. 2B illustrates a
cross-section of an embodiment wherein the shaft 20 has an oval
shape and the arm guide lumens 26 and the scope lumen 24 are
generally aligned. Here, the scope lumen 24 is disposed between the
arm guide lumens 26 to facilitate viewing of the tool arms 30. Also
illustrated in FIGS. 2A and 2B are additional lumens which may be
used for various needs. For example, an irrigation/suction lumen
60, an insufflation lumen 56 and an auxiliary lumen 58 may be
present, each having an inner diameter in the range of about 0.5 to
5 mm, preferably about 2 mm. The auxiliary lumen 58 may be utilized
for a variety of uses, such as insertion of additional tools, such
as a macerator, a grasping tool, a cutting tool or a light source,
to name a few, for use in conjunction with the end effectors
present at the distal ends of the arms 30 or the distal ends of the
tools 40 inserted through the arms 30.
[0088] FIGS. 3A-3D illustrate a series of movements of the
steerable distal ends 34 of the tool arms 30. This series serves
only as an example, as a multitude of movements may be achieved by
the distal ends 34 independently or together. FIG. 3A illustrates
the distal tip 16 of the main body 10. The scope lumen 24 is shown
along with two arm guide lumens 26 terminating at the distal tip 16
and forming a triangular pattern as illustrated in FIG. 2A. FIG. 3B
illustrates the advancement of the distal ends 34 of the tool arms
30 through the arm guide lumens 26 so that the arms 30 extend
beyond the distal tip 16. FIGS. 3C-3D illustrate deflection of the
arms 30 to a preferred arrangement. FIG. 3C illustrates deflection
of the arms 30 laterally outward. This is achieved by curvature in
the outward direction near the base 64 of the steerable distal end
34. FIG. 3D illustrates deflection of the tip section 66 of the
distal end 34 laterally inward achieved by curvature in the inward
direction so that each arm 30 forms a hook shape. By facing the tip
sections 66 of the arms 30 toward each other as shown, the tip
sections 66 are positioned directly in the path of the scope lumen
24. Therefore, when a scope 28 is positioned within the scope lumen
24, the tip sections 66 of the tool arms 30 and any tools 40
advanced therethrough, will be visible through the scope 28. In
FIGS. 3C-3D, deflection of the arms 30 is achieved with the use of
adjacent links 62 in the areas of desired curvature. Embodiments of
such links 62 and other mechanisms of deflection will be discussed
in later sections. Further, the deflection of FIGS. 3A-3D are shown
to be within a single plane. However, various embodiments include
deflection in multiple planes. Likewise, the arms 30 are shown to
be deflected simultaneously in FIGS. 3A-3D, however the arms 30 may
be deflected selectively or independently.
[0089] FIGS. 4-6 illustrate additional possible movements of the
tool arms 30. For example, FIG. 4 illustrates axial movement of the
tool arms 30. Each tool arm 30 can independently move distally or
proximally, such as by sliding within the tool deployment lumen 38,
as indicated by arrows. Such movement maintains the arms 30 within
the same plane yet allows more diversity of movement and therefore
surgical manipulations. FIG. 5 illustrates rotational movement of
the tool arms 30. Each tool arm 30 can independently rotate, such
as by rotation of the arm 30 within the tool deployment lumen 38,
as indicated by circular arrow. Such rotation moves the arm 30
through a variety of planes. By combining axial, lateral and
rotational movement, the arms 30, and therefore the tools 40
positioned therethrough, may be manipulated through a wide variety
of positions in one or more planes.
[0090] FIG. 6 illustrates further articulation of the tool arms 30.
In some embodiments, the arms 30 are deflectable to form a
predetermined arrangement, such as illustrated in FIG. 3D.
Typically, when forming the predetermined arrangement, the arms 30
are steerable up until the formation of the predetermined
arrangement wherein the arms 30 are then restricted from further
deflection. In other embodiments, the arms are deflectable to a
variety of positions and are not limited by a predetermined
arrangement. Such an embodiment is illustrated in FIG. 6 wherein
the arms 30 articulate so that the tip sections 66 curl inwardly
toward the distal tip 16 of the main body 10. Again, the tip
sections 66 are positioned in front of the scope lumen 24 and scope
28 for viewing. Typically, the tip sections 66a are positioned on
opposite sides of a central axis 31 of the scope 28, wherein the
field of view (indicated by arrow 29) spans up to approximately 140
degrees, approximately 70 degrees on each side of the central axis
31. In addition, the depth of field is typically in the range of
approximately 1-10 cm.
[0091] As mentioned previously, the endoluminal tool deployment
system 2 of the present invention may be used to access a various
internal tissues or organs to perform a wide variety of surgical
procedures. FIGS. 7A-7B illustrate the use of an embodiment of the
system 2 to perform a mucosectomy, or removal of a portion of the
mucosa and/or submucosa of the stomach. FIG. 7A illustrates
advancement of the main body 10 through the esophagus E to the
stomach S. The main body 10 is then steered to a desired position
within the stomach S and the stomach mucosa M is visualized through
the scope 28 at the distal tip 16. Referring to FIG. 7B, the tool
arms 30 are then advanced through the main body 10 and articulated.
As mentioned, tools 40 may be advanced through the tool arms 30 or
an end effector 48 may be disposed at the distal end of each arm
30. Here, a grasper 80 is disposed at the distal end of one arm 30
and a cutter 81 is disposed at the distal end of the other arm 30.
The grasper 80 is used to grasp a portion of the mucosa M. The
grasped portion of mucosa M can then be elevated by rotation or
manipulation of the tool arm 30. This allows safe resection of the
portion of mucosa M by cutting with the use of the cutter 82, as
shown. Manipulation and resection of the tissue is visualized
throughout the procedure through the scope 28 which is aligned with
the tip sections 66, and therefore end effectors 48.
[0092] It may be appreciated that the systems, methods and devices
of the present invention are applicable to diagnostic and surgical
procedures in any location within a body, particularly any natural
or artificially created body cavity. Such locations may be disposed
within the gastrointestinal tract, urology tract, peritoneal
cavity, cardiovascular system, respiratory system, trachea, sinus
cavity, female reproductive system and spinal canal, to name a few.
Access to these locations may be achieved through any body lumen or
through solid tissue. For example, the stomach may be accessed
through an esophageal approach, the heart through a port access
approach, the rectum through a rectal approach, the uterus through
a vaginal approach, the spinal column through a port access
approach and the abdomen through a port access approach.
[0093] A variety of procedures may be performed with the systems
and devices of the present invention. The following procedures are
intended to provide suggestions for use and are by no means
considered to limit such usage: Laryngoscopy, Rhinoscopy,
Pharyngoscopy, Bronchoscopy, Sigmoidoscopy (examination of the
sigmoid colon, the sigmoid colon is the portion that connects the
descending colon to the rectum; primarily for diagnostic purposes,
however a biopsy procedure and trans anal micro surgery may be
performed for removing tumors), Colonoscopy (examination of colon;
for the removal of polyps and tumors or for biopsy), and
Esophagogastroduodenoscopy (EGD) which enables the physician to
look inside the esophagus, stomach, and duodenum (first part of the
small intestine). The procedure might be used to discover the
reason for swallowing difficulties, nausea, vomiting, reflux,
bleeding, indigestion, abdominal pain, or chest pain.
[0094] In addition, endoscopic retrograde cholangiopancreatography
(ERCP) may be achieved which enables the surgeon to diagnose
disease in the liver, gallbladder, bile ducts, and pancreas. In
combination with this process endoscopic sphincterotomy can be done
for facilitating ductal stone removal. ERCP may be important for
identification of abnormalities in the pancreatic and biliary
ductal system. Other treatments include Cholecystectomy (removal of
diseased gallbladder), CBD exploration (for common bile duct
stones), appendicectomy.(removal of diseased appendix), hernia
repair TAP, TEPP and other (all kinds of hernia), fundoplication
and HISS procedures (for gastro esophageal reflux disease), repair
of duodenal perforation, gastrostomy for palliative management of
late stage upper G.I.T. carcinoma), selective vagotomy (for peptic
ulcer disease), splenectomy (removal of diseased spleen), gastric
restrictive and malabsorbtive procedures (for morbid obesity),
upper and lower G.I. endoscopies (diagnostic as well as therapeutic
endoscopies), pyloroplastic procedures (for children's congenital
deformities), colostomy, colectomy, adrenalectomy (removal of
adrenal gland for pheochromocytoma), liver biopsy,
gastrojejunostomy, subtotal liver resection, gastrectomy, small
intestine partial resections (for infarction or stenosis or
obstruction), adhesions removal, treatment of rectum prolaps,
Heller's Myotomy, devascularization in portal hypertension,
attaching a device to a tissue wall and local drug delivery to name
a few.
[0095] II Main Body
[0096] As mentioned previously, the system 2 of the present
invention includes an elongated main body 10 having a proximal end
12 and a distal end 14 terminating in a distal tip 16. The main
body 10 may have a variety of features which are present in a
variety of combinations. Generally, the features include
deflectability, steerability, torqueability, lockability, lumens
for the passage of visualization elements, tool arms, and/or
instruments, and integral visualization elements, tool arms, and/or
instruments, to name a few. In addition, the main body may have any
of these features throughout any portion of the main body,
including the entire length of the main body or individual
subportions.
[0097] One embodiment of the main body 10 is illustrated in FIGS.
8A-8C, 9A-9D. In this embodiment, the main body 10 includes
deflectability and/or steerability and lumens for the passage of
visualization elements, tool arms, and/or instruments, such as
scope lumen 24. FIG. 8A illustrates the main body in a straight
configuration. Since the main body 10 is used to access an internal
target location within a patient's body, the main body 10 has a
deflectable and/or steerable shaft 20. Thus, FIG. 8B illustrates
the main body 10 having various curvatures in its deflected or
steered state. In preferred embodiments, the main body 10 is
steerable so that the main body 10 may be advanced through
unsupported anatomy and directed to desired locations within hollow
body cavities. In some embodiments, the main body 10 includes a
first section 90 which is proximal to a second section 92, as
indicated in FIG. 8B. Although both sections 90, 92 are steerable,
the first section 90 may be locked in place while the second
section 92 is further articulated. This is illustrated in FIG. 8C,
wherein the first section 90 is shown in a locked position
unchanged from FIG. 8B and the second section 92 is shown in
various retroflexed positions. In retroflexion, the second section
92 is curved or curled laterally outwardly so that the distal tip
16 is directed toward the proximal end 12 of the main body 10.
Optionally, the second section 92 may also be locked, either in
retroflexion or in any other position.
[0098] Steering and locking may be achieved by any suitable
mechanisms. In some embodiments, the shaft 20 comprises a
multiplicity of nestable elements 260, as illustrated in FIG. 9A.
FIG. 9B provides an exploded view of the nestable elements 260 of
FIG. 9A. Here it can be seen that the elements 260 are disposed so
that a distal surface 262 of one element 260 coacts with a proximal
surface 264 of an adjacent element. Each of the nestable elements
260 includes one or more pullwire lumens 98 through which pullwires
96 pass. The pullwires 96 are used to hold the elements 260 in
nesting alignment and to provide steering and locking. The
pullwires 98 preferably are made from a superelastic material, e.g.
nickel titanium alloy, to provide flexibility, kink-resistance and
smooth movement of the pullwires 96 through the pullwire lumens 98.
Alternatively, the pullwires 96 may be made from braided stainless
steel, a single stainless steel wire, poly-para-phenylene
terephthalamide (such as Kevlar.RTM.), a high tensile strength
monofilament thread, combinations thereof or any suitable
materials.
[0099] Generally, the adjacent surfaces 262, 264 are contoured to
mate so that when the pullwires 96 are relaxed, surfaces 262, 264
can rotate relative to one another. This allows the shaft 20 to
form curvatures throughout its length in any direction. Each
pullwire 96 is fixed at its distal end to a specific element 260
along the shaft 20 or to the distal tip 16. When tension is applied
to a specific pullwire 96, a curvature forms in the shaft 20
proximal to the fixation point, thus steering the shaft 20. The
pullwires 96 may be arranged in various patterns to achieve
steering in various directions. For example, FIG. 9C is a
cross-sectional view of the shaft 20 in the first section 90 of
FIG. 8B. Here, eight pullwires 96 (four pullwires 96a and four
pullwires 96b) are shown passing through the wall 21. Four
pullwires 96a terminate at the distal end of the first section 90
and are used to steer the first section 90. Since the pullwires 96a
are equidistantly positioned, applying tension to the pullwires
96a, either individually or in combination, steers the first
section 90 in any desired direction. The first section 90 may be
locked in place by holding the tension in the pullwires 96a using
any suitable mechanisms. For example, tension may be applied to the
pullwires 96 simultaneously until the elements 260 are compressed
to a state in which they are locked by friction wherein the tension
is held.
[0100] FIG. 9D is a cross-sectional view of the shaft 20 in the
second section 92 of FIG. 8B. Here, four pullwires 96b are shown
passing through the wall 21. These pullwires 96b extended through
the first section 90, as indicated in FIG. 9C, and terminate near
the distal tip 16. Since the pullwires 96b are equidistantly
positioned, applying tension to the pullwires 96b, either
individually or in combination, steers the second section 92 in any
desired direction. Since the pullwires 96b also pass through the
first section 90, such steering may also effect the curvature in
the first section 90 when the first section is not locked. However,
such effects are minimal, may be counteracted or compensated for by
steering in the first section 90, and may be avoided by locking.
The second section 92 may be also be locked in place by holding the
tension in the pullwires 96b using any suitable mechanisms.
[0101] In this embodiment, the wall 21 extends continuously from
the proximal end 12 to the distal end 14 with the first and second
sections 90, 92 determined by the termination points of the
pullwires 96 which extend therethrough. Alternatively, the first
and second sections 90, 92 may be comprised of separate shafts
which are coaxially positioned adjacent to one another.
[0102] In the embodiment illustrated in FIG. 9B, the nestable
elements 260 have a central lumen 23 which passes through the
length of the main body 10. Instruments or tools may be passed
through this lumen 23, as indicated in FIGS. 9C-9D, or tubes may be
present within the lumen 23 through which instruments or tools may
be passed. In preferred embodiments, the nestable elements 260 have
holes formed therein so that lumens are formed by alignment of the
holes when the elements 260 are stacked. For example, FIG. 9E
provides a cross-sectional view of a nestable element 260
illustrating the holes formed therein which serve as lumens. As
shown, a scope lumen 24, arm guide lumens 26, and auxiliary lumens
58 extend through the center of the element 260 while pullwire
lumens 98 are located around the periphery.
[0103] It may be appreciated that pullwire lumens 98 may also
extend through the center of the element 260. For example, FIG. 10A
illustrates an embodiment having a pullwire 96 which extends
through the center of the stacked nestable elements 260. FIG. 10A
provides an exploded view of the nestable elements 260 wherein the
elements 260 are disposed so that a distal surface 262 of one
element 260 coacts with a proximal surface 264 of an adjacent
element. As shown, each of the nestable elements 260 includes a
pullwire lumen 98 through its center. FIG. 10B provides a
cross-sectional view of a nestable element 260 of FIG. 10A. As
shown, the nestable element 260 includes a locking pullwire lumen
98c having a pullwire 96c therethrough in the center of the element
260 surrounded by various other lumens, such as a scope lumen 24,
arm guide lumens 26, auxiliary lumen 58 and various pullwire lumens
98 used for steering. Once the elements 260 are positioned in a
desired arrangement, the shaft 20 may be locked in place by the
central pullwire 96c. Applying tension to the pullwire 96c
compresses the elements 260 to a state in which they are locked by
friction wherein the tension is held.
[0104] In addition, liners 266 may be passed through any of the
lumens of the stacked nestable elements 260. Such liners 266 form
create a continuous lumen connecting the lumen holes of the
nestable elements 260. FIG. 1C illustrates the nestable elements
260 of FIG. 10A with the inclusion of liners 266 passing through,
for example, the arm guide lumens 26. Likewise, FIG. 10D provides a
cross-sectional view of a nestable element 260 of FIG. 10C. Here,
liners 266 are shown positioned through the nestable element 260
forming lumens 24, 26, 58 therethrough. It may also be appreciated
that liners 266 may extend through pullwire lumens 98 as well. The
liners 266 may be coated on their luminal surface with a
hydrophilic coating for reducing friction or the liners 266 may be
comprised of a lubricious polymer such as Teflon.RTM.,
fluoroethylene polymer (FEP) or the like.
[0105] As mentioned previously, it may be appreciated that the
shaft 20 of the main body 10 may have a variety of structures to
provide features such as deflectability, steerability,
torqueability, lockability, visualization and various tools, etc.
Exemplary embodiments of structures which provide deflectability,
steerability and or lockability are described above and provided in
co-pending U.S. patent application Ser. No. 10/281,462 filed Oct.
25, 2002, which is a continuation in part of U.S. patent
application Ser. Nos. 10/173,203, 10/173,227, 10/173,238 and
10/173,220, all of which were filed on Jun. 13, 2002 and herein
incorporated by reference for all purposes. Also of interest and
incorporated by reference for all purposes are co-pending U.S.
patent application Ser. Nos. 10/281,461 and 10/281,426 each filed
on Oct. 25, 2002. It is understood that lockablility includes
locking the main body in a desired configuration to maintain one or
more curvatures along its length. Thus, in these instances the main
body is shape lockable. Structures which provide torqueability will
be described in later sections, however it is understood that these
features are applicable to any of the embodiments described
herein.
[0106] In addition, it may be appreciated that the main body 10 may
be comprised of a traditional endoscope or laparoscope. Exemplary
embodiments of traditional endoscopes are provided in U.S. Pat.
Nos. 3,948,251; 4,036,218; 4,201,198; 4,224,929; 4,988,171;
5,020,539; 5,035,231; 5,068,719; 5,170,775; 5,172,225; 5,187,572;
and 5,196,928, all of which are herein incorporated by reference
for all purposes. FIG. 10E illustrates the shaft 20 of the main
body 10 comprising a traditional endoscope 650, or other endoscope,
which includes a visualizing element 652 and at least one light
source 654. In this embodiment, the endoscope 650 includes two arm
guide lumens 26 for the passage of tool arms 30. The tool arms 30
each have end effectors 48, as shown, or tools 40 which have end
effectors 48 may be advanced through a tool deployment lumen 38 in
each arm 30. FIG. 10F provides a cross-sectional view of the shaft
20 of FIG. 10E. FIG. 10G illustrates the shaft 20 of the main body
10 comprising a plurality of steerable and/or lockable nestable
elements 260 and a traditional endoscope 650, or other endoscope,
passing therethrough which includes a visualizing element 652 and
at least one light source 654. The endoscope 650 may be advanceable
and/or retractable through an endoscope lumen 656 in the shaft 20
of the main body 10 or may be fixed within the shaft 20. The
endoscope 650 may be positioned so that a distal end 658 of the
endoscope 650 is flush with the distal tip 16 of the shaft 20 or is
disposed at any position along the shaft 20 including extending
beyond the distal tip 16, as shown. FIG. 10H provides a
cross-sectional view of FIG. 10G. Here, the wall 21 of the shaft 20
is more clearly visible including pullwires 96 for steering and/or
locking. Further, the shaft 20 of the main body 10 may include one
or more arm guide lumens 26 for the passage of tool arms 30, as
shown in FIG. 101. The tool arms 30 each have end effectors 48, as
shown, or tools 40 which have end effectors 48 may be advanced
through a tool deployment lumen 38 in each arm 30. FIG. 10J
provides a cross-sectional view of FIG. 10I.
[0107] FIG. 10K illustrates the shaft 20 of the main body 10 having
an integral or integrated visualizing element 652 and at least one
light source 654. Again, the shaft 20 comprising a plurality of
nestable elements 260 for steering and/or locking. Optionally, the
shaft 10 may also include a lumen 660, illustrated in FIGS.
10M-10N, for passage of a variety of tools, instruments or devices
therethrough, including tool arms 30. Or, as shown in FIG. 10O, the
shaft 20 having an integral visualizing element and at least one
light source 654 may have individual arm guide lumens 26 for the
passage of tool arms 30. It may also be appreciated that the tool
arms 30 of FIG. 10O may alternatively be fixed or integral with the
shaft 20.
[0108] The visualizing elements 652 of any of the embodiments
include elements which transmit and/or detect a visual image. For
example, such visualizing elements 652 may include a coherent fiber
optic bundle, an ultrasound device, and/or charge coupled devices
(CCD) for operation in the visible spectrum of electromagnetic
radiation, the infrared spectrum of electromagnetic radiation, the
ultraviolet spectrum of electromagnetic radiation, and/or the x-ray
spectrum of electromagnetic radiation.
[0109] III Tool Arms
[0110] As mentioned previously, system 2 also includes at least one
tool arm 30, each arm 30 of which is insertable through a separate
arm guide lumen 26 in the main body 10. As shown in FIG. 11, each
tool arm 30 has a proximal end 32, a distal end 34 and a shaft 36
therebetween. The distal end 34 is steerable, such as by
manipulation of adjacent links 62 as schematically indicated. Such
stecrability may optionally be controlled by a steering cuff 35,
disposed within the proximal end 32. Each tool arm 30 additionally
includes a tool deployment lumen 38 therethrough.
[0111] A. Distal End
[0112] FIGS. 12A-12B illustrate an embodiment of adjacent links 62
disposed at the distal end 34 to allow steerability of the arm 30.
Here, links 62 are pivotally connected by hinge structures 100. As
shown in FIG. 12A, the links 62 are shaped so that connection by
the hinge structures 100 creates gaps 102 between the links 62
directly opposite to the hinge structures 100. A pullwire 96 is
shown extending through the links 62 and terminating at a fixation
point 104. Referring now to FIG. 12B, retraction of the pullwire 96
draws the links 62 together, minimizing the gaps 102 between the
links 62. Due to the shape and arrangement of the links 62, this
movement creates a curve in the arm 30 as shown. The distal end 34
may be steered to have any curvature between substantially straight
and a maximum curvature wherein the gaps 102 are completely closed
or another limiting feature is established. In some embodiments, up
to 360 degree curvature of the distal end 34 is possible. The
distal end 34 may be returned to a straightened position by
advancement of the pullwire 96 or by the presence of a spring which
will straighten the distal end 34 by recoil force.
[0113] FIGS. 13A-13B illustrate a similar embodiment of adjacent
links 62 disposed at the distal end 34 to allow steerability of the
arm 30. Again, links 62 are pivotally connected by hinge structures
100. However, as shown in FIG. 13A, the links 62 are shaped so that
connection by the hinge structures 100 creates gaps 102 between the
links 62 on both sides of the hinge structures 100. A pullwire 96
is shown extending through the links 62 and terminating at a
fixation point 104. Referring now to FIG. 13B, retraction of the
pullwire 96 draws the links 62 together, minimizing the gaps 102
between the links 62 along the pullwire 96 and maximizing the gaps
102 on the opposite side of the hinge structures 100. Due to this
shape and arrangement of the links 62, this movement creates a
curve in the arm 30 as shown. The distal end 34 may also be
returned to a straightened position by advancement of the pullwire
96 or by the presence of a spring which will straighten the distal
end 34 by recoil force. However, in this embodiment, the distal end
34 may be deflected or curved in the opposite direction by
continued advancement of the pullwire 96. Advancement of the
pullwire 96 minimizes the gaps 102 on the opposite side of the
hinge structures 100 causing a curvature in the opposite direction.
Likewise, a spring may be present to straighten the distal end 34
from a curvature in this opposite direction.
[0114] FIG. 14 illustrates an embodiment similar to the embodiment
illustrated in FIGS. 13A-13B. The links 62 are shown pivotally
connected by hinge structures 100. Here the hinge structures 100
comprise pivot pins 106 which are arranged in parallel to limit
deflection to a single plane. In some embodiments, the hinge
structures comprise male and female bearing surfaces which define
axes, wherein the axes are disposed in parallel to limit deflection
of the distal section to within the single plane. The links 62 are
shaped so that connection by the pivot pins 106 creates gaps 102
between the links 62. Closure of the gaps 102 on one side of the
pivot pins 106 simultaneously opens gaps on the other side of the
pins 106. FIG. 14 also illustrates an end effector 48 of a tool 40
which has been advanced through the tool deployment lumen 38 of the
arm 30.
[0115] FIG. 15 illustrates examples of possible deflections or
movements of the tool arms 30. Here, two arms 30 are shown emerging
from the distal tip 16 of the elongated main body 10. The distal
end 34 of each arm 30 is steerable and comprised of a plurality of
adjacent links 62. The arm 30 on the left is shown steered to a
position wherein the tip section 66 is curled inwardly forming an
almost complete circular shape. In contrast, the arm 30 on the
right is shown steered to a position wherein the tip section 66 is
deflected slightly inwardly forming an arc shape. Thus, the arms 30
may be independently steerable to varying degrees of curvature.
Preferably, the arms 30 are steerable inwardly to perform surgical
procedures in cooperation and to maintain visibility through the
centrally located scope.
[0116] FIGS. 16A-16B illustrate another embodiment of a tool arm 30
comprising a plurality of adjacent links 62. Here, the links 62 are
comprised of disks 110 having faces which are angled to form gaps
102 between the disks 110 when the disks 110 are stacked. The disks
110 are connected by one or more wires or ribbons 112. In this
embodiment, illustrated in FIG. 16B, two ribbons 112 are present,
each at diametrically opposite positions within the wall of each of
the stacked disks 110 so that the angled faces are aligned between
the ribbons 112. The ribbons 112 may be embedded in the wall,
co-molded with the stacked disks or simply advanced through a lumen
in the wall. The ribbons 112 maintain relative position of the
disks 110 and stabilize the steerable distal end 34 to be
deflectable in only a single plane. Also shown in FIG. 16B, lumens
114 are present between the ribbons 112 for positioning pullwires
96 therethrough. The pullwires 96 pass through the angled portions
of the disks 110 so that application of tension to a pullwire 96
draws the angled faces of the disks 110 together to close the gaps
102 therebetween. This in turn widens the diametrically opposite
gaps 102 creating curvature in the stack.
[0117] As mentioned previously, in some embodiments, the arms 30
are deflectable to form a predetermined arrangement, such as
previously illustrated in FIG. 3D. Typically, when forming the
predetermined arrangement, the arms 30 are steerable up until the
formation of the predetermined arrangement wherein the arms 30 are
then restricted from further deflection. FIG. 17 illustrates an
embodiment of such an arm 30 comprising a plurality of adjacent
links 62 wherein the arm 30 is steerable to a predetermined
arrangement. As shown, the distal end 34 comprises a base 64 which
deflects the distal end 34 outwardly and a tip section 66 which
deflects inwardly. Between the base 64 and tip section 66 lies a
spacer 68 which is rigid. The spacer 68 may be considered a larger
elongate link or simply a straight section. Usage of such spacers
68 is optional and may be used to create specific predetermined
arrangements. FIG. 17A is an enlarged view of the tip section 66
which illustrates the shapes of the links 62 which are pivotally
connected by hinge structures 100 formed into the links 62. Gaps
102 are present on opposite sides of the structures 100 to allow
curvature of the distal end 34. The size of the gaps 102 will vary
due to varying sizes and shapes of the links 64 so that closure of
the gaps 102 forms a specific curvature. This is most easily seen
in FIGS. 17B-17C. FIG. 17B illustrates links 62 of the base 64
having varying shapes to create gaps 102 of varying size. As shown,
a pullwire 96 extends through the links 62 along the gaps 102.
Applying tension to the pullwire 96 draws the links 62 together to
close the gaps 102 and to form a predetermined curve as in FIG.
17C.
[0118] The predetermined arrangement of FIG. 17 includes curvatures
in opposite directions, the base 64 curving laterally outwardly and
the tip section 66 curving laterally inwardly. These distinct
curvatures may be achieved by separate pullwires 96. For example,
as shown in FIG. 18A, a first pullwire 97a may be positioned along
one side of the tool arm 30 terminating at a fixation point 104a
located midway along the distal end 34. The links 62 which lie
proximally of this fixation point 104a form the base 64. A second
pullwire 97b may be positioned along the opposite side of the arm
30 terminating at a fixation point 104b located at the tip of the
distal end 34. Generally, the links 62 which lie between the
fixation point 104a and the fixation point 104b form the tip
section 66. Referring now to FIG. 18B, by applying tension to the
first pullwire 97a, the base curves laterally outwardly, and by
applying tension to the second pullwire 97b, the tip section curves
laterally inwardly.
[0119] FIG. 19 illustrates two tool arms 30 which are steered to a
predetermined arrangement. Such steering is achieved with the use
of pullwires 96 as illustrated in FIGS. 18A-18B. Fixation points
104b are visible while fixation points 104a are hidden within the
arms 30. As shown, the links 62 are varied in size and shape to
form this arrangement when tension is applied to the pullwires 96.
For example, the links 62 are generally larger thought the bases 64
and smaller through the tip sections 66. Further, this embodiment
includes stabilizers 120 which pass through the arms 30 for
stability.
[0120] In some embodiments, the steerable distal end 34 includes
both types of links, links which are steerable to a predetermined
arrangement and links which are unrestrictedly steerable. For
example, FIG. 20 illustrates an embodiment wherein the base 64 is
comprised of links 62 which are appropriately shaped and sized to
deflect laterally outwardly to form a predetermined arrangement.
Such deflection is achieved with a pullwire which is hidden from
view and terminates midway along the distal end 34. In this
embodiment, the tip section 66 is comprised of links 62 which are
appropriately sized and shape to deflect laterally inwardly in an
unrestricted fashion. The links 62 of the tip section 66 are hinged
together by pivot pins 106 to provide support throughout the
unrestricted movement. In addition, a tool 40 having an end
effector 48 is shown passed through the tool deployment lumen 38 in
the arm 30. Also shown in FIG. 20, the arms 30 are rotated to lie
in different planes, a feature which has been described in previous
sections.
[0121] It may be appreciated that the embodiments which include
links may have any number of links. For example, the steerable
distal end 34 may have two links 62 which are hinged together by a
hinge structure 100. In this example, the shaft 36 would direct the
first link 62 in a first direction and the hinge structure 100
would turn the distal tip 16 towards a second direction. The
addition of more linkages 62 would create a smoother curve and/or
allow multiple curves throughout the steerable distal end 34.
[0122] Although the previous embodiments of the tool arms 30 have
been comprised of a plurality of adjacent links, it may be
appreciated that the arms 30 may be comprised of material in any
suitable form. For example, each arm 30 may be comprised of a
polymeric tube which has been pre-shaped, such as by heat setting,
to form a desired curvature. The polymeric tube is comprised of a
material which is sufficiently flexible to allow straightening of
the curve for delivery through the arm guide lumen 26 and
adequately flexible to allow recoiling of the arm 30 to form the
desired curvature upon emergence from the lumen 30.
[0123] In another embodiment, each arm 30 is comprised of a slotted
tube, as illustrated in FIGS. 21A-21B. Referring to FIG. 21A, a
tube 130 has a series of slots 132 along its length. In this
embodiment, the slots 132 are present along one side of the tube
130 however, it may be appreciated that the slots 132 may be
present on both sides of the tube or along any portion of the tube
which is desired to deflect. Referring back to FIG. 21A, the
pullwire 96 is positioned within the tube along the slots 132 and
fixed to the tube 130 at a fixation point 104. By applying tension
to the pullwire 96, the tube 130 is deflected toward the pullwire
96 as shown in FIG. 21B. The presence of the slots 132 allows the
tube 130 to be comprised of a relatively rigid or thick material
while deflecting and curving with minimal buckling or impedance by
the tube 130. It may be appreciated that the tube 130 of FIGS.
21A-21 B may alternatively be a solid-walled tube without slots
comprised of a thinner or more flexible material which itself
allows deflection and curvature with minimal buckling or impedance.
Further, each of the following embodiments illustrating various
tool arms 30 may be comprised of solid-walled or slotted tubes, or
any other suitable tube construction.
[0124] FIGS. 21C-21D illustrate an embodiment of the arm 30
comprised of a tube 130 wherein a pullwire 96 is positioned on the
outside of the tube 130 and fixed to the tube 130 at a fixation
point 104. By applying tension to the pullwire 96, the tube 130 is
deflected toward the pullwire 96 as shown in FIG. 21D. Since the
pullwire 96 is disposed outside of the tube 130, the pullwire 96
forms a tether to the fixation point 104 and does not follow along
the surface of the tube 130.
[0125] FIGS. 21E-21F illustrate an embodiment of the arm 30
comprised of a polymer wall co-extruded with shape memory material,
such as nitinol wire. FIG. 21E illustrates the arm 30 in a
straightened position, wherein the arm 30 is passed through the arm
guide lumen 26, and a curved position, wherein the arm 30 recoils
to a shape-memory curve. FIG. 21F provides a cross-sectional view
of the arm 30 of FIG. 21E illustrating shape-memory material 280
distributed within the wall of the arm 30.
[0126] FIGS. 21G-21H illustrate an alternative mechanism for
steering the tool arms 30. Referring to FIG. 21G, the shaft 20 of
the main body 10 is illustrated having a pair of tool arms 30
extending therefrom. Surrounding the arms 30 lies a deployment
frame 290. The frame 290 is comprised of a semi-rigid or rigid
material, such as stainless steel wire, which provides sufficient
strength to apply force to the arms 30. The frame 290 comprises at
least two supports 292, each extending from the distal tip 16 of
the shaft 20 and connecting at a peak 294. Each support 292
attaches to a tool arm 30 at an attachment point 296. The frame 290
also includes an actuation support 298 extending from the distal
tip 16 to the peak 294. The arms 30 and supports 292, 298 advance
from the distal tip 16 of the main body 10 to a desired location in
the body in a straight configuration as illustrated in FIG. 21G.
Referring to FIG. 21H, application of tension to the actuation
support 298 draws the peak 294 toward the distal tip 16 causing the
supports 292 to bow or bend outward drawing the attached arms 30
outward. Likewise, the supports 292 may include hinges wherein the
supports 292 would bend at the hinge. Although FIG. 21H illustrates
the arms 30 bending at the attachment points 296, it may be
appreciated that the arms 30 may bend at any location. Such bending
directs the tool deployment lumens 38 toward each other to
facilitate coordination of tools passed therethrough. Movement of
the peak 294 proximally and distally varies the curvature of the
arms 30 and provides steering. The frame 290 also serves to create
a working space, restricting surrounding tissue from encroaching on
the arms 30 and tools 40.
[0127] In most embodiments, the distal ends of the tool arms are
lockable to maintain a deflected position. Such locking may be
achieved by any suitable mechanisms. When the tool arm is steerable
by manipulation of pullwires or pushwires, the wires may be held in
place to lock the distal end in a desired position. In embodiments
comprising a multiplicity of nestable elements through which
pullwires pass, the pullwires are typically used to hold the
elements in nesting alignment and to provide steering and locking.
By applying tension to the pullwires simultaneously, the elements
may be compressed to a state in which they are locked by friction
wherein the tension is held. Other locking mechanism may also be
used. Further, the tool arms may be locked rotationally and axially
within the main body to maintain positioning of the tool arm in
relation to the main body.
[0128] B. Shaft
[0129] As described previously, the shaft 36 of the tool arm 30
passes though the main body 10. In embodiments wherein the main
body 10 is deflectable, the shaft 36 is also deflectable. However,
although it is desired that the shaft 36 be laterally deflectable,
it is also desired that the shaft 36 maintain axial rigidity. Any
suitable construction may be used, including a braid reinforced
torqueable tube. Additional embodiments are described below.
[0130] FIGS. 22A-22B illustrate embodiments of the shaft 36
comprising a coil 140. Here, illustrated in FIG. 22A, the turns of
the coil 140 lie adjacent to each other to prevent axial movement
and maintain axial rigidity. However, the coil configuration allows
deflection of the shaft 36 as shown in FIG. 22B.
[0131] In another embodiment, illustrated in FIG. 23, the shaft 36
comprises a plurality of adjacent linkages 150. Here, each linkage
150 includes a pair of protruding structures 152 on its face and a
pair of notches 154 on its base. The protruding structures 152 and
notches 154 are both arc shaped so that the protruding structures
152 of one linkage 150 rotateably interfit with the notches 154 of
an adjacently stacked linkage 150. By alternating the position of
the pairs of protruding structures 152 and notches 154 as shown in
FIG. 23, the shaft 36 is flexible in both lateral bending
directions while maintaining stiffness axially and in torsion. Also
shown are flared lumens 158 which pass through the protruding
structures 152 and the wall of the shaft 36. Flaring allows for a
rod or wire passed therethrough to move within the lumen 158 as a
linkage 150 rotates over the protruding structure 152. Round
pullwire lumens 156 pass through the notches 154 and the wall of
the shaft 36 as shown. The rod or wire holds the linkages 150 in a
stacked configuration and optionally may be used to steer the shaft
36.
[0132] In another embodiment, illustrated in FIG. 24, the shaft 36
comprises a plurality of adjacent linkages 160 which are also
stacked to provide lateral deflection while maintaining axial
rigidity. Here, each linkage 160 includes a pair of protruding
structures 162 on its face and a pair of notches 164 on its base.
The protruding structures 162 and notches 164 are both arc shaped
so that the protruding structures 162 of one linkage 160 rotateably
interfit with the notches 164 of an adjacently stacked linkage 160.
By alternating the position of the pairs of protruding structures
162 and notches 164 as shown in FIG. 24, the shaft 36 is flexible
in both lateral bending directions while maintaining stiffness
axially and in torsion. In this embodiment, the linkages 150
include a central lumen 166 through which a rod or wire is passed.
The rod or wire is used to hold the linkages 60 in the stacked
configuration.
[0133] C. Proximal End
[0134] The proximal end 32 of the tool arm 30 may simply terminate
in an endpiece or connector for passage of a tool 40 through its
tool deployment lumen 38. However, the proximal end 32 may
optionally include a steering cuff 35 for steering the tool arm 30,
particularly for steering its distal end 34.
[0135] FIG. 25A illustrates an embodiment of the proximal end 12 of
the main body 10 wherein two tool arms 30 are present, each
inserted through an arm guide lumen 26 in the shaft 20 of the main
body 10. As shown, each tool arm 30 includes a steering cuff 35
which remains outside of the main body 10 and the tool deployment
lumen 38 is accessible through the steering cuff 35. FIG. 25B
illustrates an alternative embodiment of the proximal end 12
wherein two tool arms 30 are present, each inserted through an arm
guide lumen 26 through the handle 22 of the main body 10. Again,
each tool arm 30 includes a steering cuff 35 which remains outside
of the main body 10 and the tool deployment lumen 38 is accessible
through the steering cuff 35. This embodiment also includes a
locking mechanism 170 on each arm 30. The locking mechanism 170 can
be manipulated, such as by turning a lever 172 shown in FIG. 25B,
to lock the distal end 34 or the tool arm 30 in a steered or
deflected position.
[0136] FIG. 26 illustrates an embodiment of a steering cuff 35
disposed at the proximal end 32 of a tool arm 30 wherein a tool 40
is passed therethrough. In this embodiment, the tool arm 30
includes four pullwires 96 (three are visible in FIG. 26) which are
equidistantly positioned around the perimeter of the shaft 36. The
pullwires 96 are used to steer the distal end 34 of the arm 30 as
previously described. As shown, the tool 40 has a distal end 42
with an end effector 48 which emerges from the distal end 34 of the
arm 30. Likewise, the tool 40 has a proximal end 44 which emerges
from the steering cuff 35. In this embodiment, the steering cuff 35
has a funnel shape wherein one end is attached to at least the
pullwires 96 and typically additionally to the arm 30 itself.
Deflection of the proximal end 44 of the tool 40, indicated by
angular arrow 180, presses the proximal end 44 against the steering
cuff 35 which rotates the steering cuff 35 to a deflected position,
indicated by dashed line. Such rotation applies tension to
pullwires 96 diametrically opposite to the deflected position as
indicated by arrows 182. Such tension steers the distal end 34 of
the arm 30. Thus, manipulation of the tool 40 within the steering
cuff 35 can be used to steer the distal end 34 of the arm 30.
[0137] FIGS. 27A-27B and FIGS. 28A-28B illustrate another
embodiment of a steering cuff 35. Here, the steering cuff 35 has a
sphere shape and is disposed at the proximal end 32 of the tool arm
30. The tool 40 is passed through a lumen 184 in the sphere shaped
cuff 35 so that the distal end 42 of the tool emerges from the
distal end 34 of the arm 30 and the proximal end 44 remains outside
of the cuff 35 as shown. In this embodiment, the tool arm 30
includes four pullwires 96 (three are visible) which are
equidistantly positioned around the perimeter of the shaft 36. The
pullwires 96 are used to steer the distal end 34 of the arm 30 as
previously described. FIG. 27A illustrates the pullwires 96
emerging from the shaft 36 of the arm 30 and attached to the
surface of the sphere shaped cuff 35. Likewise, FIG. 27B provides a
similar view, however in this case the arm 30 is cutaway to reveal
the pullwires 96 extending through lumens in the shaft 36 and the
tool 40 extending through the tool deployment lumen 38. FIG. 28A
illustrates the embodiment in the straight position. Deflection of
the proximal end 44 of the tool 40, indicated by angular arrow 180,
presses the proximal end 44 against the steering cuff 35 which
rotates the steering cuff 35 to a deflected position, as shown in
FIG. 28B. Such rotation applies tension to pullwires 96
diametrically opposite to the deflected position as indicated by
arrow 182. Such tension steers the distal end 34 of the arm 30.
Thus, manipulation of the tool 40 within the steering cuff 35 can
be used to steer the distal end 34 of the arm 30.
[0138] It may be appreciated that the embodiments of the steering
cuff 35 depicted in FIG. 26 and FIGS. 27A-27B, 28A-28B may include
any number of pullwires 96 for any desired level of steerability.
For example, in each embodiment, two pullwires 96 may be present
disposed on opposite sides of the steering cuff 35 for movement of
the steerable distal end 34 of an arm 30 in a single plane. This
would be the case for laterally stabilized arms 30.
[0139] IV. Tool
[0140] As mentioned previously, the system 2 also includes at least
one tool 40. In some embodiments, the tool 40 may simply comprises
an end effector 48 positioned at the distal end of the tool arm 30
wherein the end effector 48 is operated by manipulation of
mechanisms which extend through the arm 30. In other embodiments,
each tool 40 includes a distal end 42, a proximal end 44 and an
elongate shaft 46 therebetween to allow passage through the tool
deployment lumen 38 of the arm 30. The shaft 46 is typically
desired to be a torque-stable tube comprised of any suitable
material, such as a braid or coil-reinforced extrusion. In these
embodiments, each tool 40 has an end effector 48 disposed at the
distal end 42 and optionally a handle 50 at the proximal end 44 for
manipulation of the end effector 48 from outside the body. Thus,
the tool 40 is advanced so that the end effector 48 emerges from
the distal end 34 of the arm 30.
[0141] A wide variety of end effectors 48 may be used depending on
the procedure or tissue manipulations which are desired. For
example, end effectors 48 may include but are not limited to
knives, needles, sutures, staplers, fasteners, clippers,
electrosurgical or hemostatic cutters and coagulators, laser
welders, cryosurgery instruments, secondary scopes, forceps, lasers
hooks, tongs, graspers, retractors, probes, clamps, scissors,
tissue approximation devices and suction applicators.
[0142] FIG. 29 illustrates an embodiment of a tool 40 having an end
effector 48 in the form of scissors 200. Scissors are one of the
oldest surgical instruments used by surgeons. Scissors are used to
perform many tasks in open surgical procedure but its use in
minimal access surgery requires greater skill. As shown, the
scissors 200 includes two blades 202, a fulcrum 204 and force
applicators 206. The cutting force of the scissors 200 works on the
law of lever. The force applied on the blade 202 can be calculated
by length of the force applicators 206 and force applied on the
applicators 206. The scissors 200 of the tool 40 do not apply the
exact law of lever because of the cylinder action of the long shaft
46, but the design of applicators 206 helps in the amplification of
force by lever action. When the blades 202 of the scissors 200
close, its sharp edges grind against each other and any tissue
which comes between the blades of scissors will be cut.
[0143] The scissors 200 of FIG. 29 provide an example of straight
scissors wherein the blades are straight. This is a widely used
instrument for mechanical dissection in laparoscopic surgery. Other
types of scissors include curved scissors 214, illustrated in FIG.
29A, wherein the blade 202 of the scissors 214 is slightly curved.
In some cases curved scissors 214 are preferred because the
curvature of the blade 202 of this scissors creates additional
angles of manipulation and may provide a better view through the
scope. Other types of scissors include serrated scissors 216
wherein serrated edges 218 prevent the tissue from slipping out of
the blades 202. This may be useful in cutting a slippery tissue or
ligature. Still other types of scissors include hook scissors 220
which encircle a tissue structure before cutting. Since the tissue
is held between its hooked blades, there is minimal chance of
slipping. The hook scissor 220 is especially useful for cutting
secured ducts or arteries. Likewise, the cutting of nerve bundles
in neurectomy becomes may benefit from the use of hook scissors
220. Hook scissors 220 are also helpful in partial cutting of
cystic ducts for intra-operative cholangiography. Further,
additional types of scissors include microtip scissors 222. One of
the main advantages of microtip scissors 222 is to cut ducts
partially for facilitating cannulation. Likewise, this scissor 222
may be used for cutting the cystic duct for performing
intra-operative cholangiogram. Exploration of small ducts like
common bile duct is very helpful with microtip scissors 222 due to
its fine small blades. Fine microtip scissors 222 are also
available in curved form.
[0144] FIG. 30 illustrates an embodiment of a tool 40 having an end
effector 48 in the form of gator toothed graspers 230. These
graspers 230 have reverse angled teeth 232 which are capable of
providing an aggressive grip on tissue. In addition, the graspers
230 are cupped to allow tissue to herniated when the tissue is
compressed. Thus, the graspers 230 may be useful for pelviscopy and
handling fibrous ovaries and uterine tissue.
[0145] FIG. 31 illustrates an embodiment of a tool 40 having an end
effector 48 in the form of an articulatable grasper 236. The
grasper 236 includes an articulation section 238 between grasper
jaws 240 and the shaft 46. This allows the grasper 236 to
articulate in an additional degree of freedom relative to tool arm
30.
[0146] Embodiments of the tool 40 having an end effector 48 may be
in the form of various shaped retractors. Examples of such
retractors include an angled retractor 242, (FIG. 32), hooked
retractors 244 (FIGS. 33-34), a triangular retractor 246 (FIG. 35),
and a circular retractor (FIG. 36), to name a few. Each retractor
is flexible and allows for manipulation of organs and tissue
structures.
[0147] V. Auxiliary Lumens
[0148] As mentioned previously, lumens in addition to the scope
lumen 24 and arm guide lumens 26 may be present within the main
body 10 and may be considered auxiliary lumens 58. Such lumens 58
may be used for any purpose, such as irrigation, suction,
insufflation, macerating, illuminating, grasping, or cutting to
name a few, and are typically used in conjunction with the arms 30
and/or tools 40 inserted through the arms 30 or positioned at the
ends of the arms 30.
[0149] In one embodiment, illustrated in FIG. 37A, grasping hooks
310 are inserted through a single auxiliary lumen or through
separate auxiliary lumens 58 (shown) in the shaft 20. The grasping
hooks 310 may be comprised of any suitable material, such as
shape-memory wire or shapeable polymer, that allows a hook shape to
be formed once the hooks 310 have emerged from the distal tip 16.
In addition, the hooks 310 may have a pointed or sharp tip to
assist in grasping or piercing tissue. Referring to FIG. 37B, the
grasping hooks 310 may be used to grasp a portion of tissue T to
create a plication or fold. The tool arms 30 may then be extended
on opposite sides of the folded tissue T to deploy a fixation
device 312 which will hold the plication in place. FIG. 37C
illustrates such a fixation device 312 comprising a tie 314 passing
through the tissue T with anchors 316 positioned on either side of
the plication. The tie 314 may be comprised of a suture, wire or
rod, for example, and the anchors 316 may be comprised of knots,
disks or expandable umbrellas, to name a few. Such plication
procedures may be used for treating gastroesophageal reflux disease
(GERD).
[0150] Alternatively, other tools may be passed through auxiliary
lumens 58 for similar or other purposes. For example, a corkscrew
device 320 (FIG. 38) or a grasper claw 322 (FIG. 39) may be passed
through an auxiliary lumen 58 for grasping tissue T. Or, tissue T
may be grasped with a suction device. FIG. 40A illustrates a
suction device 324 in an undeployed configuration. The suction
device 324 comprises a deployment sleeve 328 which houses an
expandable funnel 326. Withdrawal of the deployment sleeve 328
releases the funnel 326 allowing the funnel 326 to self-expand, as
shown in FIG. 40B. The increased surface area of the funnel 326
allows for adequate suction for grasping tissue T and holding the
tissue T within the funnel 326.
[0151] It may be appreciated that tools 40 may alternatively be
passed through an arm guide lumen 26 for use in conjunction with a
tool arm 30 passed through another arm guide lumen 26. For example,
as illustrated in FIG. 41, a macerator 336 may be passed through an
arm guide lumen 26 for maceration of tissue T or a blood clot while
a tool arm 30 is used for irrigation and aspiration. The macerator
336 macerates the tissue T to form small particles which may be
more readily aspirated. Further, irrigation through the arm 30 may
be used to cleanse portions of the device. For example, as
illustrated in FIG. 42, the arm 30 may be steered to face the scope
28 allowing irrigation to cleanse the scope 28 thus improving
viewing.
[0152] VI Torque Transmission
[0153] As mentioned previously, the system 2 of the present
invention includes an elongated main body 10 having a proximal end
12 and a distal end 14 terminating in a distal tip 16. An
embodiment of the main body 10 was illustrated in various
configurations in FIGS. 8A-8C utilizing steering and/or locking.
Steering and locking may be achieved by any suitable mechanisms. In
some embodiments, the shaft 20 comprises a plurality of adjacent
links, such as nestable elements 260 illustrated in FIG. 9A. FIG.
9B provided an exploded view of the nestable elements 260 of FIG.
9A, illustrating that the elements 260 are disposed so that a
distal surface 262 of one element 260 coacts with a proximal
surface 264 of an adjacent element. And, each of the nestable
elements 260 includes one or more pullwire lumens 98 through which
pullwires 96 pass. The pullwires 96 are used to hold the elements
260 in nesting alignment and to provide steering and locking.
Generally, the adjacent surfaces 262, 264 are contoured to mate so
that when the pullwires 96 are relaxed, surfaces 262, 264 can
rotate relative to one another. This allows the shaft 20 to form
curvatures throughout its length in any direction.
[0154] In addition to steering with the use of pullwires 96, the
main body 10 can be manipulated by torqueing. Typically, the distal
end 14 of the main body 10 is positioned within the body while the
proximal end 12 remains outside of the body. It is often desired to
rotate the distal end 14 within the body by manually rotating the
proximal end 12. To achieve this effectively, the main body 10
should be capable of effectively transmitting torque. To achieve
this, particularly through portions of the main body 10 which
include adjacent links, such as nestable elements 260, a torque
transmitting feature may be included.
[0155] One such torque transmitting feature is illustrated in FIGS.
43A-43F. FIGS. 43A-43F illustrate the use of a tooth and groove
concept to maintain alignment of the plurality of adjacent links at
locations along its length. By maintaining alignment in particular
locations, torque may be more easily transmitted while still
allowing freedom of rotation of the links for steering.
[0156] FIG. 43A is a perspective view of one of the plurality of
adjacent links, a first link 500. The first link 500 has a top edge
502, a bottom edge 504, an outer surface 506 and an inner surface
508 forming a domed ring-like structure having a lumen 505
therethrough. Pullwire lumens 98 are shown passing through the
inner surface 508 and out through the top edge 502. It may be
appreciated that the pullwire lumens 98 may be used for other
elements, such as support wires or rigidizing wires, however at
least some of the pullwire lumens 98 are used for passing pullwires
96 for steering. The first link 500 also includes a torque
transmitting feature comprising at least one protrusion, such as a
tooth 510, which protrudes inward from the inner surface 508 in
this embodiment. The tooth 510 may have any suitable shape or size
and may extend beyond the edges 502, 504. In this embodiment, the
tooth 510 has a first tooth end 512 and a second tooth end 514
wherein the first tooth end 512 is flush with the inner surface 508
and the second tooth end 514 protrudes outwardly toward the bottom
edge 504 of the link 500 forming a wedge shape. The torque
transmitting feature also includes at least one groove 516 in the
outer surface 506. The groove 516 is sized, shaped and positioned
so that when the first link 500 is engaged with an adjacent link,
the groove 516 in the first link 500 accepts a tooth 510 on the
adjacent link.
[0157] In some embodiments, a pair of teeth 510, 510' are present
wherein one tooth 510 is located in a diametrically opposite
position from the other tooth 510'. Likewise, a pair of grooves
516, 516' are also present wherein one groove 516 is located in a
diametrically opposite position from the other groove 516', or 180
degrees apart. Typically, the pair of teeth 510, 510' and pair of
grooves 516, 516' are located so that each are separated by
approximately 90 degrees, as shown in FIG. 43A. FIG. 43B provides a
side view and FIG. 43C provides a partial perspective view of the
link of FIG. 43A.
[0158] The first link 500 is engageable with a series or plurality
of additional links, each having the same or similar features as
the first link 500. Such a plurality of adjacent links is shown in
FIG. 43D. Here, the first link 500 is shown mated with a second
link 520, a third link 522, a fourth link 524 and a fifth link 526.
The links 500, 520, 522, 524, 526 are each individually rotateable
by steering, such as with the use of pullwires 96 as described in
related earlier sections. FIG. 43E, illustrates four of these links
500, 520, 522, 524 wherein the outer surface 506 of each link is
mated with the inner surface 508 of an adjacent link along a
longitudinal axis 530. The first link 500 is shown to have a pair
of teeth 510, 510', one tooth 510 disposed in a position along the
inner surface 508 which is diametrically opposite to the other
tooth 510'. The one tooth 510 is slidably engageable with a groove
516 in the outer surface 506 of the adjacent second link 520 and
the other tooth 510' is slidably engageable with a groove 516' in a
diametrically opposite position in the outer surface 506. In this
embodiment, groove 516 has a first groove end 518 and a second
groove end 519. The groove ends 518, 519 are substantially aligned
with the longitudinal axis 530 to allow sliding of the tooth 510
along the groove 516 during rotation of the link away from the
longitudinal axis 530. Likewise, groove 516' has a first groove end
518' and a second groove end 519' in a similar arrangement.
[0159] The second link 520 also includes a pair of teeth 510, 510'
which are each disposed 90 degrees from the grooves 516, 516'.
Therefore, only one tooth 510 is visible in the second link 520
since the teeth 510, 510' aligned in the view of FIG. 43E, however
it may be appreciated that each of the pair of teeth 510, 510' in
the second link 520 are slidably engaged with one of a pair of
grooves 516, 516' in the third link 522. Likewise, the third link
522 is shown to have a pair of teeth 510, 510', one tooth 510
disposed in a position along the inner surface 508 which is
diametrically opposite to the other tooth 510'. The one tooth 510
is slidably engageable with a groove 516 in the outer surface 506
of the adjacent fourth link 524 and the other tooth 510' is
slidably engageable with a groove 516' in a diametrically opposite
position in the outer surface 506.
[0160] Steering rotates at least some of the links away from the
longitudinal axis 530, such as illustrated in FIG. 43F. Here, the
first link 500 is shown rotated along another axis 532 which forms
an angle with the longitudinal axis 530. Such rotation slides the
one tooth 510 on the first link 500 downward along the groove 516
in the second link 520 while the other tooth 510' slides upward
along the groove 516' in the second link 520. Thus, the first link
500 is free to rotate in this plane. It may be appreciated that
each link is free to rotate in at least a plane defined by the
alignment of teeth and grooves. When the position of such aligned
teeth and grooves are varied along the length of the plurality of
adjacent links, the links are able to rotate in various
directions.
[0161] In addition, torqueing of the plurality of adjacent links is
transmitted through the aligned teeth and grooves. For example, by
applying torque to the fourth link 524, as indicated by arrow 534
in FIG. 43F, the fourth link 524 will rotate about the longitudinal
axis 530 until one of the grooves 516' contacts the slidably
engaged tooth 510' which transmits the torque to the third link
522. This transmission is repeated through each of the links,
transmitting torque to the first link 500.
[0162] Another embodiment of a torque transmitting feature is
illustrated in FIGS. 44A-44D. FIGS. 44A-44D illustrate the use of a
pin and slot concept to maintain alignment of the plurality of
adjacent links at locations along its length. By maintaining
alignment in particular locations, torque may be more easily
transmitted while still allowing freedom of rotation of the links
for steering. In addition, the pin and slot concept prevents
disengagement of the adjacent links while the main body is
unlocked. This further enhances torque transmission.
[0163] FIG. 44A is a perspective view of one of the plurality of
adjacent links, a first link 500. The first link 500 has a top edge
502, a bottom edge 504, an outer surface 506 and an inner surface
508 forming a domed ring-like structure having a lumen 505
therethrough. Although pullwire lumens are not shown, it may be
appreciated that pullwire lumens may be present, for example
passing through the inner surface and out through the top edge. It
may also be appreciated that the pullwire lumens may be used for
other elements, such as support wires or rigidizing wires, however
at least some of the pullwire lumens are used for passing pullwires
for steering. The first link 500 also includes a torque
transmitting feature comprising at least one protrusion, such as a
pin 550, which protrudes outward from the outer surface 506. The
torque transmitting feature also includes at least one slot 552,
providing an opening between the inner surface 508 and the outer
surface 506.
[0164] In some embodiments, a pair of pins 550, 550' are present
wherein one pin 550 is located in a diametrically opposite position
from the other pin 550'. Likewise, a pair of slots 552, 552' are
also present wherein one slot 552 is located in a diametrically
opposite position from the other slot 552', or approximately 180
degrees apart. Typically, the pair of pins 550, 550' and pair of
slots 552, 552' are located so that each is separated by
approximately 90 degrees as illuatrated.
[0165] FIG. 44B provides a side view of the first link 500 of FIG.
44A. Dimensions provided are related to an exemplary embodiment are
not intended to be limiting. It may be appreciated that the pin 550
may have any suitable shape or size and may be positioned anywhere
along the outer surface 506. In this embodiment, the pins 550, 550'
each have a cylindrical shape with a cross-sectional diameter of
approximately 0.0325 in. and each is positioned near the top edge
502. Each slot 552 is sized, shaped and positioned so that when the
first link 500 is engaged with an adjacent link, a slot 552 in the
first link 500 accepts a pin 550 on the adjacent link. Typically,
each slot 552 is positioned near the bottom edge 504, preferably
0.010 in. from the bottom edge 504 as illustrated in FIG. 44B. Also
illustrated in FIG. 44B, each slot 552 has a first slot end 554 and
a second slot end 556, typically approximately 0.090 in. apart. The
slot ends 554, 556 are substantially aligned with the longitudinal
axis 530 to allow sliding of the pin 550 through the slot during
rotation of the link away from the longitudinal axis 530, as will
be illustrated in FIGS. 44C-44D.
[0166] FIG. 44C illustrates the first link 500 engaged with a
second link 520 having the same or similar features as the first
link 500. The links 500, 520 are each individually rotateable by
steering, such as with the use of pullwires 96 (not shown) as
described in related earlier sections. As shown, the outer surface
506 of each link is mated with the inner surface 508 of an adjacent
link along a longitudinal axis 530. The first link 500 is shown to
have a pair of slots 552, 552', one slot 552 which is visible in
this view. Extending through the one slot 552 is a pin 550 which
protrudes from the outer surface 506 of the adjacent second link
520. It may be appreciated that the second link 520 also has an
additional pin 550' which passes through slot 552'.
[0167] Steering rotates at least some of the links away from the
longitudinal axis 530, such as illustrated in FIG. 44D. Here, the
first link 500 is shown rotated along another axis 532 which forms
an angle with the longitudinal axis 530. Such rotation slides one
pin 550 on the second link 520 upward along the slot 552 in the
first link 500 while another pin 510' slides downward along the
slot 552' in the first link 500. Thus, the second link 520 is free
to rotate in this plane. It may be appreciated that each link is
free to rotate in at least a plane defined by the alignment of pins
and slots. When the position of such aligned pins and slots are
varied along the length of the plurality of adjacent links, the
links are able to rotate in various directions.
[0168] In addition, torqueing of the plurality of adjacent links is
transmitted through the aligned pins and slots. For example, by
applying torque to the second link 520, the second link 520 will
rotate about the longitudinal axis 530 until one of the slots
contacts the slidably engaged pin which transmits the torque to the
first link 500. This transmission may be repeated through any
number of links, transmitting torque through a plurality of
adjacent links.
[0169] Another torque transmitting feature is illustrated in FIGS.
45A-45C. FIGS. 45A-45C illustrate the use of a torque transmitting
covering over the plurality of adjacent links providing torque
transmission therethrough while the links are rotateable. FIG. 45A
illustrates an embodiment of the torque transmitting covering. In
this embodiment, the covering 570 comprises a sheath 576 having
reinforcements 578 throughout. Such reinforcements 578 are
comprised of nylon, polyurethane, polyethylene, Teflon, metal,
polymer or any suitable material and are typically braided or
woven, however any arrangement of the reinforcements 578 may be
used. The reinforcements 578 may be dipped in a polymer dispersion
in a suitable solvent to coat the reinforcements 578. Such coating
holds the reinforcements 578 together in a desired arrangement
suitable for torque transmission. Alternatively or in addition, the
reinforcements 578 may be sprayed, painted or otherwise coated with
a polymer. Likewise, other methods of forming the covering 570 may
be used. It may also be appreciated that the covering 570 may be
formed without reinforcements 578. The coating may also be an
independent component that is draped over the reinforcements
578.
[0170] The covering 570 may have any suitable size or shape, but is
typically an elongate tube sized to fit snuggly around the
plurality of adjacent links which are rotateable relative to each
other when unlocked. Typically the covering 570 has a wall
thickness in the range of approximately 0.005 to 0.015 in.,
typically in the range of approximately 0.010 to 0.015 in. Snug fit
of the covering around the adjacent links prevents the links from
disengaging while allowing the links to rotate during steering.
Thus, the covering 570 may also be formed by dipping the adjacent
links in a polymer dispersion to form a coating on the links.
[0171] FIG. 45B illustrates the covering 570 fit over a series or
plurality of adjacent links (a first link 500, second link 520,
third link 522, fourth link 524 and fifth link 526) wherein the
outer surface of each link is mated with the inner surface of the
adjacent link along a longitudinal axis 530. The links 500, 520,
522, 524, 526 are each individually rotateable by steering, such as
with the use of pullwires 96 as described in related earlier
sections.
[0172] Torqueing of the plurality of adjacent links is transmitted
with the use of the covering 570. For example, by applying torque
to the fifth link 526 and surrounding covering 570, as indicated by
arrow 572 in FIG. 45C, the fifth link 526 will rotate about the
longitudinal axis 530 along with the surrounding covering 570. The
torqueing force applied to the covering 570 will be transmitted
along the length of the covering 570 from the fifth link 526 toward
the first link 500. Since the covering 570 is snuggly fit around
the links, the links will maintain engagement, assisting in the
transmission of torque. Thus, the first link 500 will then rotate
about the longitudinal axis 530, as indicated by arrow 574, in
response to the rotation of the fifth link 526.
[0173] Another torque transmitting feature is illustrated in FIGS.
46A-46E. As mentioned, embodiments of the main body typically
include a proximal end, a distal end and at least one lumen
extending between the proximal and distal ends, at least a portion
of the elongated main body comprising at least a first link and an
adjacent second link which are rotateable relative to each other
when unlocked. FIGS. 46A-46D illustrate cross-sectional views of a
link wherein one of the at least one lumen extending through the
links has at least one partition. For example, referring to FIG.
46A, a first link 500 is shown having lumen 505 extending
therethrough. The lumen 505 has two partitions 590, each partition
590 having the form of an inward protrusion. Any number of
partitions 590 may be present, such as two, three, four, five, six,
seven, eight or more. For example, FIG. 46B illustrates a first
link 500 having a lumen 505 with five partitions 590. In this
example, the partitions 590 provide the lumen 505 with a fluted
shape. The partitions 590 may have any shape, for example, blunt,
pointed, rounded, or square, and may extend inwardly any distance.
For example, FIG. 46C illustrates a first link 500 having a lumen
505 with partitions 590 which extend further into the lumen 505
than in the embodiments of FIGS. 46A-46B. Further, as illustrated
in FIG. 46D, the partitions 590 may comprise at least one divider
592 spanning across the lumen 505 of the link 500 forming
sub-lumens 594. In addition, also illustrated in FIGS. 46A-46D, the
links 500 may also include other lumens, such as steering or
pullwire lumens 98 for the passage of pullwires used in
steering.
[0174] The partitions 590 are used as a torque transmitting feature
with the use of an elongated shaft 600 passing through the lumen
505, as illustrated in FIG. 46E. As shown, the first link 500 is
engageable with a plurality of adjacent links, such as a second
link 520 and third link 522, each having the same or similar
features as the first link 500. In addition, the links 500, 520,
522 are arranged so that the partitions 590 within each link are
generally aligned. The shaft 600 passes through the lumen 505 and
is positioned between partitions 590 in each of the links.
Torqueing of the plurality of adjacent links is transmitted through
the shaft 600 and partitions 590. For example, by applying torque
to the first link 500, the link 500 rotates about the longitudinal
axis 530 until the shaft 600 contacts a partition 590. Since the
partitions 590 are generally aligned, the shaft 600 will also
contact partitions 590 in the second link 520 and third link 522.
Therefore, torque is transmitted from the first link 500 to the
third link 522. This transmission may be repeated through any
number of links, transmitting torque through a plurality of
adjacent links.
[0175] Another torque transmitting feature is illustrated in FIGS.
47A-47B. As mentioned, embodiments of the main body typically
include a proximal end, a distal end and at least one lumen
extending between the proximal and distal ends, wherein at least a
portion of the elongated main body comprises a plurality of
adjacent links. FIG. 47A illustrates a section of adjacent links,
including a first link 500, a second link 520 and a third link 522,
wherein the links have an oval cross-section. As mentioned
previously, and illustrated in FIG. 2B, the links may have an oval
shape for a variety of purposes, including providing for a desired
arrangement of, for example, a scope 28 and optionally tool arms 30
passing through lumen 505. The oval shape may also function as a
torque transmitting feature. As shown in FIG. 47B, torqueing of the
first link 500 rotates the first link 500 about the longitudinal
axis 530, as indicated by arrows 602. The first link 500 will
contact the second link 522 due to the oval shape, as shown. This
will cause the second link 522 to rotate, as indicated by arrows
604. Thus, torque is transmitted to the second link 522. This
transmission may be repeated through any number of links,
transmitting torque through a plurality of adjacent links.
[0176] Another torque transmitting feature is illustrated in FIGS.
48A-48C. As mentioned previously, embodiments of the main body
typically include a proximal end, a distal end and at least one
lumen extending between the proximal and distal ends, wherein at
least a portion of the elongated main body comprises a plurality of
adjacent links. A cross-sectional view of one of these adjacent
links, such as the first link 500, is shown in FIGS. 48A-48C,
wherein each of the links have the same or similar cross-section.
The torque transmitting feature comprises a plurality of wires or
rods 620 extending through the adjacent links. FIG. 48A shows eight
rods 620, symmetrically arranged around lumen 505. It may be
appreciated, however, that the rods 620 may be present in any
arrangement. When torque is applied to a link which is adjacent to
the first link 500, the rods 620 passing through the first link 500
transmit the torque (indicated by arrows 622) to the first link 500
thereby rotating the first link 500. This transmission may be
repeated through any number of links, transmitting torque through a
plurality of adjacent links. Similarly, FIG. 48B shows sixteen rods
620, symmetrically arrangement around lumen 505. Again, when torque
is applied to a link which is adjacent to the first link 500, the
rods 620 passing through the first link 500 transmit the torque
(indicated by arrows 622) to the first link 500 thereby rotating
the first link 500. Thus, the more rods 620 present the higher the
torque transmission. FIG. 48C shows thirty-two rods 620,
symmetrically arrangement around lumen 505. Any number of rods 620
may be present, typically ranging from eight to sixty-four. It may
also be appreciated that the rod 620 may be comprised of any
suitable material, such as metal, metal wire, polymer, nitinol,
filament or fiber, to name a few. Also, some or all of the rods 620
may be pushwires or pullwires 96.
[0177] Although the foregoing invention has been described in some
detail by way of illustration and example, for purposes of clarity
of understanding, it will be obvious that various alternatives,
modifications and equivalents may be used and the above description
should not be taken as limiting in scope of the invention which is
defined by the appended claims.
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