U.S. patent application number 14/151360 was filed with the patent office on 2014-06-19 for device with deflectable distal end and related methods of use.
This patent application is currently assigned to Boston Scientific Scimed, Inc.. The applicant listed for this patent is Boston Scientific Scimed, Inc.. Invention is credited to John A. Griego.
Application Number | 20140172009 14/151360 |
Document ID | / |
Family ID | 34422461 |
Filed Date | 2014-06-19 |
United States Patent
Application |
20140172009 |
Kind Code |
A1 |
Griego; John A. |
June 19, 2014 |
Device with Deflectable Distal End and Related Methods of Use
Abstract
A deflecting method and deflecting apparatus allows the distal
end of device, for example an endoscopic medical device, to be
remotely and adjustably deflected from a straight configuration to
a deflected configuration. Manipulating a proximal handle causes
the deflection, controls actuation of an end effector assembly on
the distal end, and straightens the deflecting apparatus back to
its original configuration.
Inventors: |
Griego; John A.;
(Blackstone, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Boston Scientific Scimed, Inc. |
Maple Grove |
MN |
US |
|
|
Assignee: |
Boston Scientific Scimed,
Inc.
Maple Grove
MN
|
Family ID: |
34422461 |
Appl. No.: |
14/151360 |
Filed: |
January 9, 2014 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
10682197 |
Oct 10, 2003 |
8647362 |
|
|
14151360 |
|
|
|
|
Current U.S.
Class: |
606/205 |
Current CPC
Class: |
A61B 2017/003 20130101;
A61B 17/2909 20130101; A61B 2017/00269 20130101; A61B 2017/2947
20130101; A61B 17/29 20130101; A61B 2017/2927 20130101 |
Class at
Publication: |
606/205 |
International
Class: |
A61B 17/29 20060101
A61B017/29 |
Claims
1-78. (canceled)
79. An endoscopic device, comprising: an elongate insertion member
sized and shaped to be inserted to a target site within a living
body, the insertion member being sufficiently flexible to pass
through a natural body lumen along a tortuous path; a deflection
mechanism coupled to a distal end of the insertion member, the
deflection mechanism including proximal and distal portions
pivotally coupled to one another for movement between a
longitudinal configuration in which longitudinal axes of the
proximal and distal portions are substantially aligned with one
another and a deflected configuration in which the longitudinal
axis of the distal portion is angled with respect to the
longitudinal axis of the proximal portion, the proximal portion
including a proximal side gap extending proximally from a distal
end of the proximal portion along a portion of a length thereof and
the distal portion including a distal side gap extending distally
from a proximal end of the distal portion along a portion of a
length thereof; a first control member extending through the
insertion member to the deflection mechanism to actuate the
deflection mechanism, wherein, when the deflection mechanism is in
the longitudinal configuration, the control member extends through
the proximal and distal portions parallel to the longitudinal axes
thereof and, when the deflection mechanism is in the deflected
configuration, a portion of the control member extends out of the
proximal side gap and into the distal side gap; and an end effector
assembly extending from a distal end of the distal portion and
actuated a second control member.
80. The device of claim 79, wherein the first control member is a
wire coupled to a distal end of the distal portion.
81. The device of claim 79, wherein the end effector assembly
includes a grasper.
82. The device of claim 79, wherein the first control member
electrically couples the end effector to a proximal end of the
insertion member which remains accessible to a user when the end
effector is inserted into a body.
83. The device of claim 79, further comprising a handle coupled to
a proximal end of the insertion member so that the handle remains
accessible to a user when the end effector is inserted into a
body.
84. The device of claim 83, further comprising a deflection
actuator movable relative to the handle, the deflection actuator
being coupled to the first control member so that movement of the
deflection actuator relative to the handle moves the first control
member relative to the insertion member to move the deflection
mechanism between the longitudinal and deflected
configurations.
85. The device of claim 84, wherein the deflection actuator is
slidable over a central shaft of the handle.
86. The device of claim 79, wherein the deflector member is
connected to the connector via one of a weld, an adhesive, a free
pivot pin, a ball and socket, and a clevis.
87. The device of claim 79, wherein the handle further comprises an
end effector actuator coupled to the second control member.
88. A method for treating tissue, comprising: inserting an end
effector through a naturally occurring body lumen along a tortuous
path to a target site within a living body, the end effector being
coupled to a deflection mechanism, the deflection mechanism
including a proximal portion coupled to the distal end of the
insertion member and a distal portion pivotally coupled to the
proximal portion; moving a first control member relative to the
insertion member to deflect the distal portion of the deflection
mechanism relative to the proximal portion to aim the end effector;
and moving a second control member relative to the insertion member
to actuate the end effector wherein, when in the deflected
configuration, the first control member extends out of the
deflection mechanism via side gaps in the proximal and distal
portions.
89. The method of claim 88, wherein actuating the end effector
includes a grasper.
90. The method of claim 88, further comprising applying a current
to the end effector via one of the first and second control
members.
91. The method of claim 88, wherein a proximal end of the insertion
member coupled to a handle including a central shaft.
92. The method of claim 91, wherein the handle includes a
deflection actuator coupled to the first control member, further
comprising sliding the deflection actuator relative to the central
shaft of the handle to actuate the deflection mechanism.
93. The method of claim 91, wherein the handle includes an end
effector actuator coupled to the second control member for
actuating the end effector.
94. A deflection mechanism for an end effector assembly coupled to
a flexible insertion member, comprising: a proximal portion
defining a first lumen extending therethrough, the proximal portion
including a proximal end gap extending proximally from a distal end
of the proximal portion along a portion of a length thereof; a
distal portion a proximal end of which is pivotally coupled to a
distal end of the proximal portion, the distal portion defining a
second lumen extending therethrough and including a distal end gap
extending distally from the proximal end of the distal portion
along portion of a length thereof, wherein the proximal and distal
portions are movable relative to one another between a longitudinal
configuration in which the first and second longitudinal axes are
substantially aligned and a deflected configuration in which the
first and second longitudinal axes are angled with respect to one
another; and a control member extending through the proximal and
distal portions and coupled to a distal end of the distal portion
such that the deflector member extends along the first and second
longitudinal axes in the longitudinal configuration and passes out
of the proximal and distal portions through the proximal and distal
end gaps in the deflected configuration.
Description
DESCRIPTION OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The invention relates to a device having a deflectable
distal end and methods of using such a device. More specifically,
the invention relates to a device having a distal end that remotely
and adjustably deflects from a straight configuration to a
configuration that is at least up to 90 degrees from the straight
configuration. The device may be, for example, a medical device,
such as an endoscopic medical device.
[0003] 2. Background of the Invention
[0004] Lesions or other undesirable tissue may form in internal
organs or other tissue tracts within the body. Such undesirable
tissue may simply irritate the surrounding tissue or, in a more
serious case, may be cancerous and if not quickly removed cause
deterioration of the surrounding tissue and subsequent failure of
the organ or tissue tract.
[0005] One method of removing the undesirable tissue is through a
conventional open surgical procedure during which the undesirable
tissue is cut away. Such an open surgical procedure, however, is
highly invasive, expensive, relatively traumatic to the patient,
and would be inappropriate for many situations where only a small
amount of tissue, for example, a small lesion, needs to be
removed.
[0006] A procedure that may used to remove the undesirable tissue
when an open surgical procedure is impractical is full thickness
resection. In that procedure, a full thickness resection device
(FTRD) is advanced endoluminally to the desired portion of the
body, for example through a working channel of an endoscope, and
positioned near the undesirable tissue. A grasping device, such as
an endoscopic grasper having a pair of jaws at a distal end, grabs
the undesirable tissue and brings the undesirable tissue into an
open distal portion of the FTRD. The FTRD then resects the
undesirable tissue and connects the surrounding tissue together to
close the hole created by the resection. The FTRD containing the
undesirable tissue then is advanced out of the body. An example of
an FTRD and related method of use is disclosed in U.S. Pat. No.
6,398,795 to McAlister et al., the full disclosure of which is
hereby incorporated by reference.
[0007] A problem with current FTRDs, however, is in the positioning
of the grasping device, and particularly the grasper jaws located
at the distal end of the device. The jaws need to be maneuvered to
the tissue to be resected. While the positioning of the grasper
jaws may be assisted by the presence of a preformed bend in an
elongate, tubular member leading up to the grasper jaws, it still
may be difficult to position the grasper jaws so that they grasp
the tissue to be resected. This difficulty in positioning may
result in procedures that are more complex and longer than
necessary, and may cause undesired removal of surrounding healthy
tissue.
[0008] It is accordingly an object of the invention to have a
device with a deflectable distal end, for example a grasping device
with a deflectable distal end so that grasper jaws can be remotely
and adjustably deflected from a longitudinal axis of the device,
for easier, faster, and more precise positioning of the grasper
jaws.
SUMMARY OF THE INVENTION
[0009] In accordance with the invention, an embodiment of the
invention includes an end effector apparatus having a deflecting
mechanism having a proximal portion, a distal portion, and a
redirection mechanism between the proximal portion and the distal
portion, the redirection mechanism configured to allow the distal
portion to be redirected relative to the proximal portion. The end
effector apparatus also has an end effector assembly coupled to the
distal portion and a first actuator coupled to the deflecting
mechanism to redirect the distal portion with respect to the
proximal portion via the redirection mechanism.
[0010] In accordance with another aspect of the invention, an
embodiment of the invention includes an endoscopic medical device
having an end effector assembly, a deflecting mechanism coupled to
the end effector assembly, the deflecting mechanism including a
proximal portion, a distal portion, and a pivot portion connecting
the proximal portion to the distal portion, the pivot portion
configured to allow the distal portion to deflect relative to the
proximal portion, and a handle. The endoscopic medical device also
has an elongate member connecting the handle to the deflecting
mechanism, an actuator wire extending through the elongate member
and connecting the handle to the end effector assembly, and a
deflector wire extending through the elongate member and connecting
the handle to the deflecting mechanism. The handle of the
endoscopic medical device is configured to control the end effector
assembly via the actuator wire and the deflecting mechanism via the
deflector wire.
[0011] In accordance with yet another aspect of the invention, an
embodiment of the invention includes a method of performing a
procedure with an end effector apparatus by providing a distal end
effector assembly coupled to an elongate member in a substantially
straight configuration, redirecting the distal end effector
assembly such that the distal end effector assembly and the
elongate member are no longer in a substantially straight
configuration, and actuating the distal end effector assembly to
perform the procedure.
[0012] In accordance with yet another aspect of the invention, an
embodiment of the invention includes an endoscopic medical
procedure that is performed by providing an endoscopic medical
device having an elongate member with a redirecting mechanism and
an end effector assembly at a distal end of the elongate member,
with the redirecting mechanism in a substantially straight
configuration, advancing the elongate member into a body lumen
until the distal end is proximate a treatment site, and redirecting
the redirecting mechanism such that the redirecting mechanism is no
longer in the substantially straight configuration to position the
end effector assembly toward the treatment site. The endoscopic
medical procedure is also performed by actuating the end effector
assembly to perform a medical procedure and returning the
redirecting mechanism to the substantially straight
configuration.
[0013] Additional objects and advantages of the invention will be
set forth in part in the description which follows, and in part
will be obvious from the description, or may be learned by practice
of the invention. The objects and advantages of the invention will
be realized and attained by means of the elements and combinations
particularly pointed out in the appended claims.
[0014] It is to be understood that both the foregoing general
description and the following detailed description are exemplary
and explanatory only and are not restrictive of the invention, as
claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The accompanying drawings, which are incorporated in and
constitute a part of this specification, illustrate embodiments of
the invention and together with the description, serve to explain
the principles of the invention.
[0016] FIG. 1a is perspective view of a deflecting mechanism,
according to an embodiment of the present invention.
[0017] FIG. 1b is a side view of the deflecting mechanism of FIG.
1a.
[0018] FIG. 1c is a side view of an end effector assembly connected
to the deflecting mechanism of FIG. 1a.
[0019] FIG. 2a is a perspective view of a proximal portion of the
deflecting mechanism of FIG. 1a.
[0020] FIG. 2b is a side view of the proximal portion of FIG.
2a.
[0021] FIG. 2c is a top view of the proximal portion of FIG.
2a.
[0022] FIG. 2d is a cross-sectional view along line II-II of FIG.
2c.
[0023] FIG. 3a is a perspective view of a distal portion of the
deflecting mechanism of FIG. 1a.
[0024] FIG. 3b is a side view of the distal portion of FIG. 3a.
[0025] FIG. 3c is a top view of the distal portion of FIG. 3a.
[0026] FIG. 3d is a cross-sectional view along line of FIG. 3c.
[0027] FIG. 4 is a schematic view of a pivot portion of the
deflecting mechanism of FIG. 1a.
[0028] FIG. 5 is a schematic view of a medical device, showing the
proximal handle portion connected to the deflecting mechanism of
FIG. 1a, an elongate shaft, and end effectors.
DESCRIPTION OF THE EMBODIMENTS
[0029] Reference will now be made in detail to the present
exemplary embodiments of the invention illustrated in the
accompanying drawings. Wherever possible, the same reference
numbers will be used throughout the drawings to refer to the same
or like parts.
[0030] In the various embodiments, the invention pertains to a
mechanism for deflecting a distal end of a device. The device may
include a proximal handle, a distal end effector assembly (such as
grasper jaws), and an elongate member connecting the handle to the
end effector assembly. A deflecting mechanism may be included along
the elongate member, for example at the end of the elongate member
proximate the end effector assembly. In the embodiments, a user may
manipulate a portion of a handle that controls the deflecting
mechanism. The manipulation may cause the deflecting mechanism,
which was in a straight configuration, to bend. Depending on the
amount of manipulation, the bending of the deflecting mechanism
causes the distal portion of the device to assume an up to at least
90 degrees angle relative to an axis of the elongate member. Once a
desired bend and angle is attained, the user may position the end
effector assembly proximate to a desired position to perform an
operation. The user then may manipulate another portion of the
handle, causing the end effector assembly on the distal end of the
device to actuate, the amount of actuation dependent on the amount
of manipulation of the handle. Actuation of the end effector
assembly performs the desired operation, such as grasping of
tissue. If desired, at this point in the procedure or later, so
that the device may be removed from a body in the case of a medical
device, the user may once again manipulate the portion of the
handle that controls the deflecting mechanism, causing the
deflecting mechanism to straighten back to substantially its
original configuration.
[0031] FIG. 5 shows an exemplary embodiment of a device 1 including
a deflecting mechanism 10. Device 1 is an endoscopic medical device
and, more particularly, an endoscopic grasper. As will be explained
below, however, any other type of device that requires deflecting a
distal end may include a deflecting mechanism according to this
invention.
[0032] As its main components, device 1 includes deflecting
mechanism 10, an end effector assembly 300, a handle portion 400,
an elongate member 200 connecting handle portion 400 to end
effector assembly 300, and a deflector wire 150 an actuator wire
160 that actuate deflecting mechanism 10 and end effector assembly
300, respectively.
[0033] As shown in the Figures, deflecting mechanism 10 has a
proximal end 12 and a distal end 11. The deflecting mechanism
includes a proximal portion 110, a distal portion 130, and a pivot
portion 170. FIGS. 1a-1b and 2a-2d depict an exemplary embodiment
of proximal portion 110. Proximal portion 110 may have a generally
circular cross-sectional shape or any other suitable shape
permitting connection to other parts of device 1 and advancement
through an endoscope working channel, an FTRD, or a tissue tract.
Proximal portion 110 includes an interface 111 on its proximal end
121 configured to connect with elongate member 200. The interface
111 may be circular in shape and define a proximal opening 118
leading to a wire shaft 116 inside portion 110. Both proximal
opening 118 and wire shaft 116 may receive and allow longitudinal
movement of wires, for example, deflector wire 150 and actuator
wire 160. Moving toward its distal end 122, proximal portion 110
includes a wire gap wall 117 on one side, a wire containing wall
115 on an opposite side, and sidewalls 123 connecting the wire gap
wall 117 to the wire containing wall 115.
[0034] The wire gap wall 117 may have the shortest length of the
walls, leaving a wire gap 114. Wire gap 114 allows movement of
wires between the sidewalls 123 during deflection of the deflecting
mechanism 10. The edge of wire gap wall 117 proximate wire gap 114
may be configured and/or composed of material to reduce friction
and resist pressure exerted on it by at least one wire that may
press against it during deflection and/or actuation. The edge of
wire gap wall 117 proximate the wire gap 114 may also be configured
and/or composed of a material to resist wearing away from the
longitudinal movement of the deflector wire 150 and actuator wire
160 along the edge. The wire containing wall 115 is longer than the
wire gap wall 117 and shorter than the sidewalls 123. Proximal
portion 110 defines a distal portion receiving area 120 at its
distal end 122.
[0035] In the embodiment shown, sidewalls 123 are the longest
portions of proximal portion 110 and may each have near distal end
122 a pivot interface 112 configured to assist the connection of
proximal portion 110 to distal portion 130. The portions of
sidewalls 123 next to wire gap 114 may be configured and/or
composed like the edges of the wire gap walls 117 next to the wire
gap 114, as set forth above. Pivot interfaces 112 of sidewalls 123
may be holes that are generally circular in shape and axially
aligned with each other. Pivot interfaces 112 receive and retain
pivot couplings 171, as will be described below, and allow rotation
of pivot couplings 171 within them. Between the pivot interfaces
112 of sidewalls 123 may be distal gap 119 to accept, among other
things, a portion of distal portion 130. The distal ends of
sidewalls 123, and particularly the external surfaces of sidewalls
123, may be rounded and/or otherwise configured (for example,
composed of certain materials) so as to minimize irritation and/or
damage to tissue that it may come into contact with.
[0036] FIGS. 1a-1b and 3a-3d depict an exemplary embodiment of
distal portion 130 of deflecting mechanism 10. The distal portion
130 includes an end effector assembly interface 131 on its distal
end 142 configured to connect with end effector assembly 300. The
end effector assembly interface 131 generally may be circular in
shape and define a distal opening 138 leading to a wire shaft 136.
Distal opening 138 and wire shaft 136 receive and allow
longitudinal movement of wires, for example, deflector wire 150 and
actuator wire 160. Distal opening 138 communicates with a portion
of end effector assembly 300.
[0037] Distal portion 130 also includes a wire gap wall 137 on one
side, a wire containing wall 135 on the opposite side, and
sidewalls 144 connecting wire gap wall 137 to wire containing wall
135. Wire gap wall 137 is the shortest of these walls, leaving a
wire gap 134 that allows movement of wires between the sidewalls
144 during deflection. The edge of the wire gap wall 137 proximate
the wire gap 134 may be configured and/or composed of material to
reduce friction and resist pressure exerted on it by at least one
wire pressed up against during deflection and/or actuation. The
edge of the wire gap wall 137 proximate the wire gap 134 may also
be configured and/or composed of material to resist wearing away
from the longitudinal movement, for example, of the deflector 150
and actuator wire 160 along the edge. The wire containing wall 135
is longer than the wire gap wall 137 and shorter than the sidewalls
144. Wire containing wall 135 may also have a gap starting from
proximal end 143 and narrowing until it reaches approximately the
mid-section of the distal portion 130 and/or sidewalls 144.
[0038] In another exemplary embodiment, the sidewalls 144 are the
longest portions of the distal portion 130 and may each have near
proximal end 143 a pivot interface 132 configured to assist
connection of the distal portion 130 to the proximal portion 110.
The portions of the sidewalls 144 next to the wire gap 134 may be
configured and/or composed like the edges of the wire gap walls 137
next to the wire gap 134 as set forth above. Pivot interfaces 132
of sidewalls 144 may be holes that are generally circular in shape
and axially aligned with each other. Pivot interfaces 132 receive
and retain pivot couplings 171, as will be describe below, and
allow the free rotation of pivot couplings 171 within them. Between
the pivot interfaces 132 of sidewalls 144 may be proximal gap 139
to accept, among other things, portions of deflector wire 150 and
actuator wire 160. Between the sidewalls 144 may also be wire
receiving gap 140, wire gap 134, and/or wire shaft 136. Disposed
around proximal end 143 of distal portion 130 may be proximal
portion insertion zone 145 configured to be inserted into distal
gap 119 between the distal ends 122 of sidewalls 123 of proximal
portion 110. The proximal ends of sidewalls 144, for example
external surfaces of sidewalls 144 opposite wire shaft 136, may be
rounded and or otherwise configured (for example, composed of
certain materials) so as to minimize irritation and/or damage to
tissue that it may come into contact with.
[0039] Near end effector assembly interface 131, distal portion 130
includes a deflector wire connector 141. Connector 141 may be
disposed on a portion of the wire gap wall 137 near distal opening
138. Deflector wire 150 may connect to connector 141, for example,
by welding or more specifically laser welding. Any other method of
connecting deflector wire 150 to connector 141 or any other portion
of distal portion 130, for example, using adhesives or any other
type of joining material/components, is also acceptable. Other
methods of connecting the deflector wire 150 to the connector 141
include a free pivot pin, a ball and socket, or a clevis. Deflector
wire 150 may be fixed to connector 141 or movably connected to, for
example, allow deflector wire 150 to shift and/or rotate with
respect to connector 141 while still maintaining a connection.
Deflector wire 150 may be joined to connector 141 such that the
deflector wire 150 is not parallel to the longitudinal axis of the
distal portion 130. For example, deflector wire 150 may be angled
so that it is joined to connector 141 at its distal end, and then
proceeds toward the wire gap 134 and/or proximal gap 139 of distal
portion 130. This orientation may assist the deflecting of the
deflecting mechanism 10, a process which will be described in
further detail below.
[0040] FIGS. 1a-1b and 4 depict an exemplary embodiment of the
pivot portion 170 of deflecting mechanism 10. Pivot portion 170
joins the proximal portion 110 with the distal portion 130.
Specifically, the pivot interface 112 of the proximal portion 110
may be connected to the pivot interface 132 of distal portion 130
by pivot couplings 171. The pivot couplings 171 may be comprised of
a stainless steel mandel, and more specifically a U-shaped through
mandrel to allow room for the wires. Insertion of pivot couplings
171 through pivot interfaces 112 and 132 connects proximal portion
110 and distal portion 130. The pivot interfaces 112, 132 retain
the pivot couplings 171. For example, the pivot couplings 171, once
inserted through both pivot interfaces 112, 132, may be deformed,
for example, at the insertion ends 173 so that the pivot couplings
171 can no longer be removed from the pivot interfaces 112, 132. In
another example, the pivot interface 112 of the proximal portion
110 may have a recess 174 configured to accept and retain the
recess interface 172 of the pivot coupling 171. An adhesive may be
placed in the pivot recess 174 prior to inserting the insertion end
173 of the pivot coupling 171 through the pivot interface 112 of
the proximal portion 110, thus allowing the adhesive to join the
recess interface 172 with the pivot recess 174 when the recess
interface 172 is inserted. The epoxy adhesive, however, may also be
placed on the pivot interface 132 of the distal portion. In yet
another example, the pivot coupling may be welded, or more
specifically laser welded, to either of the distal or proximal
portions. The recess interface 172 may be configured so that it is
flush with the external portion of the sidewall 123 of the proximal
portion 110, for example, to minimize sharp edges and/or
protrusions that may irritate and/or damage tissue when it enters
and/or is advanced in a tissue tract or internal organ or catch
onto a working channel of an endoscope.
[0041] The pivot portion 170 permits the proximal portion 110 and
distal portion 130 to rotate with respect to each other around an
axis formed by the central axes of the pivot couplings 171 and/or
the pivot interfaces 112, 132. For example, the pivot couplings 171
may be rotatably fixed with respect to the proximal portion 110,
allowing the distal portion 130 to rotate with respect to the pivot
couplings 171, or the pivot couplings 171 may be rotatably fixed
with respect to the distal portion 130, allowing the proximal
portion 110 to rotate with respect to the pivot couplings 171. In
another example, both the proximal portion 110 and the distal
portion 130 may be rotatable with respect to the pivot couplings
171.
[0042] The arrangement of the proximal portion 110, distal portion
130, and pivot portion 170 allows deflecting mechanism 10 to bend
in one direction and return to its initial straight configuration.
In the embodiment shown, the wire containing walls 115, 135 are on
the same side and the wire gaps 114, 134 and wire gap walls 117,
137 are on the other side. Accordingly, the deflecting mechanism 10
may bend such that the external portions of the wire gap walls 117,
137 rotate towards each other, and that the external portions of
the wire containing walls 115, 135 rotate away from each other.
Once bent in that direction, the arrangement of the proximal
portion 110, distal portion 130, and pivot portion 170 would then
permit the deflecting mechanism 10 to bend or pivot back such that
it returns to its original straight configuration. However, once
back in this original straight configuration, or even in its
initial straight configuration the arrangement of the proximal
portion 110, distal portion 130, and pivot portion 170 may prevent
the proximal portion 110 and distal portion 130 from further
rotating such that the external portions of the wire gap walls 117,
137 rotate away from each other, and that the external portions of
the wire containing walls 115, 135 rotate towards each other. For
example, the wire containing walls 115, 135 may be configured such
that in a straight configuration, the external portion of the wire
containing wall 135 contacts the internal portion of wire
containing wall 115, thus preventing bending and/or pivoting of the
deflecting mechanism such that the wire containing walls 115, 135
rotate towards each other when in a straight configuration.
[0043] The arrangement of the pivot portion 170, proximal portion
110, and distal portion 130 permit bending of the deflecting
mechanism 10 such that the central longitudinal axes of the
proximal portion 110 and the distal portion 130, as measured
extending from the pivot portion 170, go from forming a straight
180 degree angle to forming down to at least a 90 degree angle. The
deflecting mechanism 10 may be configured to bend such that the
central longitudinal axes of the proximal portion 110 and the
distal portion 130 form less than a 90 degree angle, for example,
so that a portion of sidewall 144 of the distal portion 130 enters
the wire gap 114 of the proximal portion 110 and/or the wire gap
walls 117, 137 almost come into contact with each other.
[0044] FIGS. 1a-1b and 5 depict an exemplary embodiment of elongate
member 200 of the device 1. Elongate member 200 essentially
comprises a hollow tube to connect the handle 400 to the deflecting
mechanism 10. In the case of an endoscopic device, elongate member
200 would have a length and flexibility to extend from a point
outside the body and through a tortuous body lumen proximate to an
operation site.
[0045] Member 200 has a body 201 which comprises, for example, a
stainless steel coil covered with a nylon sheath. The coil allows
flexibility as the member 200 winds its way through tortuous
anatomy and also prevents crushing, for example of member 200, from
occurring when tension is applied to the actuator or deflector
wires 150, 160 via the handle 400. However, other material
compositions and configurations, for example a metal tube with a
rubber or plastic covering, are also contemplated. Body 201 may
have on one end a deflector interface 202 configured to connect,
for example, with the connector interface 111 on the proximal end
121 of the proximal portion 110. A central hollow portion of
deflector interface 202 communicates on one side with a central
hollow portion of body 201, and on the other side with the proximal
opening 118 of the connector interface 111. The central hollow
portion of the deflector interface 202 and/or the central hollow
portion of the body 201 is configured to receive and allow the
longitudinal movement of wires, for example, deflector wire 150 and
actuator wire 160.
[0046] Elongate member 200 may also have on its proximal end a
handle interface 203. The handle interface 203 connects to an
interface 403 on a distal end 401 of the handle portion 400. The
central hollow portion of the handle interface 203 communicates
with the central hollow portion of the body 201 and a central
hollow portion of a central shaft 404 of the handle 400, to allow
the longitudinal movement of wires, for example, deflector wire 150
and actuator wire 160. In another example, the elongate member 200
and proximal portion 110 of the deflecting mechanism 10 may be one
continuous piece of material.
[0047] FIGS. 1a-1c and 5 depict an exemplary embodiment of end
effector assembly 300 of the device 1. The end effector assembly
300 may be any type of medical or non-medical end effector assembly
which may require deflecting. The end effector assembly 300 may
have an end effector assembly body 301 which comprises, for
example, an actuatable grasper 303. The grasper 303 may have
opposing jaw portions configured to grasp and/or cut tissue. The
end effector assembly body 301 may have on one end a deflector
interface 302 configured to connect, for example, with the end
effector assembly interface 131 on the distal end 142 of the distal
portion 130. A central hollow portion of the deflector interface
302 communicates on one side with a central hollow portion of the
end effector assembly body 301, and on the other side with the
distal opening 138 of the end effector assembly interface 131. The
central hollow portion of the deflector interface 302 and/or the
central hollow portion of the end effector assembly body 301 may be
configured to receive and allow the longitudinal movement of wires,
for example, at least actuator wire 160. The actuator wire 160 may
be connected to the grasper jaws 303, for example, so that
longitudinal movement of the actuator wire 160 with respect to the
end effector assembly body 301 and/or the deflector interface 302
may cause the grasper jaws 303 to open and close. In another
example, the end effector assembly 300 and the distal portion 130
may be one continuous piece of material.
[0048] Any end effector assembly, including any suitable end
effectors and arrangement for actuating the end effectors, may be
used with deflecting mechanisms according to this invention. As
shown in the exemplary embodiment depicted in FIG. 5, end effector
assembly 300 includes a bar linkage 304 connected at a proximal end
to the distal end of actuator wire 160 and at a distal end to
portions of grasper jaws 303. Bar linkage 304 may include,
corresponding to each grasper jaw, a proximal link connected to a
distal link. The proximal ends of the grasper jaws 303 connect to
the distal ends of the proximal links, and the proximal ends of the
proximal links connect together, pivot about each other, and
connect to the actuator wire 160. Distal movement of the actuator
wire 160 may cause the links to move and the grasper jaws 303 to
open (i.e. the distal ends of the grasper jaws 303 to move away
from each other). Proximal movement of the actuator wire 160 may
cause the bar linkages 304 to move and the grasper jaws 303 to
close (i.e. the distal ends of the grasper jaws 303 to move towards
each other).
[0049] FIG. 5 depicts an exemplary embodiment of handle portion 400
of the device 1. Handle portion 400 is generally configured to be
easily grasped and/or handled by the user. Handle portion 400 may
have an interface 403 on distal end 401. Interface 403 may be
configured to connect with handle interface 203 of elongate member
200. Interface 403 may be hollow and communicate with the central
hollow portion of the elongate member 200. Interface 403 may expand
from having a smaller cross-sectional area at its distal end to a
larger cross-sectional area at its proximal end. At its proximal
end, interface 403 connects to central shaft 404 of handle portion
400. Central shaft 404 may have a substantially constant
cross-sectional area along its entire length and may be made of a
material that facilitates sliding of, for example, actuation handle
405 and deflection handle 409 along its length. Actuation handle
405 and deflection handle 409 may be in the form of a spool, or may
be in any other suitable configuration to move actuator wire 160
and deflector wire 150, respectively. Central shaft 404 may be one
continuous piece or multiple pieces, for example, a central shaft
actuation portion 412 and a central shaft deflection portion 413,
joined by the central stop 408 and/or multiple central stops.
[0050] As shown in the exemplary embodiment of FIG. 5, central
shaft 404 has various parts of handle 400 disposed around it. The
various parts may be coaxial with the central shaft 404. For
example, an actuation handle is disposed near distal end 401 of
handle portion 400. Actuation handle 405 may be coaxial with and
disposed around central shaft 404, or at least central shaft
actuation portion 412 of central shaft 404. Actuation handle 405 is
slidable along central shaft actuation portion 412 of central shaft
404, for example, between the distal end of central stop 408 and
the proximal end of connector interface 403.
[0051] Inside of actuation handle 405 is actuator wire interface
portion 407 which connects actuator wire 160 to actuation handle
405. Any suitable method of attaching actuator wire 160 to
actuation handle 405 is acceptable, for example, adhesives or set
screws. For example, one or more set screws may extend through
actuator wire interface portion 407 on actuation handle 405 to lock
actuator wire 160 in place with respect to actuation handle 405.
Actuation handle 405 also includes a recessed actuation grasping
portion 406 disposed between the proximal and distal ends of
actuation handle 405 to allow the user to better grasp and move
actuation handle 405 with respect to central shaft 404.
[0052] A deflection handle 409 is disposed near the central and/or
proximal portion of handle 400. Deflection handle 409 may be
coaxial with and disposed around central shaft 404, or at least
central shaft deflection portion 413 of central shaft 404.
Deflection handle 409 slides along central shaft deflection portion
413 of central shaft 404, for example, between the proximal end of
central stop 408 and the distal end of proximal stop 414 on
proximal end 402. Inside of deflection handle 409 is a deflector
wire interface portion 411 which connects deflector wire 150 to
deflection handle 409. Any suitable method of attaching the
deflector wire 150 to the deflection handle 409 is acceptable, for
example, adhesives or set screws. For example, a set screw may
extend through deflector wire interface portion 411 on deflection
handle 409 to lock deflector wire 150 in place with respect to
deflection handle 409. Deflection handle 409 also has a recessed
deflection grasping portion 410 disposed between the proximal and
distal ends of deflection handle 409 to allow the user to better
grasp and move deflection handle 409 with respect to central shaft
404.
[0053] The proximal end 402 of handle portion 400 includes proximal
stop 414. Proximal stop 414 may be disposed around central shaft
404 or may be configured to receive and connect with central shaft
404. Both central stop 408 and proximal stop 414 may be easy to
grasp. For example, their size, weight, composition, and/or texture
may vary depending on various handling requirements. In an example,
handle portion 400 may be made of molded plastic. Central stop 408
and proximal stop 414 may be configured to be fixed relative to
central shaft 404, however, they may also be movable, for example,
to adjust the length of central shaft deflection portion 413 and/or
central shaft actuation portion 412. Adjusting the length of
central shaft portions 412, 413 will limit or extend the movement
of actuation handle 405 and deflection handle 409, respectively,
proximally and/or distally along central shaft 404, thereby
altering the amount of actuation of the end effectors (degree of
opening of grasper jaws, for example) and deflection of the
deflecting mechanism.
[0054] Deflector wire 150 connects to a portion of handle portion
400 and extends through central shaft 404 of handle portion 400 and
into body 201 of elongate member 200. More specifically, deflector
wire 150 connects to the deflector wire interface portion 411 of
the deflection handle 409. Deflector wire 150 enters proximal end
121 of proximal portion 110 of deflecting mechanism 10, through
proximal opening 118. Once through proximal opening 118, deflector
wire 150 extends within wire shaft 116 between wire gap wall 117,
sidewalls 123, and wire containing wall 115. Moving distally in
proximal portion 110, deflector wire 150 extends past the distal
end of wire containing wall 115 into distal gap 119 between pivot
interfaces 112,132 and between ends 173 of pivot couplings 171. As
depicted in FIG. 5, a portion of deflector wire 150 at least in the
vicinity of pivot portion 170 may be located slightly towards the
wire gaps 114,134.
[0055] Deflector wire 150 extends into proximal end 143 of distal
portion 130 of deflecting mechanism 10 between sidewalls 144 and
wire gap 134 and into wire shaft 136. Upon reaching distal end 142
of distal portion 130, deflector wire 150 connects to deflector
wire connector 141 located at distal end 142 of wire gap wall 137,
as set forth above.
[0056] Actuator wire 160 may be disposed within and with respect to
deflecting mechanism 10 and other components of the device 1 in a
manner similar to deflector wire 150 as set forth above. Generally,
actuator wire 160 extends substantially parallel to deflector wire
150 for the vast majority of their lengths, and thus may be
positioned and configured similarly to deflector wire 150 as set
forth above. Some differences in position and connection exist,
which will be described. For example, the position of connection of
actuator wire 160 to handle portion 400 may differ. Actuator wire
160 connects to actuator wire interface portion 407 of actuation
handle 405. The actuator wire interface portion 407 connects
actuator wire 160 to actuation handle 405 by screws, adhesives, or
any other suitable method known in the art. Actuator wire 160 then
extends distally through a central hollow portion of central shaft
404 and into interfaces 403, 203. From there, actuator wire 160
extends through elongate member 200 and into the proximal end of
deflector interface 202. Once actuator wire 160 is in distal end
142 of distal portion 130 and in wire shaft 136, it exits distal
portion 130 (and hence deflecting mechanism 10) through distal
opening 138.
[0057] Actuator wire 160 then connects to end effector assembly
300. Actuator wire 160 enters and extends through interface 302 of
end effector assembly 300, into the proximal end of end effector
assembly body 301, and through at least a portion of body 301 until
it connects to end effector assembly 300. In the embodiment,
actuator wire 160 connects to a proximal end of bar linkages 304,
as shown in FIG. 5. Longitudinal movement of actuator wire 160 with
respect to handle portion 400, elongate member 200, deflecting
mechanism 10, and end effector assembly 300 causes grasper jaws 303
to open and close.
[0058] Wires 150 and 160 may be comprised of any suitable flexible
material and may be any suitable cross-sectional size for fitting
within an endoscopic medical device. In addition, actuator wires
150 and 160 may have different sizes and/or be made of different
materials.
[0059] Deflecting mechanism 10 also may be made of any suitable
biocompatible material, such as metal, plastic, rubber, or other
synthetic or natural materials. In other embodiments of deflecting
mechanism 10, proximal portion 110 and distal portion 130 may have
non-circular cross-sections, such as oval or hexagonal, deflecting
mechanism 10 may have more than two portions, and/or more than one
wire for deflecting the distal end in multiple directions. For
example, one wire may be responsible for deflecting the distal end
in one direction, and the other wire may be responsible for
deflecting the distal end in another direction, for example an
opposite direction.
[0060] To deflect the distal end of device 1, a user manipulates
handle 400 to cause movement of the deflector wire 150. The user
moves the deflection handle 409 relative to the central shaft 404.
The user may first grasp either the central stop 408 or the
proximal stop 414 with one hand, and then with the other hand grasp
the deflection handle 409, for example, at the deflection grasping
portion 410. The user then may move the deflection handle 409
proximally along the central shaft 404 of the central shaft
deflection portion 413. Movement of deflection handle 409 away from
central stop 408 and towards proximal stop 414 pulls wire 150 in
handle 400, increasing the length of the deflector wire 150 in the
handle 400. For example, the deflection handle 409 may move the
deflector wire 150 proximally with respect to the rest of the
handle portion 400, such that a portion of the deflector wire 150
previously in and around the handle interface 203 of the elongate
member 200 may exit the handle interface 203 and enter the handle
portion 400 through interface 403. In some embodiments, the distal
end of the proximal stop 414 may come into contact with the
proximal end of the deflection handle 409 and prevent further
proximal movement of the deflection handle 409 along the central
shaft 404. Accordingly, further intake of the deflector wire 150
into the central shaft 404 of the handle portion 400 may be
prevented.
[0061] This movement of handle 409 and wire 150 causes the
deflector wire 150 in elongate member 200 to shift longitudinally
relative to the elongate member 200. This causes at least a portion
of the deflector wire 150 in the proximal portion 110 of the
deflecting mechanism 10 to move towards the proximal end 121 of the
proximal portion 110, and some of the deflector wire 150 that was
previously in the distal portion 130 of the deflecting mechanism 10
to enter the wire shaft 116 of the proximal portion 110 through the
distal gap 119 and/or the wire gap 114. The length of the deflector
wire 150 actually within the confines of the proximal portion 110
may stay the same length, but may also be shorter due to this
movement of the deflector wire 150. For example, the deflector wire
150 may originally have extended from the distal gap 119 on the
distal end 122 of the proximal portion 110, through the wire shaft
116, and finally through the proximal opening 118 of the proximal
end 121 of the proximal portion 110. However, due to the movement
of the deflector wire 150, while the deflector wire 150 may still
run through the proximal opening 118 of the proximal end 121 of the
proximal portion 110, on the opposite end of the proximal portion
110, the deflector wire 150 may now run through a portion of the
wire gap 114 as opposed to the distal gap 119. Further movement of
the deflector wire 150 may cause the deflector wire 150 to move in
the distal gap 114 closer to the wire gap wall 117. This may be due
to the interaction between the proximal portion 110, the distal
portion 130, and the pivot portion 170. Details of this interaction
are set forth below.
[0062] In the distal portion 130 of deflecting mechanism 10, the
movement of the deflector wire 150 may cause the deflector wire 150
to try to move towards and through the proximal gap 139 of the
distal portion 130 and the distal gap 119 of the proximal portion
110. However, because wire 150 connects to the distal portion 130
at the deflector wire connector 141, wire 150 is prevented from
moving through the proximal gap 139. Accordingly, the deflector
wire 150 may come under tension between a force from the handle
portion 400 attempting to pull the deflector wire 150, and the
deflector wire connector 141 on the distal portion 130 of the
deflecting mechanism 10. Tension on the deflector wire 150 causes
the distal portion 130 of the deflecting mechanism 10 to pivot at
its pivot interface 132, so that wire gaps 114, 134 rotate towards
each other, the external surfaces of the wire containing walls 115,
135 rotate away from each other, and the external surfaces of the
wire gap walls 117, 137 rotate towards each other. The distal end
142 of the distal portion 130 likewise pivots around its pivot
interface 132 towards the side of the distal portion 130 containing
the wire gap 134 and wire gap wall 137. Rotation of the distal
portion 130 with respect to the proximal portion 110 around the
pivot interfaces 112, 132 of the pivot portion 170 continues until
the user ceases the movement of the deflector wire 150. Rotation of
the distal portion 130 with respect to the proximal portion 110
also may stop when some portion of the distal portion 130, for
example the wire gap wall 137 or sidewalls 144, either enters the
wire shaft 116 through the wire gap 114 or comes into contact with
a distal part of the wire gap wall 117 on the proximal portion
110.
[0063] During the movement and/or rotation of the proximal portion
110 and distal portion 130 of the deflecting mechanism 10 with
respect to each other, the position of the deflector wire 150
gradually changes. Initially, the deflector wire 150 runs from the
handle portion through the elongate member 200, the proximal
portion 110, and the distal portion 130 such that the deflector
wire 150 is contained within and substantially parallel to the
longitudinal axes of the above components. During the movement
and/or rotation of the proximal portion 110 and distal portion 130
of the deflecting mechanism 10, however, the deflector wire 150
exits the confines proximal portion 110 and distal portion 130
through the wire gaps 114, 134. Accordingly, as depicted in the
exemplary embodiment shown in FIG. 1a, the deflector wire 150 moves
closer to the distal end of the wire gap wall 117 and exits the
proximal portion 110 through a portion of the wire gap 114.
Depending on the amount the distal portion 130 of the deflecting
mechanism 10 has pivoted, the deflector wire 150 exits the proximal
portion 110 closer to the distal side 122 or the wire gap wall side
117 of the wire gap 114. If the distal portion 130 of the
deflecting mechanism 10 pivots such that a portion of its sidewalls
144 or wire gap wall 137 enter the wire gap and contact the distal
end of the wire gap wall 117 of the proximal portion 110, the
deflector wire 150 enters the distal portion 130 through the wire
gap 134 while it is still also in the wire shaft 116 of the
proximal portion 110.
[0064] Controlling the movement of the deflector wire 150 controls
how much the distal portion 130 pivots with respect to the proximal
portion 110 of the deflecting mechanism 10. Once the user decides
the distal portion 130 has rotated enough and the desired angle has
been achieved, the user ceases manipulating the handle portion 400
by stopping the movement of the deflection handle 409 relative to
the rest of the handle portion 400 of the device 1. This stops the
movement of the deflector wire 150 and ceases the rotation of the
distal portion 130 around the pivot portion 170. Device 1 may
include a means to lock the deflection handle 409 with respect to
the rest of the handle portion 400 so that the deflecting mechanism
retains its position without a user needing to hold deflection
handle 409 in place.
[0065] Once the rotation of the distal portion 130 of the
deflecting mechanism 10 has stopped, the user can manipulate the
actuator wire 160 of the device 1. Accordingly, the user grabs the
handle portion 400 of the device 1 and moves the actuation handle
405 relative to the central shaft 404. Specifically, the user first
grabs either the central stop 408 or the proximal stop 414 with one
hand, and then with the other hand grabs the actuation handle 405
at the actuation grasping portion 406. The user then moves the
actuation handle 405 distally along the central shaft 404 of the
central shaft actuation portion 412, away from the distal end of
the central stop 408, and towards the interface 403. The movement
of the actuation handle 405 shortens the length of the actuator
wire 160 in the handle portion 400, and moves the actuator wire 160
distally with respect to the rest of the handle portion 400 and the
elongate member 200. In some embodiments, there may be a mechanism
for preventing the distal movement of the actuation portion past a
certain point with respect to the central shaft 404 and/or the rest
of the handle portion 400.
[0066] Upon user manipulation of the handle portion, the actuator
wire 160 moves with respect to the elongate member 200 and the
deflecting mechanism 10. Specifically, the actuator wire 160 moves
with respect to the elongate member 200 and the deflecting
mechanism 10 in a manner substantially similar to the deflector
wire 150 as set forth above, except that the actuator wire 160
moves distally instead of proximally. The movement of the actuator
wire 160 distally causes end effector assembly 300 of the device 1
to actuate, for example, the grasper jaws 303 to open. Moving the
actuator wire 160 distally causes the joints of the opposing bar
linkages 304 to spread and hence cause the grasper jaws 303 to open
(i.e. the distal ends of the grasper jaws 303 to spread apart) due
to the common distal joint for the opposing bar linkages 304.
[0067] The user continues to manipulate the handle portion 400
until either the user decides the end effector assembly 300 has
been adequately actuated, or the handle portion 400 physically
stops the actuation. There are various reasons why and how the user
decides that the end effector assembly 300 of the device 1 has been
adequately actuated, for example, whether the grasper jaws 303 have
been sufficiently opened. For example, the user may have a view of
the grasper jaws 303 through a visual component of an endoscope,
and may decide that the grasper jaws 303 has been sufficiently
opened so that they are in an ideal position to grab, for example,
a lesion. In another example, the user may decide that the grasper
jaws 303 should be opened a specific distance. In such an example,
there may be predetermined markings or specific mechanisms (for
example, locks or additional adjustable stops) on the handle
portion 400 that allow a user to ascertain exactly how much
movement of the actuation handle 405 of the handle portion 400 will
allow the grasper jaws 303 to open the desired distance.
[0068] Once the grasper jaws 303 are open, the grasper jaws 303 are
advanced further into the tissue tract or bodily organ, for
example, to grasp a lesion. In order to grasp a lesion, the user
manipulates the handle portion 400 of the device 1 to cause the
actuator wire 160 to move proximally. Specifically, the user grabs
or continues to hold either the central stop 408 or the proximal
stop 414 with one hand, and with the other hand grabs or continues
to grab the actuation handle 405 at the actuation grasping portion
406. Once the user has grabbed or continued to grasp the actuation
grasping portion 406, the user moves the actuation handle 405
proximally along the central shaft 404 of the central shaft
actuation portion 412, and towards the distal end of the central
stop 408 and away from the connector interface 403. The movement of
the actuation handle 405 lengthens the length of the actuator wire
160 in the handle portion 400, and moves the actuator wire 160
proximally with respect to the rest of the handle portion 400 and
the elongate member 200. In some embodiments, the distal end of the
central stop 408 may prevent the proximal movement of the actuation
portion past a certain point with respect to the central shaft 404
and/or the rest of the handle portion 400.
[0069] Upon user manipulation of the handle portion 400, the
actuator wire 160 shifts proximally with respect to the elongate
member 200 and the deflecting mechanism 10. Specifically, the
actuator wire 160 moves with respect to the elongate member 200 and
the deflecting mechanism 10 in a manner substantially similar to
the proximal movement of the deflector wire 150 as set forth above.
The proximal movement of the actuator wire 160 causes the grasper
jaws 303 to close around the lesion and securely grasp the lesion.
More specifically, the grasper jaws 303 have a cross-bar linkage
304 that, upon moving the actuator wire 160 proximally, causes the
joints of the opposing bar linkages 304 to come together and hence
cause the grasper jaws 303 to close (i.e. the distal ends of the
grasper jaws 303 to come together).
[0070] At this point, if desired for a particular procedure, the
user may manipulate the handle portion 400 of the device 1 to cause
the deflector wire 150 to move distally with respect to the
elongate member 200 and causes the deflecting mechanism 10 to
return to its original, substantially straight configuration. To do
this, the user grabs or continues to grab the deflection handle 409
at the deflection grasping portion 410 and either the central stop
408 or the proximal stop 414. The user then moves the deflection
handle 409 proximally along the central shaft 404, towards the
distal end of the central stop 408, and away from the distal end of
the proximal stop 414. The movement causes the deflector wire 150
to shift proximally in the central hollow portion of the central
shaft 404, and reduce the length of the deflector wire 150 in the
central shaft 404. The deflector wire 150 then shifts proximally in
the entire length of the elongate member 200. The proximal shift of
the deflector wire 150 causes the portion of the deflector wire 150
in the deflecting mechanism 10 to lengthen, and hence causes the
deflecting mechanism 10 to straighten out. Specifically, the
portion of the deflector wire 150 that exited the deflecting
mechanism 10 through the wire gaps 114, 134 now reenters the
deflecting mechanism 10 through those same wire gaps 114, 134 and
is now once again completely contained within the deflecting
mechanism 10. The lengthening of the deflector wire 150 pushes the
distal portion 130 at the deflector wire connector 141. The pushing
causes the external portions of the wire containing walls 115, 135
to rotate towards each other and the external portions of the wire
gaps walls 117, 137 to rotate away from each other. Once the
deflecting mechanism 10 has straightened, returned to its original
configuration and/or assumed any other desired angle, the
deflection handle 409 ceases moving proximally either due to user
manipulation, its abutment against the proximal end 408, or some
other structural mechanism in the handle portion 400.
[0071] In an exemplary embodiment, the device 1, and its various
components may have various dimensions. For example, the length of
the elongate member 200 connecting the handle portion 400 to the
deflecting mechanism 10 may be about 72 cm. In another example, the
length of the deflecting mechanism 10, when the proximal portion
110 and the distal portion 130 are engaged, may be about 11 mm. Of
that, the length of the proximal portion 110 may be about 7 mm. The
length of the end effector assembly 300, for example, including
grasper jaws 303 may be about 19 mm. It should be understood,
however, that these dimensions are only exemplary, and that the
device 1 and its various components may have any dimensions
necessary or desired.
[0072] In various methods of using device 1 with deflecting
mechanism 10, device 1 may be placed in the desired tissue tract or
internal organ in combination with and/or through the use of an
endoscope. The endoscope may be placed at the desired tissue tract
location using any suitable method known in the art. The device 1
may be advanced into the tissue tract through a working channel or
lumen of the endoscope. Once the device 1 exits the distal end of
the endoscope and is positioned at the desired location in the
tissue tract, the user deflects the deflecting mechanism 10 and
actuates the end effector assembly 300 as set forth above. Once the
user has completed manipulating the deflecting mechanism 10 and/or
the end effector assembly 300, the user may retract the device 1
out of the working channel or lumen of the endoscope. Any suitable,
known methods of visualizing the site and/or procedure may be used,
including various electronic imaging techniques.
[0073] In various other exemplary methods, device 1 with deflecting
mechanism 10 may be used in conjunction with a full thickness
resection device (FTRD), for example, of the type disclosed in U.S.
Pat. No. 6,398,795 to McAlister et al. The FTRD may be used in
combination with an endoscope as described in that patent. In this
exemplary embodiment, the FTRD extends over the endoscope and
accommodates the device 1. As an initial step in the method, the
user uses a method known in the art to advance an endoscope into
the body and gain access to the treatment site via the endoscope.
The user then advances the FTRD along the endoscope until the FTRD
is positioned at the treatment site.
[0074] Once the FTRD is positioned at the treatment site, an
opening is formed at the distal end of the FTRD. The opening may be
on any portion of the distal end of the FTRD and may face in any
direction from the FTRD. As an example, the opening is formed on
the side of the distal end and faces a direction perpendicular to
the longitudinal axis of the FTRD. The device 1 with the deflecting
mechanism 10 and grasper jaws 303 is then advanced to the treatment
site through the FTRD. The advancement may occur at any time, for
example, prior, during, or after positioning the FTRD at the
treatment site and/or prior, during, or after forming the opening
in the FTRD. Once the device 1 is positioned at the treatment site,
the user deflects the deflection mechanism 10 as set forth above.
At this point, portions of the device 1, for example the end
effector assembly 300 and/or a part of the distal portion 130 of
the deflecting mechanism 10, may extend through the distal opening
on the FTRD and out into the tissue tract or other bodily organ. In
the alternative, however, the grasper jaws 303 of the device 1 may
be advanced through the opening on the FTRD and out into the tissue
tract or other bodily organ after deflection of the deflecting
mechanism 10.
[0075] Once the grasper jaws 303 have advanced through the FTRD
distal opening, the user positions the grasper jaws 303 next to the
lesion and grabs the lesion with the grasper jaws 303 as set forth
above. The user then brings the lesion into the FTRD by
straightening the deflecting mechanism 303 and/or retracting device
1 into the FTRD. Once the grasper jaws 303 and the lesion are fully
through the opening of the FTRD, the user actuates a portion of the
FTRD that cuts the lesion off of the tissue tract or bodily organ.
Substantially simultaneously with, or shortly after, the cutting of
the lesion, the FTRD staples the portions of the tissue tract or
bodily organ formerly around the lesion together so as to close the
cut portion. Stapling the tissue portions may prevent infection
and/or facilitate healing of the tissue tract and/or bodily organ.
Once the desired tissue section has been cut and the surrounding
tissue has been stapled, the user removes the cut tissue from the
body. This may be done by retracting the device 1 and/or the FTRD
out of the body.
[0076] In the various embodiments, device with a deflecting
mechanism according to the invention may be used in any suitable
medical procedure, including any endoscopic procedure, and in any
suitable non-medical procedure. In the various embodiments, the end
effector assembly may be any type of medical or non-medical end
effector, for example other grasping devices, biopsy jaws, snares,
baskets, suction devices, cutters, screwdrivers, aspiration
devices, and fluid delivery devices, among other things. The device
1 may also be used in various non-medical procedures.
[0077] In the various embodiments, a device with a deflecting
mechanism according to the invention may have various alternative
configurations. For example, the user's manipulation of the handle
may include turning a knob, pushing a button, pulling a handle, or
it may even be an oral command to an electronic mechanism. The
connection of the end effectors (such as graspers) to the actuation
mechanism may also have various configurations known in the medical
device or other mechanical arts.
[0078] Other embodiments of the invention will be apparent to those
skilled in the art from consideration of the specification and
practice of the invention disclosed herein. It is intended that the
specification and examples be considered as exemplary only, with a
true scope and spirit of the invention being indicated by the
following claims.
* * * * *