U.S. patent application number 13/483371 was filed with the patent office on 2012-09-20 for endoluminal surgical tool with small bend radius steering section.
This patent application is currently assigned to USGI MEDICAL, INC.. Invention is credited to Richard C. Ewers, Tracy D. Maahs, Sean Mitchell.
Application Number | 20120238952 13/483371 |
Document ID | / |
Family ID | 46829027 |
Filed Date | 2012-09-20 |
United States Patent
Application |
20120238952 |
Kind Code |
A1 |
Mitchell; Sean ; et
al. |
September 20, 2012 |
ENDOLUMINAL SURGICAL TOOL WITH SMALL BEND RADIUS STEERING
SECTION
Abstract
An endoluminal surgical instrument has first and second steering
controls on a handle. A flexible shaft attached to the handle has a
distal steerable end including a first link and a second link
separated by a plurality of intermediate links. First and second
steering elements, such as pairs of steering wires, are linked to
first and second steering controls and to the first and, second
links. One or more of the links is pivotable through an angle of at
least 30 degrees relative to an adjoining link. The set back
position of the second steering elements from the first steering
elements, and the pivoting capability of the links allows the
steerable end to be steered into a small bend radius. This makes
the instrument highly maneuverable for use in endoluminal surgery,
such as incision-less surgery of the stomach.
Inventors: |
Mitchell; Sean; (Oceanside,
CA) ; Ewers; Richard C.; (Fullerton, CA) ;
Maahs; Tracy D.; (Yorba Linda, CA) |
Assignee: |
USGI MEDICAL, INC.
San Clemente
CA
|
Family ID: |
46829027 |
Appl. No.: |
13/483371 |
Filed: |
May 30, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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12061591 |
Apr 2, 2008 |
|
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13483371 |
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Current U.S.
Class: |
604/95.04 |
Current CPC
Class: |
A61B 1/0057 20130101;
A61B 1/0052 20130101; A61B 1/0055 20130101; A61M 25/0147 20130101;
A61B 1/012 20130101; A61B 1/008 20130101 |
Class at
Publication: |
604/95.04 |
International
Class: |
A61M 25/092 20060101
A61M025/092 |
Claims
1. An endoluminal surgical instrument, comprising: a handle; first
and second steering controls on the handle; a flexible shaft
attached to the handle; the flexible shaft having a distal
steerable end including a first link and a second link separated by
a plurality of intermediate links; and first and second pairs of
steering wires attached respectively to the first and second
steering controls and the first and second links.
2. The system of claim 1 further comprising an end tip on a distal
end of the flexible shaft and with first link adjacent to the end
tip.
3. The system of claim 2 with the end tip attached onto the first
link.
4. The system of claim 1 comprising 2-10 intermediate links.
5. The system of claim 1 with the steerable end having a length L
and with the first and second links separated by a dimension equal
to 0.3 L to 0.7 L.
6. The system of claim 1 with the first pair of steering wires
angularly offset from the second pair of steering wires by 80-110
degrees.
7. The system of claim 6 with the steering wires angularly spaced
apart equally.
8. The system of claim 1 with the first, second and intermediate
links substantially the same.
9. The system of claim 1 with one or more of the links pivotal
through an angle of at least 30 degrees relative to an adjoining
pivotally attached link.
10. The system of claim 1 with one or more of the links pivotal
through an angle of at least 40 degrees relative to an adjoining
pivotally attached link.
11. The system of claim 1 with each of the links pivotal through an
angle of at least 30 degrees relative to an adjoining pivotally
attached link.
12. An endoluminal surgical instrument, comprising: a handle;
left/right and up/down steering controls on the handle; a flexible
shaft, with a proximal end of the flexible shaft attached to the
handle; the flexible shaft having a distal steerable end including
a first link and a second link separated by a plurality of
intermediate links; and left and right steering wires extending
from the left/right steering control to the first link, with the
left steering wire attached to a left side of the first link and
with the right steering wire attached to a right side of the first
link; and up and down steering wires extending from the up/down
steering control to the second link, with the up steering wire
attached to a top of the second link and with the down steering
wire attached to a bottom of the second link.
Description
PRIORITY CLAIM
[0001] This Application is a Continuation-in-Part of U.S. patent
application No. 12/061,591, filed Apr. 2, 2008, now pending and
incorporated herein by reference.
BACKGROUND
[0002] Various endoscopic systems have been successfully used to
perform a wide variety of diagnostic and surgical procedures. Most
of these types of systems having a steering capability.
Specifically, the leading or distal end of the endoscopic surgical
instrument can be introduced into the body, for example into the
stomach via the throat, with the physician then steering the tip of
instrument. The steering is typically achieved via four steering
wires attached to wheels, levers, or other actuators on the handle
of the instrument, which remains outside of the body. By
manipulating the actuators, the physician can steer the tip of the
instrument in the up/down and left/right directions. This allows
the physician to position surgical tools as desired.
[0003] In order to provide the most steering flexibility, the
distal end of the instrument advantageously can bend into a tight
radius, via control of the actuators on the handle. However, the
bending radius is limited by certain factors. One factor is that
the pivoting links that make up the skeleton or frame of the
instrument can only pivot to limited angle relative to each other.
Another factor is that the left/right and up/down steering
movements are not entirely independent. Specifically, when the
distal end of the instrument is steering to it maximum left or
right steering position, the ability to also steer in the up or
down direction becomes very limited, and vice versa. As a result,
operating the instrument to position the instrument tip as desired
can become difficult.
[0004] Accordingly, engineering challenges remain in designing
endosurgical systems allow for highly flexible positioning
options.
SUMMARY
[0005] In a first aspect, an endoluminal surgical instrument has
first and second steering controls on a handle. A flexible shaft
attached to the handle has a distal steerable end including a first
link and a second link separated by a plurality of intermediate
links. First and second steering elements, such as pairs of
steering wires, are linked to first and second steering controls
and to the first and second links. One or more of the links is
pivotable through an angle of at least 30 degrees relative to an
adjoining link. The set back position of the second steering
elements and the pivoting capability of the links allows the
steerable end to be steered into a small bend radius. This makes
the instrument highly maneuverable for use in endoluminal surgery,
such as incision-less surgery of the stomach.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] FIG. 1 is a back, top, and right side perspective view of an
endoscopic system.
[0007] FIG. 2 is a front, top, and left side perspective view of
the shapelock assembly shown in FIG. 1.
[0008] FIG. 3 is a schematically illustrated side view of the
distal end of the endoscopic system shown in FIG. 1.
[0009] FIG. 4 is an enlarged schematically illustrated side view of
the tip of the instrument shown in FIG. 3.
[0010] FIG. 5 is a schematically illustrated section views taken
along line 5-5 of FIG. 3.
[0011] FIGS. 6 and 7 are cross-sectional views of the endoscopic
system of FIGS. 1-5.
[0012] FIG. 8 is a side view of the distal end of a tight bend
radius instrument, with the sheath or outer covering removed for
purpose of illustration.
[0013] FIG. 9 is a side view of the instrument shown in FIG. 8
steered into a near maximum up position.
DETAILED DESCRIPTION OF THE DRAWINGS
[0014] Turning to the drawings, as shown in FIGS. 1 and 2, an
endoscopic system 30 includes a reusable shapelock assembly 34 that
is adapted for use within a disposable assembly generally
designated 32. The disposable assembly 32 has a flexible sheath 38
attached to a relatively rigid handle 36.
[0015] The sheath 38 includes a tip 58 attached to the distal end
of a steerable section 42. A body section 40 of the sheath 38
extends proximally from the steerable section 42 to the handle 36.
A lock nut or similar attachment holds the proximal end of the body
section 40 of the sheath 38 onto the handle 36.
[0016] Referring to FIGS. 3 and 4, the sheath tip 58 has one or
more tool lumen openings 60. A plurality of tool lumens extend
through the interior of the sheath 38. The tool lumens are defined
by one or more structural guideway members provided within the
interior of the sheath 38. In the embodiments shown, the tool
lumens are defined by a plurality of sleeves or tubes 44 and 46,
each having an open distal end that is sealed around a respective
lumen opening 60 in the tip 58. The tubes 44 and 46 extend back
from the tip 58 through the length of the sheath 38 to the handle
36. The tubes may be flexible rubber or plastic tubes that act as
guideways between the handle 36 and the tip 58 for tools and
instruments. The tubes may alternatively be flexible tubes having a
composite construction, such as a multi-layer extrusion, or coil
and/or braid reinforced construction. The tubes may be constructed
to reduce or eliminate the likelihood that the tubes will become
twisted, kinked, tangled, torn, or to prevent the lumens of the
tubes from collapsing under vacuum.
[0017] Referring still to FIGS. 3 and 4, the steerable section 42
at the distal end of the sheath 38 may be formed by segments,
links, or other generally rigid and pivotably interconnected
elements. In the example shown, the steerable section 42 includes
links, with the first link shown at 74 and the second link at 76.
The length and flexibility of the steerable section 42 is varied by
selecting the number and size of the individual links making up the
steerable section 42.
[0018] As shown in FIG. 8, a first pair of steering wires 80A or
other steering elements are attached onto opposite sides of the
first link 74 at attachment points 83. Generally the first link 74
is the front or leading link which the tip 58 attached to. A second
pair of steering wires 80B are attached to opposite sides of a
second or proximal link 75 at attachment points 81. The proximal
link 75 is spaced 4-30, 8-24 or 12-20 cm behind the first link 74,
with several intervening links 77 between the first link 74 and the
proximal link, for steering the steerable section 42. The steering
wires 80A and 80B extend back from the first link 74 and the
proximal link 75 and subsequent proximal links of the steering
section 42, through the sheath 38 to the handle 36.
[0019] Alternatively, the subsequent proximal links, i.e., links
between the handle and the proximal link 75 may be omitted and
replaced with a tubular structure not having any links. The links
are pivotally attached to each, with alternating angular positions,
i.e., with even links pivotable in the up/down direction and with
odd links pivotable in the left/right direction. The links are
designed to allow at least 30, 35, 40, 45, or more degrees of pivot
movement or angular rotation between adjoining links. The
attachment of the second steering wires 80B onto the proximal link
spaced behind the first link 74, and the pivoting capability of the
links, allows the steerable end to be steered into a small bend
radius. This makes the instrument highly maneuverable for use in
endoluminal surgery.
[0020] The steering wires may be provided within coils 82 or other
column strength element. The coils 82, if used, allow the steering
wires to be tensioned without buckling the sheath 38. The steering
section may be about 4-10 cm long, whereas the sheath 38 is
typically between 20-200 cm.
[0021] Referring to FIGS. 4 and 5, the sheath 38 has an outer skin
or layer 206 formed of a material such as a polymeric or plastic
material that is flexible and that provides a protective layer to
prevent passage ingress of bodily fluids. The cylindrical proximal
end 72 of the tip 58 is sealed onto the outer skin 206 via an
adhesive or other bonding or attachment method. The tip 58 may be
removably attached to the distal end of the sheath 38, such as by
screwing, friction fit, or other mechanism adapted to provide the
user with the ability to exchange tips for various procedures. The
tip 58 may be made of hard or soft plastic or rubber, or similar
non-porous materials. As the sleeves or tubes 44, 46 are sealed at
the lumen openings 60 of the tip 58, gases and liquids encountered
during use of the system 30 within the body are substantially
prevented from entering into the sheath 38, except through the
tubes.
[0022] As shown in FIG. 5, passageways 212 for the steering wires
may be provided within the walls Of the sheath 38. Each passageway
212 may be located within the skin material, between first and
second layers of braid or reinforcement material. The passageways
212 may be formed in straight or spiral, radially spaced alignment
extending over the length of the sheath 38.
[0023] FIG. 2 shows a locking handle 172 that opens at its distal
end. The shape lock body 150 is formed by segments, such as links
that are pivotably attached to (or positioned next to) each other
in a nested arrangement. The links may be formed as nested rings,
so that the shapelock body 150 is tubular, or has an open internal
through passageway.
[0024] Referring to FIG. 3, at position 180, the steering wires 80A
exit from the passageways 212, run inside of the steerable section
42, and attach to the first link 74 of the steerable section 42.
The other pair of steering wires 80B attach to the proximal link 75
spaced proximally apart from the first link.
[0025] Toward the proximal end of the sheath 38, the steering wires
are contained within the passageways 212 and extend to the handle
36, where the steering wires 80 are operably connected to the
control knobs 140 and 144. Consequently, the shape lock 34 may be
inserted into the central sheath opening 220 without contacting or
interfering with the steering wires.
[0026] Turning to FIGS. 6 and 7, cross-section views of the
endoscopic system 32 shown in FIG. 1. The sheath 38 may have a
composite construction, including an outer layer 322, a body member
324, and an inner layer 326. The composite construction provides
the shaft with improved strength, flexibility, and torque
transmission capability over conventional endoscopic shaft
constructions. The outer layer 322 and inner layer 326 may each
include one, two, three, or more layers of a braided or woven mesh
reinforcement material, such as polyethylene terephthalate (PET),
nylon, metal or metallic fibers, or other suitable reinforcement
material. The braided or woven mesh reinforcement layers are
preferably porous, thereby providing the ability for a bonding
material to penetrate the reinforcement layers.
[0027] FIGS. 6 and 7 also show the tubes 44 and 46, as well as two
additional tubes 48 and 50, which may optionally also be included
within the sheath 38. If used, the tubes 44 and 46 may be larger
diameter tubes having an ID of about 3 mm to about 9 mm, preferably
about 6.3 mm, with tubes 48 and 50 having a smaller diameter tubes,
with an ID of about 1.5 mm to about 7 mm, preferably about 4 mm.
The outer diameter of the sheath 38 may preferably be in the range
of about 10 mm to about 30 mm. The steering wires 80 extend from
the steering controls 140 and 144 on the handle 36 through the
sheath 38 to the distal end of the shaft at links 74 and 75. The
steering wire coils 82, if used, receive and retain the steering
wires 80. The steering wire coils 82 may be formed integrally with
or embedded in the sheath structure. Alternatively, the steering
wire coils 82, along with the tubes 44-50, may float within the
inner lumen 220.
[0028] Thus, novel methods and apparatus have been shown and
described. Various changes and substitutions may of course be made
without departing from the spirit and scope of the invention. The
invention, therefore, should not be limited except by the following
claims, and their equivalents.
* * * * *