U.S. patent application number 12/846228 was filed with the patent office on 2011-01-13 for motor driven surgical fastener device with cutting member lockout arrangements.
This patent application is currently assigned to EthiconEndo-Surgery, Inc.. Invention is credited to Daniel J. Abbott, Chad P. Boudreaux, Steven G. Hall, Ryan J. Laurent, Richard F. Schwemberger, Frederick E. Shelton, IV, Bret W. Smith, David C. Yates.
Application Number | 20110006101 12/846228 |
Document ID | / |
Family ID | 62142934 |
Filed Date | 2011-01-13 |
United States Patent
Application |
20110006101 |
Kind Code |
A1 |
Hall; Steven G. ; et
al. |
January 13, 2011 |
MOTOR DRIVEN SURGICAL FASTENER DEVICE WITH CUTTING MEMBER LOCKOUT
ARRANGEMENTS
Abstract
A surgical fastener apparatus having a handle, an elongated
shaft having a proximal end attached to the handle and a distal end
extending therefrom. An end effector including a pair of jaws
pivoted at a proximal end thereof and movable between an open and
closed position. A cartridge containing a plurality of surgical
fasteners, the cartridge attached to the end effector. An
electrically powered actuator for deploying the surgical fasteners,
the actuator having a power source and a motor. A first trigger
attached to the handle for moving the end effector from the open to
the closed position, and a second trigger attached to the handle
for activating the actuator. A first lockout mechanism for
preventing current from flowing from the power source to the motor
unless the end effector is in its closed position a second lockout
mechanism having a locked and unlocked position, the second lockout
mechanism for preventing movement of the second trigger until the
second lockout mechanism is moved to the unlocked position.
Inventors: |
Hall; Steven G.;
(Cincinnati, OH) ; Smith; Bret W.; (Kings Mills,
OH) ; Schwemberger; Richard F.; (Cincinnati, OH)
; Abbott; Daniel J.; (Loveland, OH) ; Laurent;
Ryan J.; (Liberty Township, OH) ; Yates; David
C.; (West Chester, OH) ; Shelton, IV; Frederick
E.; (Hillsboro, OH) ; Boudreaux; Chad P.;
(Cincinnati, OH) |
Correspondence
Address: |
K&L Gates LLP
210 SIXTH AVENUE
PITTSBURGH
PA
15222-2613
US
|
Assignee: |
EthiconEndo-Surgery, Inc.
Cincinnati
OH
|
Family ID: |
62142934 |
Appl. No.: |
12/846228 |
Filed: |
July 29, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12693460 |
Jan 26, 2010 |
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12846228 |
|
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61150382 |
Feb 6, 2009 |
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Current U.S.
Class: |
227/175.2 |
Current CPC
Class: |
A61B 2017/00398
20130101; A61B 2017/07285 20130101; A61B 2090/306 20160201; A61B
17/07207 20130101; A61B 17/068 20130101; A61B 90/30 20160201; A61B
2017/07278 20130101; A61B 2017/320052 20130101; A61B 2017/00734
20130101; A61B 2090/304 20160201; A61B 2017/07214 20130101; A61B
2090/309 20160201; A61B 2017/2946 20130101 |
Class at
Publication: |
227/175.2 |
International
Class: |
A61B 17/068 20060101
A61B017/068 |
Claims
1. A surgical fastener apparatus comprising: a. a handle, an
elongated shaft having a proximal end attached to said handle and a
distal end extending therefrom, an end effector comprising a pair
of jaws pivoted at a proximal end thereof and movable between an
open and closed position, and a cartridge containing a plurality of
surgical fasteners, said cartridge attached to said end effector;
b. an electrically powered actuator for deploying said surgical
fasteners, said actuator comprising a power source and a motor; c.
a first trigger attached to said handle for moving said end
effector from said open to said closed position, and a second
trigger attached to said handle for activating said actuator; d. a
first lockout mechanism for preventing current from flowing from
said power source to said motor unless said end effector is in its
closed position; and e. a second lockout mechanism having a locked
and unlocked position, said second lockout mechanism for preventing
movement of said second trigger until said second lockout mechanism
is moved to said unlocked position.
2. The surgical fastener apparatus of claim 1 wherein said first
lockout mechanism comprises: a latch operably mounted to one of
said handle and said first trigger portion for releasably retaining
the first trigger in a position corresponding to said closed
position of said end effector; and a closure lock switch on one of
said handle and latch, said closure lock switch connected to said
power source and said motor such that when said latch retains said
first trigger in said position corresponding to said closed
position of said end effector, said closure lock switch permits
current to flow from said power source to said motor and when said
first trigger is not in said position corresponding to said closed
position, said closure lock switch prevents current from flowing
from said power source to said motor.
3. The surgical fastener apparatus of claim 1 wherein said second
lockout mechanism comprises a start switch connected to said power
source and said motor and configured to prevent current from
flowing from said power source to said motor unless said start
switch is activated.
4. The surgical fastener apparatus of claim 1 wherein said second
lockout mechanism comprises a movable member on said handle, said
movable member movable between a first position wherein movement of
said second trigger is prevented and a second position wherein said
second trigger may be activated.
5. The surgical fastener apparatus of claim 1 wherein said
cartridge is removably supported within a channel portion of said
end effector and wherein said surgical fastener apparatus comprises
a cartridge sensor switch connected to said power source and said
motor, said cartridge sensor switch preventing current from flowing
from said power source to said motor unless a cartridge is operably
supported within said channel portion of said end effector.
6. The surgical fastener apparatus of claim 1 wherein said actuator
further comprises an actuator portion that is movable within said
end effector between an unactuated position to actuated positions
and wherein said motor operably interfaces with said actuator
portion to selectively apply a distal driving motion thereto to
move said actuator portion from said unactuated position to said
actuated positions and to selectively apply a proximal driving
motion to said actuator portion to retract said actuator portion to
said unactuated position from said actuated positions.
7. The surgical fastener apparatus of claim 1 wherein said
electrically powered actuator further comprises: a rotary drive
shaft rotatably supported within said end effector and operably
coupled to said motor for receiving rotary motion therefrom; and an
actuator portion operably interfacing with said rotary drive shaft
such that, upon application of current in a first direction to said
motor, said actuator portion is driven from an unactuated position
to an actuated position within said end effector and upon
application of current in a second direction to said motor, said
actuator portion is driven from said actuated position to said
unactuated position.
8. The surgical fastener apparatus of claim 7 wherein said actuator
portion comprises a cutting member and a sled portion for applying
actuation motions to said plurality of surgical fasteners within
said cartridge.
9. The surgical fastener apparatus of claim 2 wherein said latch
comprises a hook pivotally attached to said handle and selectively
movable from an unlatched position to a latched position wherein
said hook retainingly engages a portion of said first trigger.
10. The surgical fastener apparatus of claim 9 wherein said hook is
biased into said latched position.
11. A surgical fastener apparatus comprising: a handle; an end
effector operably coupled to said handle and having a movable anvil
supported thereon, said movable anvil movable between open and
closed positions in response to open and closing motions applied to
a closure trigger operably supported on said handle; an actuator
movable within said end effector between an unactuated position to
actuated positions within said end effector; an electric motor
operably interfacing with said actuator to selectively apply a
distal driving motion thereto to move said actuator from said
unactuated position to said actuated positions and to selectively
apply a proximal driving motion to said actuator to retract said
actuator to said unactuated position from said actuated positions;
a power source connected to said motor for electrically powering
the motor; and a current control circuit connected to the power
source for controlling current supplied to said motor from said
power source, said current control circuit comprising: a closure
lock switch connected to said power source and said motor such that
when said closure trigger is retained in a locked position wherein
said anvil is retained in said closed position, said closure lock
switch permits current to flow from said power source to said motor
and when said closure trigger is not in said locked position, said
closure lock switch prevents current from flowing from said power
source to said motor; and a start switch connected to said power
source and said motor and preventing current from flowing from said
power source to said motor unless said start switch is manually
activated.
12. The surgical fastening apparatus of claim 11 further comprising
a latch movably coupled to said handle and configured to
releaseably retain said closure trigger in said locked
position.
13. The surgical fastening apparatus of claim 12 wherein said
closure lock stitch is mounted to said latch.
14. The surgical fastening apparatus of claim 11 further comprising
a firing trigger operably coupled to said handle and wherein said
current control circuit comprises a run motor control switch
connected to said power source and operated by said firing trigger
such that upon application of an actuation motion to said firing
trigger, said run motor switch permits current to flow to said
motor in a first direction to cause said motor to apply said distal
driving motion to said actuator.
15. A surgical fastener apparatus comprising: a handle; an end
effector operably coupled to said handle and having a movable anvil
supported thereon, said movable anvil movable between open and
closed positions in response to open and closing motions applied to
a closure trigger operably supported on said handle; an actuator
movable within said end effector between an unactuated position to
actuated positions within said end effector; an electric motor
operably interfacing with said actuator to selectively apply a
distal driving motion thereto to move said actuator from said
unactuated position to said actuated positions and to selectively
apply a proximal driving motion to said actuator to retract said
actuator to said unactuated position from said actuated positions;
a power source connected to said motor for electrically powering
the motor; a firing trigger operably supported on said handle and
movable between actuated and unactuated positions; a firing switch
coupled to said power source and said motor and interfacing with
said firing trigger such that, upon movement of said firing trigger
from said unactuated position to said actuated positions, said
firing switch permits current to flow to said motor to apply said
distal driving motion to said actuator; a closure lock switch
connected to said power source and said motor such that when said
closure trigger is retained in a locked position wherein said anvil
is retained in said closed position, said closure lock switch
permits current to flow from said power source to said motor and
when said closure trigger is not in said locked position, said
closure lock switch prevents current from flowing from said power
source to said motor; and a movable lock member movable between a
first position wherein movement of said second trigger from said
unactuated position to said actuated positions is prevented and a
second position wherein said second trigger may be moved from said
unactuated position to said actuated positions.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This non-provisional application is a continuation-in-part
application of U.S. patent application Ser. No. 12/693,460,
entitled "Driven Surgical Stapler Improvements", to Steven G. Hall,
filed on Jan. 26, 2010, which claims the benefit of U.S.
Provisional Application Ser. No. 61/150,382 entitled "Motor-Driven
Surgical Stapler Improvements" to Steven G. Hall filed on Feb. 6,
2009, the entire disclosures of each being herein incorporated by
reference in their respective entireties.
BACKGROUND
[0002] An example of a surgical stapler suitable for endoscopic
applications is described in U.S. Pat. No. 5,465,895, which is
hereby incorporated herein by reference in its entirety. Such
device comprises an endocutter that has distinct closing and firing
actions. Another example of a motor driven surgical stapler is
disclosed U.S. Patent Application Publication No. US 2007/0175958
A1, entitled "Motor-Driven Surgical Cutting and Fastening
Instrument With User Feedback System", published Aug. 2, 2007 which
is hereby incorporated herein by reference in its entirety.
Excerpts of such Publication are presented here to detail its base
functions, improvements, background, and components. At the end,
additional improvements to the system are disclosed.
[0003] U.S. Patent Application Publication No. US 2007/0175958 A1
provides in part that "[a] clinician using this device is able to
close the jaw members upon tissue to position the tissue prior to
firing. Once the clinician has determined that the jaw members are
properly gripping tissue, the clinician can then fire the surgical
stapler with a single firing stroke, or multiple firing strokes,
depending on the device. Firing the surgical stapler causes
severing and stapling the tissue. The simultaneous severing and
stapling avoids complications that may arise when performing such
actions sequentially with different surgical tools that
respectively only sever and staple."
[0004] One specific advantage of being able to close upon tissue
before firing is that the clinician is able to verify via an
endoscope that the desired location for the cut has been achieved,
including a sufficient amount of tissue has been captured between
opposing jaws. Otherwise, opposing jaws may be drawn too close
together, especially pinching at their distal ends, and thus not
effectively forming closed staples in the severed tissue. At the
other extreme, an excessive amount of clamped tissue may cause
binding and an incomplete firing.
[0005] Endoscopic staplers/cutters continue to increase in
complexity and function with each generation. One of the main
reasons for this is the quest for lower force-to- fire (FTF) to a
level that all or a great majority of surgeons can handle. One
known solution to lower FTF is to use C02 or electrical motors.
These devices have not faired much better than traditional
hand-powered devices, but for a different reason. Surgeons
typically prefer to experience proportionate force distribution to
that being experienced by the end-effector in the forming the
staple to assure them that the cutting/stapling cycle is complete,
with the upper limit within the capabilities of most surgeons
(usually around 15-30 lbs). They also typically want to maintain
control of deploying the staple and being able to stop at anytime
if the forces felt in the handle of the device feel too great or
for some other clinical reason. These user-feedback effects are not
suitably realizable in present motor-driven endocutters. As a
result, there is a general lack of acceptance by physicians of
motor-drive endocutters where the cutting/stapling operation is
actuated by merely pressing a button.
[0006] The foregoing discussion is intended only to illustrate some
of the shortcomings present in the field of the invention at the
time, and should not be taken as a disavowal of claim scope.
SUMMARY
[0007] In accordance with one general aspect of the present
invention, there is provided a surgical fastener apparatus that
includes a handle and an elongated shaft that has a proximal end
attached to the handle. The elongated shaft further has a distal
end that extends therefrom and is coupled to an end effector that
comprises a pair of jaws that are pivoted at a proximal end thereof
and movable between an open and closed position. The end effector
has a cartridge attached thereto that contains a plurality of
surgical fasteners. The apparatus further includes an electrically
powered actuator for deploying the surgical fasteners. In various
embodiments, the actuator comprises a power source and a motor. A
first trigger is attached to the handle for moving the end effector
from the open to the closed position. A second trigger is attached
to the handle for activating the actuator. The apparatus further
comprises a first lockout mechanism for preventing current from
flowing from the power source to the motor unless the end effector
is in its closed position. The apparatus further comprises a second
lockout mechanism that has a locked and unlocked position. The
second lockout mechanism being configured to prevent movement of
the second trigger until the second lockout mechanism is moved to
the unlocked position.
[0008] In accordance with another general aspect of the present
invention, there is provided a surgical fastener apparatus that
includes a handle that has an end effector operably coupled
thereto. The end effector has a movable anvil supported thereon.
The movable anvil being movable between open and closed positions
in response to open and closing motions applied to a closure
trigger that is operably supported on the handle. An actuator is
movable within the end effector between an unactuated position to
actuated positions within the end effector. An electric motor
operably interfaces with the actuator to selectively apply a distal
driving motion thereto to move the actuator from the unactuated
position to the actuated positions and to selectively apply a
proximal driving motion to the actuator to retract the actuator to
the unactuated position from the actuated positions. A power source
is connected to the motor for electrically powering the motor. The
apparatus further comprises a current control circuit that is
connected to the power source for controlling current supplied to
the motor from the power source. In various embodiments, the
current control circuit comprises a closure lock switch that is
connected to the power source and the motor such that when the
closure trigger is retained in a locked position wherein the anvil
is retained in the closed position, the closure lock switch permits
current to flow from the power source to the motor and when the
closure trigger is not in the locked position, the closure lock
switch prevents current from flowing from the power source to the
motor. A start switch is connected to the power source and the
motor for preventing current from flowing from the power source to
the motor unless the start switch is manually activated.
[0009] In accordance with yet another general aspect of the present
invention, there is provided a surgical fastener apparatus that
includes a handle that has an end effector operably coupled
thereto. The end effector has a movable anvil supported thereon.
The movable anvil is movable between open and closed positions in
response to open and closing motions applied to a closure trigger
operably supported on the handle. An actuator is movable within the
end effector between an unactuated position to actuated positions
within the end effector. An electric motor operably interfaces with
the actuator to selectively apply a distal driving motion thereto
to move the actuator from the unactuated position to the actuated
positions and to selectively apply a proximal driving motion to the
actuator to retract the actuator to the unactuated position from
the actuated positions. A power source is connected to the motor
for electrically powering the motor. A firing trigger is operably
supported on the handle and is movable between actuated and
unactuated positions. A firing switch is coupled to the power
source and the motor and interfaces with the firing trigger such
that, upon movement of the firing trigger from the unactuated
position to the actuated positions, the firing switch permits
current to flow to the motor to apply the distal driving motion to
the actuator. A closure lock switch is connected to the power
source and the motor such that when the closure trigger is retained
in a locked position wherein the anvil is retained in the closed
position, the closure lock switch permits current to flow from the
power source to the motor and when the closure trigger is not in
the locked position, the closure lock switch prevents current from
flowing from the power source to the motor. In various embodiments,
the apparatus comprises a movable lock member that is movable
between a first position wherein movement of the second trigger
from the unactuated position to the actuated positions is prevented
and a second position wherein the second trigger may be moved from
the unactuated position to the actuated positions.
[0010] In one general aspect, the present invention is directed to
a motorized surgical cutting and fastening instrument that provides
feedback to the user regarding the position, force and/or
deployment of the end effector. The instrument, in various
embodiments, also allows the operator to control the end effector,
including being able to stop deployment if so desired. The
instrument may include two triggers in its handle--a closure
trigger and a firing trigger--with separate actuation motions. When
an operator of the instrument retracts the closure trigger, tissue
positioned in the end effector may be clamped by the end effector.
Then, when the operator retracts the firing trigger, a motor may
power, via a gear drive train, a rotational main drive shaft
assembly, which causes a cutting instrument in the end effector to
sever the clamped tissue.
[0011] In various embodiments, the instrument may comprise a power
assist system with loading force feedback and control to reduce the
firing force required to be exerted by the operator in order to
complete the cutting operation. In such embodiments, the firing
trigger may be geared into the gear drive train of the main drive
shaft assembly. In that way, the operator may experience feedback
regarding the force being applied to the cutting instrument. That
is, the loading force on the firing trigger may be related to the
loading force experienced by the cutting instrument. Also in such
embodiments, because the firing trigger is geared into the gear
drive train, force applied by the operator may be added to the
force applied to the motor.
[0012] According to various embodiments, when the firing trigger is
retracted an appropriate amount (e.g., five degrees), an on/off
switch may be actuated, which sends a signal to the motor to rotate
at a specified rate, thus commencing actuation of the drive shaft
assembly and end effector. According to other embodiments, a
proportional sensor may be used. The proportional sensor may send a
signal to the motor to rotate at a rate proportional to the force
applied to the firing trigger by the operator. In that way, the
rotational position of the firing trigger is generally proportional
to where the cutting instrument is in the end effector (e.g., fully
deployed or fully retracted). Further, the operator could stop
retracting the firing trigger at some point in the stroke to stop
the motor, and thereby stop the cutting motion. In addition,
sensors may be used to detect the beginning of the stroke of the
end effector (e.g., fully retracted position) and the end of the
stroke (e.g., fully deployed position), respectively. Consequently,
the sensors may provide an adaptive control system for controlling
end effector deployment that is outside of the closed loop system
of the motor, gear drive train, and end effector.
[0013] In other embodiments, the firing trigger may not be directly
geared into the gear drive train used to actuate the end effector.
In such embodiments, a second motor may be used to apply forces to
the firing trigger to simulate the deployment of the cutting
instrument in the end effector. The second motor may be controlled
based on incremental rotations of the main drive shaft assembly,
which may be measured by a rotary encoder. In such embodiment, the
position of the rotational position of the firing trigger may be
related to the position of the cutting instrument in the end
effector. Additionally, an on/off switch or a proportional switch
may be used to control the main motor (i.e., the motor that powers
the main drive shaft).
[0014] In various implementations, the end effector may use a
helical drive screw in the base of the end effector to drive the
cutting instrument (e.g., knife). Also, the end effector may
include a staple cartridge for stapling the severed tissue.
According to other embodiments, other means for fastening (or
sealing) the severed tissue may be used, including RF energy and
adhesives.
[0015] Also, the instrument may include a mechanical closure
system. The mechanical closure system may include an elongate
channel having a clamping member, such as an anvil, pivotably
connected to the channel to clamp tissue positioned in the end
effector. The user may activate the clamping action of the end
effector by retracting the closer trigger, which, through a
mechanical closure system, causes the clamping action of the end
effector. Once the clamping member is locked in place, the operator
may activate the cutting operation by retracting the separate
firing trigger. This may cause the cutting instrument to travel
longitudinally along the channel in order to cut tissue clamped by
the end effector.
[0016] In various implementations, the instrument may include a
rotational main drive shaft assembly for actuating the end
effector. Further, the main drive shaft may comprise an
articulating joint such that the end effector may be articulated.
The articulation joint may comprise, for example, a bevel gear
assembly, a universal joint, or a flexible torsion cable capable of
transmitting torsion force to the end effector.
[0017] Other aspects of the present invention are directed to
various mechanisms for locking the closure trigger to a lower,
pistol-grip portion of the handle. Such embodiments free up space
in the handle directly above and behind the triggers for other
components of the instrument, including components of the gear
drive train and the mechanical closure system."
[0018] The disclosure herein shows how one could embody a battery
powered gear driven self-contained endoscopic stapling device.
BRIEF DESCRIPTION OF DRAWINGS
[0019] The above-mentioned and other features and advantages of
this invention, and the manner of attaining them, will become more
apparent and the invention itself will be better understood by
reference to the following description of embodiments of the
invention taken in conjunction with the accompanying drawings,
wherein:
[0020] FIGS. 1 and 2 are perspective views of a surgical cutting
and fastening instrument according to various embodiments of the
present invention;
[0021] FIGS. 3-5 are exploded views of an end effector and shaft of
the instrument according to various embodiments of the present
invention;
[0022] FIG. 6 is a side view of the end effector according to
various embodiments of the present invention;
[0023] FIG. 7 is an exploded view of the handle of the instrument
according to various embodiments of the present invention;
[0024] FIGS. 8 and 9 are partial perspective views of the handle
according to various embodiments of the present invention;
[0025] FIG. 10 is a side view of the handle according to various
embodiments of the present invention;
[0026] FIGS. 10A-10B illustrate a proportional sensor or switch
that may be used according to various embodiments of the present
invention;
[0027] FIG. 11 is a schematic diagram of a current control circuit
used in the instrument according to various embodiments of the
present invention;
[0028] FIG. 12 is a side view of another handle according to
various embodiments of the present invention;
[0029] FIG. 13 is a schematic diagram of another current control
circuit used in the instrument according to various embodiments of
the present invention;
[0030] FIG. 14 is a schematic diagram of another current control
circuit used in the instrument according to various embodiments of
the present invention;
[0031] FIG. 15 is a schematic diagram of another circuit used in
the instrument according to various embodiments of the present
invention;
[0032] FIG. 15A is a schematic diagram of another current control
circuit used in the instrument according to various embodiments of
the present invention;
[0033] FIG. 15B is a schematic diagram of another current control
circuit used in the instrument according to various embodiments of
the present invention;
[0034] FIGS. 16-17 illustrate different mechanisms for locking the
closure trigger according to various embodiments of the present
invention;
[0035] FIG. 18 is a schematic diagram of another current control
circuit used in the instrument according to various embodiments of
the present invention;
[0036] FIG. 19 is a cross-sectional view of an end effector
embodiment of the present invention;
[0037] FIG. 20 is a side elevational view of a knife assembly or
actuator embodiment of the present invention;
[0038] FIG. 21 is a side elevational view of another knife assembly
or actuator embodiment of the present invention;
[0039] FIG. 22 is a side elevational view of another knife assembly
or actuator embodiment of the present invention;
[0040] FIG. 23 is a perspective view of a distal end of surgical
stapler in accordance with an embodiment of the present
invention;
[0041] FIG. 24 is a perspective view of a distal end of surgical
stapler in accordance with an embodiment of the present invention
with the cartridge removed from the channel;
[0042] FIG. 25 is a view of a distal end of surgical stapler in
accordance with an embodiment of the present invention similar to
FIG. 1 showing a lockout indicator; and
[0043] FIG. 26 is a perspective view of a proximal end of surgical
stapler in accordance with an embodiment of the present
invention.
DETAILED DESCRIPTION OF THE INVENTION
[0044] The owner of the subject application also owns the following
U.S. Patent Applications that were filed on even date herewith and
which are each herein incorporated by reference in their respective
entirety:
[0045] U.S. Patent Application entitled "Motor Driven Surgical
Fastener Device With Cutting Member Reversing Mechanism", Attorney
Docket No. END6549USCIP1/100280CIP1; and
[0046] U.S. Patent Application entitled "Motor Driven Surgical
Fastener Device With Mechanisms For Adjusting a Tissue Gap Within
the End Effector", Attorney Docket No.
END6548USCIP1/100271CIP1.
[0047] Certain exemplary embodiments will now be described to
provide an overall understanding of the principles of the
structure, function, manufacture, and use of the devices and
methods disclosed herein. One or more examples of these embodiments
are illustrated in the accompanying drawings. Those of ordinary
skill in the art will understand that the devices and methods
specifically described herein and illustrated in the accompanying
drawings are non-limiting exemplary embodiments and that the scope
of the various embodiments of the present invention is defined
solely by the claims. The features illustrated or described in
connection with one exemplary embodiment may be combined with the
features of other embodiments. Such modifications and variations
are intended to be included within the scope of the present
invention.
[0048] Reference throughout the specification to "various
embodiments," "some embodiments," "one embodiment," or "an
embodiment", "an implementation" or "various implementations" or
the like, means that a particular feature, structure, or
characteristic described in connection with the embodiment is
included in at least one embodiment. Thus, appearances of the
phrases "in various embodiments," "in some embodiments," "in one
embodiment", or "in an embodiment", "an implementation" or "various
implementations" or the like, in places throughout the
specification are not necessarily all referring to the same
embodiment or implementation. Furthermore, the particular features,
structures, or characteristics may be combined in any suitable
manner in one or more embodiments or implementations. Thus, the
particular features, structures, or characteristics illustrated or
described in connection with one embodiment may be combined, in
whole or in part, with the features structures, or characteristics
of one or more other embodiments without limitation. Such
modifications and variations are intended to be included within the
scope of the present invention.
[0049] The terms "proximal" and "distal" are used herein with
reference to a clinician manipulating the handle portion of the
surgical instrument. The term "proximal" referring to the portion
closest to the clinician and the term "distal" referring to the
portion located away from the clinician. It will be further
appreciated that, for convenience and clarity, spatial terms such
as "vertical", "horizontal", "up", and "down" may be used herein
with respect to the drawings. However, surgical instruments are
used in many orientations and positions, and these terms are not
intended to be limiting and/or absolute.
[0050] FIGS. 1 and 2 depict a surgical cutting and fastening
instrument 10 according to various embodiments of the present
invention. The illustrated embodiment is an endoscopic surgical
instrument 10 and in general, the embodiments of the instrument 10
described herein are endoscopic surgical cutting and fastening
instruments. It should be noted, however, that according to other
embodiments of the present invention, the instrument 10 may be a
non-endoscopic surgical cutting instrument, such as a laproscopic
instrument.
[0051] The surgical instrument 10 depicted in FIGS. 1 and 2
comprises a handle 6, a shaft 8, and an articulating end effector
12 pivotally connected to the shaft 8 at an articulation pivot 14.
An articulation control 16 may be provided adjacent to the handle 6
to effect rotation of the end effector 12 about the articulation
pivot 14. It will be appreciated that various embodiments may
include a non-pivoting end effector, and therefore may not have an
articulation pivot 14 or articulation control 16. Also, in the
illustrated embodiment, the end effector 12 is configured to act as
an endocutter for clamping, severing and stapling tissue, although,
in other embodiments, different types of end effectors may be used,
such as end effectors for other types of surgical devices, such as
graspers, cutters, staplers, clip appliers, access devices,
drug/gene therapy devices, ultrasound, RF or laser devices,
etc.
[0052] The handle 6 of the instrument 10 may include a closure
trigger 18 and a firing trigger 20 for actuating the end effector
12. It will be appreciated that instruments having end effectors
directed to different surgical tasks may have different numbers or
types of triggers or other suitable controls for operating the end
effector 12. The end effector 12 is shown separated from the handle
6 by a preferably elongate shaft 8. In one embodiment, a clinician
or operator of the instrument 10 may articulate the end effector 12
relative to the shaft 8 by utilizing the articulation control 16,
as described in more detail in U.S. Pat. No. 7,670,334, entitled
"Surgical Instrument Having An Articulating End Effector," by
Geoffrey C. Hueil et al., which is incorporated herein by reference
in its entirety.
[0053] The end effector 12 includes in this example, among other
things, an elongated channel 22 configured to operably support a
staple cartridge 34 therein and a pivotally translatable clamping
member, such as an anvil 24, which are maintained at a spacing that
assures effective stapling and severing of tissue clamped in the
end effector 12. The handle 6 includes a pistol grip 26 toward
which a closure trigger 18 is pivotally drawn by the clinician to
cause clamping or closing of the anvil 24 towards the elongated
channel 22 of the end effector 12 to thereby clamp tissue
positioned between the anvil 24 and elongated channel 22. The
firing trigger 20 is farther outboard of the closure trigger 18.
Once the closure trigger 18 is locked in the closure position as
further described below, the firing trigger 20 may rotate slightly
toward the pistol grip 26 so that it can be reached by the operator
using one hand. Then the operator may pivotally draw the firing
trigger 20 toward the pistol grip 26 to cause the stapling and
severing of clamped tissue in the end effector 12. In other
embodiments, different types of clamping members besides the anvil
24 could be used, such as, for example, an opposing jaw, etc.
[0054] The closure trigger 18 may be actuated first. Once the
clinician is satisfied with the positioning of the end effector 12,
the clinician may draw back the closure trigger 18 to its fully
closed, locked position proximate to the pistol grip 26. The firing
trigger 20 may then be actuated. The firing trigger 20 returns to
the open position (shown in FIGS. 1 and 2) when the clinician
removes pressure, as described more fully below. A release button
on the handle 6, when depressed may release the locked closure
trigger 18. The release button may be implemented in various forms
such as, for example, slide release button 160 shown in FIG. 16,
and/or button 172 shown in FIG. 17.
[0055] FIGS. 3-6 show embodiments of a rotary-driven end effector
12 and shaft 8 according to various embodiments. FIG. 3 is an
exploded view of the end effector 12 according to various
embodiments. As shown in the illustrated embodiment, the end
effector 12 may include, in addition to the previously-mentioned
channel 22 and anvil 24, a cutting instrument 32, a sled 33, a
staple cartridge 34 that is removably seated in the channel 22, and
a helical screw shaft 36. The cutting instrument 32 may be, for
example, a knife. As used herein with respect to at least one
embodiment, the term "actuator" may refer to the knife and/or sled.
The anvil 24 may be pivotably opened and closed at pivot pins 25
connected to the proximate end of the channel 22. The anvil 24 may
also include a tab 27 at its proximate end that is inserted into a
component of the mechanical closure system (described further
below) to open and close the anvil 24. When the closure trigger 18
is actuated, that is, drawn in by a user of the instrument 10, the
anvil 24 may pivot about the pivot pins 25 into the clamped or
closed position. If clamping of the end effector 12 is
satisfactory, the operator may actuate the firing trigger 20,
which, as explained in more detail below, causes the knife 32 and
sled 33 to travel longitudinally along the channel 22, thereby
cutting tissue clamped within the end effector 12. The movement of
the sled 33 along the channel 22 causes the staples (not shown) of
the staple cartridge 34 to be driven through the severed tissue and
against the closed anvil 24, which turns the staples to fasten the
severed tissue. In various embodiments, the sled 33 may be an
integral component of the cartridge 34. U.S. Pat. No. 6,978,921,
entitled "Surgical Stapling Instrument Incorporating an E-beam
Firing Mechanism" to Shelton, IV et al., which is incorporated
herein by reference, provides more details about such two-stroke
cutting and fastening instruments. The sled 33 may be part of the
cartridge 34, such that when the knife 32 retracts following the
cutting operation, the sled 33 does not retract.
[0056] FIGS. 4 and 5 are exploded views and FIG. 6 is a side view
of the end effector 12 and shaft 8 according to various
embodiments. As shown in the illustrated embodiment, the shaft 8
may include a proximate closure tube 40 and a distal closure tube
42 pivotably linked by a pivot link 44. The distal closure tube 42
includes an opening 45 into which the tab 27 on the anvil 24 is
inserted in order to open and close the anvil 24, as further
described below. Disposed inside the closure tubes 40, 42 may be a
proximate spine tube 46. Disposed inside the proximate spine tube
46 may be a main rotational (or proximate) drive shaft 48 that
communicates with a secondary (or distal) drive shaft 50 via a
bevel gear assembly 52. The secondary drive shaft 50 is connected
to a drive gear 54 that engages a proximate drive gear 56 of the
helical screw shaft 36. The vertical bevel gear 52b may sit and
pivot in an opening 57 in the distal end of the proximate spine
tube 46. A distal spine tube 58 may be used to enclose the
secondary drive shaft 50 and the drive gears 54, 56. Collectively,
the main drive shaft 48, the secondary drive shaft 50, and the
articulation assembly (e.g., the bevel gear assembly 52a-c) are
sometimes referred to herein as the "main drive shaft
assembly."
[0057] A bearing 38, positioned at a distal end of the staple
channel 22, receives the helical drive screw 36, allowing the
helical drive screw 36 to freely rotate with respect to the channel
22. The helical screw shaft 36 may interface a threaded opening
(not shown) of the knife 32 such that rotation of the shaft 36
causes the knife 32 to translate distally or proximately (depending
on the direction of the rotation) through the staple channel 22.
Accordingly, when the main drive shaft 48 is caused to rotate upon
application of an actuation motion to the firing trigger 20 (as
explained in more detail below), the bevel gear assembly 52a-c
causes the secondary drive shaft 50 to rotate, which in turn,
because of the engagement of the drive gears 54, 56, causes the
helical screw shaft 36 to rotate, which causes the knife driving
member 32 to travel longitudinally along the channel 22 to cut any
tissue clamped within the end effector 12. The sled 33 may be made
of, for example, plastic, and may have a sloped distal surface. As
the sled 33 traverses the channel 22, the sloped forward surface
may push up or drive the staples in the staple cartridge through
the clamped tissue and against the anvil 24. The anvil 24 forms or
turns the staples, thereby stapling the severed tissue. When the
knife 32 is retracted, the knife 32 and sled 33 may become
disengaged, thereby leaving the sled 33 at the distal end of the
channel 22.
[0058] FIGS. 7-10 illustrate an exemplary embodiment of a
motor-driven endocutter, and in particular the handle thereof, that
provides user-feedback regarding the deployment and loading force
of the cutting instrument 32 in the end effector 12. In addition,
the embodiment may use power provided by the user in retracting the
firing trigger 20 to power the device (a so-called "power assist"
mode). The embodiment may be used with the rotary driven end
effector 12 and shaft 8 embodiments described above. As shown in
the illustrated embodiment, the handle 6 includes exterior lower
side pieces 59, 60 and exterior upper side pieces 61, 62 that fit
together to form, in general, the exterior of the handle 6. In
various embodiments, the rotary driven end effector may be powered
by a motor 65 that is disposed in an upper portion of the pistol
grip portion 26 of the handle and powered by a power source 64. The
power source 64 may comprise a battery or a supply of alternating
current. In a preferred embodiment, the power source 64 comprises a
Li ion battery that is supported in the pistol grip portion 26 of
the handle 6. According to various embodiments, the motor 65 may be
a DC brushed driving motor having a maximum rotation of,
approximately, 5000 RPM. The motor 65 may drive a 90 degree bevel
gear assembly 66 comprising a first bevel gear 68 and a second
bevel gear 70. The bevel gear assembly 66 may drive a planetary
gear assembly 72. The planetary gear assembly 72 may include a
pinion gear 74 connected to a drive shaft 76. The pinion gear 74
may drive a mating ring gear 78 that drives a helical gear drum 80
via a drive shaft 82. A ring 84 may be threaded on the helical gear
drum 80. Thus, when the motor 65 rotates, the ring 84 is caused to
travel along the helical gear drum 80 by means of the interposed
bevel gear assembly 66, planetary gear assembly 72 and ring gear
78.
[0059] The handle 6 may also include a run motor switch 110 (see
FIG. 10) in communication with the firing trigger 20 to receive an
actuation motion from the firing trigger 20 when the firing trigger
has been drawn in (or "closed") toward the pistol grip portion 26
of the handle 6 by the operator to thereby actuate the
cutting/stapling operation by the end effector 12. The run motor
switch 110 may be a proportional sensor such as, for example, a
rheostat or variable resistor. When the firing trigger 20 is drawn
in, the run motor switch 110 permits current to flow from the power
source 64 to the motor 65. When the run motor switch 110 is a
variable resistor or the like, the rotation of the motor 65 may be
generally proportional to the amount of movement of the firing
trigger 20. That is, if the operator only draws or closes the
firing trigger 20 in a small amount, the rotation of the motor 65
is relatively low. When the firing trigger 20 is fully drawn in (or
in the fully closed position), the rotation of the motor 65 is at
its maximum. In other words, the harder the user pulls on the
firing trigger 20, the more voltage is applied to the motor 65,
causing greater rates of rotation.
[0060] The handle 6 may include a middle handle piece 104 adjacent
to the upper portion of the firing trigger 20. The handle 6 may
also include a bias spring 112 that is connected between posts on
the middle handle piece 104 and the firing trigger 20. The bias
spring 112 may bias the firing trigger 20 to its fully open
position. In that way, when the operator releases the firing
trigger 20, the bias spring 112 will pull the firing trigger 20 to
its open position, thereby deactivating the run motor switch 110 to
stop rotation of the motor 65. Moreover, by virtue of the bias
spring 112, any time a user closes the firing trigger 20, the user
will experience resistance to the closing operation, thereby
providing the user with feedback as to the amount of rotation
exerted by the motor 65. Further, the operator could stop
retracting the firing trigger 20 to thereby deactivate the run
motor switch 110 and stop the motor 65. As such, the user may stop
the deployment of the end effector 12, thereby providing a measure
of control of the cutting/fastening operation to the operator.
[0061] The distal end of the helical gear drum 80 includes a distal
drive shaft 120 that drives a ring gear 122, which mates with a
pinion gear 124. The pinion gear 124 is connected to the main drive
shaft 48 of the main drive shaft assembly. In that way, rotation of
the motor 65 causes the main drive shaft assembly to rotate, which
causes actuation of the end effector 12, as described above.
[0062] The ring 84 threaded on the helical gear drum 80 may include
a post 86 that is disposed within a slot 88 of a slotted arm 90.
The slotted arm 90 has an opening 92 its opposite end 94 that
receives a pivot pin 96 that is connected between the handle
exterior side pieces 59, 60. The pivot pin 96 is also disposed
through an opening 100 in the firing trigger 20 and an opening 102
in the middle handle piece 104.
[0063] In addition, the handle 6 may include a reverse motor switch
(or end-of-stroke switch) 130 and a stop motor (or
beginning-of-stroke) switch 142. In various embodiments, the
reverse motor switch 130 may be a limit switch located at the
distal end of the helical gear drum 80 such that the ring 84
threaded on the helical gear drum 80 contacts and trips the reverse
motor switch 130 when the ring 84 reaches the distal end of the
helical gear drum 80. The reverse motor switch 130, when activated,
sends a signal (i.e., permits current to flow) to the motor 65 to
reverse its rotation direction, thereby withdrawing the knife 32 of
the end effector 12 following the cutting operation.
[0064] The stop motor switch 142 may be, for example, a
normally-closed limit switch. In various embodiments, it may be
located at the proximate end of the helical gear drum 80 so that
the ring 84 trips the switch 142 when the ring 84 reaches the
proximate end of the helical gear drum 80.
[0065] In operation, when an operator of the instrument 10 applies
an actuation motion to the firing trigger 20, the run motor switch
110 detects the deployment of the firing trigger 20 and sends a
signal (i.e., permits current to flow) to the motor 65 to cause
forward rotation of the motor 65, for example, at a rate
proportional to how hard the operator pulls back the firing trigger
20. The forward rotation of the motor 65 in turn causes the ring
gear 78 at the distal end of the planetary gear assembly 72 to
rotate, thereby causing the helical gear drum 80 to rotate, causing
the ring 84 threaded on the helical gear drum 80 to travel distally
along the helical gear drum 80. The rotation of the helical gear
drum 80 also drives the main drive shaft assembly as described
above, which in turn causes deployment of the knife 32 in the end
effector 12. That is, the knife 32 and sled 33 are caused to
distally traverse the channel 22 longitudinally, thereby cutting
tissue clamped in the end effector 12. Also, the stapling operation
of the end effector 12 is caused to happen in embodiments where a
stapling-type end effector 12 is used.
[0066] By the time the cutting/stapling operation of the end
effector 12 is complete, the ring 84 on the helical gear drum 80
will have reached the distal end of the helical gear drum 80,
thereby causing the reverse motor switch 130 to be activated, which
sends a signal (i.e., permits current to flow) to the motor 65 to
cause the motor 65 to reverse its rotation. This in turn causes the
knife 32 to retract, and also causes the ring 84 on the helical
gear drum 80 to move back to the proximate end of the helical gear
drum 80.
[0067] The middle handle piece 104 includes a backside shoulder 106
that engages the slotted arm 90 as best shown in FIGS. 8 and 9. The
middle handle piece 104 also has a forward motion stop 107 that
engages the firing trigger 20. The movement of the slotted arm 90
is controlled, as explained above, by rotation of the motor 65.
When the slotted arm 90 rotates counter clockwise as the ring 84
travels from the proximate end of the helical gear drum 80 to the
distal end, the middle handle piece 104 will be free to rotate
counter clockwise. Thus, as the user draws in the firing trigger
20, the firing trigger 20 will engage the forward motion stop 107
of the middle handle piece 104, causing the middle handle piece 104
to rotate counter clockwise. Due to the backside shoulder 106
engaging the slotted arm 90, however, the middle handle piece 104
will only be able to rotate counter clockwise as far as the slotted
arm 90 permits. In that way, if the motor 65 should stop rotating
for some reason, the slotted arm 90 will stop rotating, and the
user will not be able to further draw in the firing trigger 20
because the middle handle piece 104 will not be free to rotate
counter clockwise due to the slotted arm 90.
[0068] FIGS. 10A and 10B illustrate two states of a variable
switches or sensors that may be used as the run motor switch 110
according to various embodiments of the present invention. The run
motor switch 110 may include a face portion 280, a first electrode
(A) 282, a second electrode (B) 284, and a compressible dielectric
material 286 between the electrodes 282, 284, such as, for example,
an electroactive polymer (EAP). The run motor switch 110 may be
positioned such that the face portion 280 contacts the firing
trigger 20 when retracted. Accordingly, when the firing trigger 20
is retracted, the dielectric material 286 is compressed, as shown
in FIG. 10B, such that the electrodes 282, 284 are closer together.
Since the distance "b" between the electrodes 282, 284 is directly
related to the impedance between the electrodes 282, 284, the
greater the distance the more impedance, and the closer the
distance the less impedance. In that way, the amount that the
dielectric 286 is compressed due to retraction of the firing
trigger 20 (denoted as force "F" in FIG. 10B) is proportional to
the impedance between the electrodes 282, 284, which can be used to
proportionally control the motor 65.
[0069] Components of an exemplary closure system for closing (or
clamping) the anvil 24 of the end effector 12 by retracting the
closure trigger 18 are also shown in FIGS. 7-10. In the illustrated
embodiment, the closure system includes a yoke 250 connected to the
closure trigger 18 by a pivot pin 251 inserted through aligned
openings in both the closure trigger 18 and the yoke 250. A pivot
pin 252, about which the closure trigger 18 pivots, is inserted
through another opening in the closure trigger 18 which is offset
from where the pin 251 is inserted through the closure trigger 18.
Thus, retraction of the closure trigger 18 causes the upper part of
the closure trigger 18, to which the yoke 250 is attached via the
pin 251, to rotate counterclockwise. The distal end of the yoke 250
is connected, via a pin 254, to a first closure bracket 256. The
first closure bracket 256 connects to a second closure bracket 258.
Collectively, the closure brackets 256, 258 define an opening in
which the proximate end of the proximate closure tube 40 (see FIG.
4) is seated and held such that longitudinal movement of the
closure brackets 256, 258 causes longitudinal motion by the
proximate closure tube 40. The instrument 10 also includes a
closure rod 260 disposed inside the proximate closure tube 40. The
closure rod 260 may include a window 261 into which a post 263 on
one of the handle exterior pieces, such as exterior lower side
piece 59 in the illustrated embodiment, is disposed to fixedly
connect the closure rod 260 to the handle 6. In that way, the
proximate closure tube 40 is capable of moving longitudinally
relative to the closure rod 260. The closure rod 260 may also
include a distal collar 267 that fits into a cavity 269 in
proximate spine tube 46 and is retained therein by a cap 271 (see
FIG. 4).
[0070] In operation, when the yoke 250 rotates due to retraction of
the closure trigger 18, the closure brackets 256, 258 cause the
proximate closure tube 40 to move distally (i.e., away from the
handle end of the instrument 10), which causes the distal closure
tube 42 to move distally, which causes the anvil 24 to rotate about
the pivot pins 25 into the clamped or closed position. When the
closure trigger 18 is unlocked from the locked position, the
proximate closure tube 40 is caused to slide proximately, which
causes the distal closure tube 42 to slide proximately, which, by
virtue of the tab 27 being inserted in the window 45 of the distal
closure tube 42, causes the anvil 24 to pivot about the pivot pins
25 into the open or unclamped position. In that way, by retracting
and locking the closure trigger 18, an operator may clamp tissue
between the anvil 24 and channel 22, and may unclamp the tissue
following the cutting/stapling operation by unlocking the closure
trigger 20 from the locked position.
[0071] FIG. 11 is a schematic diagram of a current control circuit
of the instrument 10 according to various embodiments of the
present invention. When an operator initially pulls in the firing
trigger 20 after locking the closure trigger 18, the run motor
switch 110 is activated, allowing current to flow therethrough. If
the normally-open reverse motor sensor switch 130 is open (meaning
the end of the end effector stroke has not been reached), current
will flow to a single pole, double throw relay 132. Since the
reverse motor sensor switch 130 is not closed, the inductor 134 of
the relay 132 will not be energized, so the relay 132 will be in
its non-energized state. The circuit also includes a cartridge
lockout switch 136. If the end effector 12 includes a staple
cartridge 34, the switch 136 will be in the closed state, allowing
current to flow. Otherwise, if the end effector 12 does not include
a staple cartridge 34, the switch 136 will be open, thereby
preventing the battery 64 from powering the motor 65.
[0072] When the staple cartridge 34 is present, the switch 136 is
closed, which energizes a single pole, single throw relay 138. When
the relay 138 is energized, current flows through the relay 136,
through the variable resistor (run motor) switch 110, and to the
motor 65 via a double pole, double throw relay 140, thereby
powering the motor 65 and allowing it to rotate in the forward
direction.
[0073] When the end effector 12 reaches the end of its stroke, the
reverse motor switch 130 will be activated, thereby closing the
reverse motor switch 130 and energizing the relay 134. This causes
the relay 134 to assume its energized state, which causes current
to bypass the cartridge lockout switch 136 and variable resistor
110, and instead causes current to flow to both the normally-closed
double pole, double throw relay 142 and back to the motor 65, but
in a manner, via the relay 140, that causes the motor 65 to reverse
its rotational direction.
[0074] Because the stop motor switch 142 is normally-closed,
current will flow back to the relay 134 to keep it closed until the
stop motor switch 142 opens. When the knife 32 is fully retracted,
the stop motor switch 142 is activated, causing the stop motor
switch 142 to open, thereby removing power from the motor 65.
[0075] In other embodiments, rather than a proportional-type switch
110, an on-off type sensor or switch could be used. In such
embodiments, the rate of rotation of the motor 65 would not be
proportional to the force applied by the operator. Rather, the
motor 65 would generally rotate at a constant rate. But the
operator would still experience force feedback because the firing
trigger 20 is geared into the gear drive train.
[0076] As indicated above, there are several steps within the
function of a stapler that generally must be accomplished in an
established order. For example, once the closure trigger is
clamped, the firing cycle may be actuated. After the knife has been
fully deployed, then retraction of the system is the next
sequential step. With the inclusion of a power source other than
the user (i.e. batteries or pneumatics) the ability to reduce user
initiated steps (and therefore device complexity) the system
itself, as was discussed above, can begin to accomplish these steps
itself.
[0077] It may be desirable, however, for the user to intuitively be
able to delay, slow or stop these otherwise "automatic" actuations.
For example, the same actuation button that would allow for firing
initiation in a tactile feedback device like the devices disclosed
in U.S. patent application Ser. No. 11/344,035, now U.S. Pat. No.
7,422,139, the disclosure of which is herein incorporated by
reference in its entirety could be used to slow or stop an
automatic return system by the user depressing the button during
the retraction.
[0078] For example, FIGS. 12 and 13 illustrate another embodiment
of the present invention wherein a retraction trigger 121 is
supported on the firing trigger 20 for travel therewith. More
specifically, the retraction trigger 121 is pivotally supported on
firing trigger pin 96 and protrudes through a slot (not shown) in
the firing trigger 20. A spring 125 is attached between a coupling
portion 123 of the firing trigger 100 and a mounting portion 127 of
the retraction trigger 121 to bias the retraction trigger 121 into
an unactuated position. A second, normally-closed, retraction
switch 131 is mounted within the handle and is oriented such that,
as the firing trigger 20 is moved between a fully actuated position
to a fully unactuated position, an activation portion 129 of the
retraction trigger 121 does not activate the retraction switch 131.
However, the mounting portion 127 and activation portion 129 of the
retraction trigger 121 are so configured such that the activation
portion 129 may be brought into activation contact with the
retraction switch 131 by depressing the retraction trigger 121
towards the firing trigger 20 regardless of where the firing
trigger 20 is located during the retraction process.
[0079] As was discussed above, when the end effector 12 reaches the
end of its stroke, the end of stroke switch 130 will be activated.
As shown in the example of FIG. 13, the retraction switch 131 is in
series with the end-of-stroke switch 130. Because the retraction
switch 131 is normally closed, relay 134 will be energized when
both switches 130, 131 are closed. This causes the relay 134 to
assume its energized state, which causes current to bypass the
cartridge lockout sensor 136 and variable resistor 110. Current to
flows to the double pole, double throw relay 140 and to the motor
65, but in a manner, via the relay 140, that causes the motor 65 to
reverse its rotational direction. Because the beginning-of-stroke
switch 142 is closed, current will flow back to the relay 134 to
keep it closed until the switch 142 opens. When the knife 32 is
fully retracted, the beginning-of-stroke switch 142 is opened,
thereby removing power from the motor 65. If, however, the user
wants to slow down the retraction process, the user may depress the
retraction trigger 121 to activate the variable resistance portion
133 of the retraction switch 131. When the retraction trigger 121
is not depressed, the resistance of the variable resistance portion
133 is a minimum. When the trigger 121 is depressed, the resistance
of the variable resistance portion 133 increases in proportion to
the depressing force of the retraction trigger 121 to reduce the
current to the motor 65. Further depression of the retraction
trigger 121 will slow the retraction process until the normally
closed contact 135 portion of the retraction switch 131 opens and
stops the current flow to the motor 65. In various embodiments,
once the user releases the retraction trigger 121, the spring 125
will move the retraction trigger 121 to an unactuated position and
the contact portion 135 of switch 131 will return to the normally
closed position and thereby permit current to flow again to the
motor 65 to complete the retraction process.
[0080] The unique and novel features of the retraction switch and
retraction trigger arrangements described above may also be
employed in connection with the various embodiments disclosed in
U.S. Patent Application Publication No. US 2010/007674 A1, and U.S.
Pat. No. 7,422,139 which have both been herein incorporated by
reference in their respective entireties. For example, FIG. 14
shows another embodiment of a current control circuit embodiment of
the present invention. When (i) the run motor (or fire) switch 110
is closed (it is shown in an open state in FIG. 14), (ii) the
safety switch 240 is closed (it is shown open in FIG. 14)
indicating that the device safety is set, and (iii) the
normally-closed lockout switch 242 is opened indicating that the
instrument is not in a lock-out condition, current flows through
the safety switch 240, through the lockout indicator 244 (which may
be a LED as shown in FIG. 14) to the motor 65. When the end of the
cutting stroke is reached, the end-of-stroke or direction switch
130 is switched, reversing the direction of the motor 65 (with the
fire switch 110 also having been released). In this state, current
also flows through a reverse direction indicator 246, such as an
LED, providing a visual indication that the motor direction has
been reversed.
[0081] As shown in FIG. 14, the circuit may also comprise a manual
return switch 248. The operator may manually actuate this switch if
the cutting instrument 32 has only been partially fired. Switching
the manual return switch 248 causes the motor 65 to reverse rotate,
causing the cutting instrument 32 to return to its original or home
position. If, the user desires to slow down or stop the retraction
process, the user depresses the retraction trigger 121 to activate
the variable resistance portion 133 of the retraction switch 131.
When the trigger 121 is depressed, the resistance increases in
portion to the depressing force to reduce the current to the motor
65. Further depression of the retraction trigger 121 will slow the
retraction process until the normally closed contact 135 portion of
the retraction switch 131 opens and stops the current flow to the
motor 65. In various embodiments, once the user releases the
retraction trigger 121, the spring 125 will move the retraction
trigger 121 to an unactuated position and the contact portion 135
of switch 131 will return to the normally closed position and
thereby permit current to flow again to the motor 65 to complete
the retraction process.
[0082] Additional configurations for motorized surgical instruments
are disclosed in published U.S. Patent Application Publication No.
US 2010/0076474 A1, entitled "Motor-Driven Surgical Cutting
Instrument," which is incorporated herein by reference in its
entirety. For example, FIG. 15 is a schematic diagram of another
current control circuit according to various embodiments of the
present invention. In various embodiments, the motor control
circuit may include one of more integrated circuits (ICs), such as,
for example, a processor, memory, microcontroller, time circuits,
etc. In other embodiments, the motor control circuit may not
comprise any ICs. Such a non-IC current control circuit may be
advantageous because it is often difficult, complicated, and
expensive to sterilize a surgical instrument including ICs.
[0083] When an operator initially applies an actuation motion to
the firing trigger 20 after locking the closure trigger 18, the run
motor switch 110 is activated (or closed), allowing current to flow
therethrough. If the normally open reverse motor sensor switch 130
is open (meaning the end of the end effector stroke has not been
reached), current will flow to a single pole, double throw relay
132. When the reverse motor sensor switch 130 is not closed, a coil
134 of the relay 132 will not be energized, so the relay 132 will
be in its de-energized state.
[0084] As shown in FIG. 15, the circuit may also include a
resistive element 144 and a switch 146 connected in parallel, with
the paralleled elements connected in series with the relay 132. The
resistive element 144 and the switch 146 are also connected to the
power source 64. The switch 146 may be controlled by a control
circuit 148 that is responsive to the cutting instrument position
sensor 150. According to various embodiments, the control circuit
148 may open the switch 146 when the cutting instrument 32 is (i)
very near to the beginning of its stroke and (ii) very near to the
end of its stroke. For example, the control circuit may open the
switch when the cutting instrument 32 is (i) 0.001 inches from the
beginning point of its stroke and (ii) 0.001 inches from the end of
its stroke, as determined by the cutting instrument position sensor
150. With the switch 146 open, current flows through the resistive
element 144, and then through the relay 132, the relay 138, the run
motor sensor switch 110, to the motor 65. Current flowing through
the resistive element 144 reduces the magnitude of the current
delivered to the motor 65, thereby reducing the power delivered by
the motor 65. Thus, when the cutting instrument 32 is (i) very near
to the beginning of its stroke or (ii) very near to the end of its
stroke, the power delivered by the motor 65 is reduced. Conversely,
once the cutting instrument 32 moves sufficiently far from its
beginning point or end of stroke point, the control circuit 148 may
close the switch 146, thereby shorting the resistive element 144,
thereby increasing the current to the motor 65, thereby increasing
the power delivered by the motor.
[0085] According to various embodiments, the current control
circuit further includes lockout sensor switches 136a-d
collectively defining an interlock circuit 137 through which
current from the relay 132, when de-energized, passes in order for
electrical operation of the motor 65 to be initiated. Each lockout
sensor switch 136a-d may be configured to maintain an open (i.e.,
non-conductive) switch state or a closed (i.e., conductive) switch
state responsive to the presence or absence, respectively, of a
corresponding condition. Any of the corresponding conditions, if
present when the instrument 10 is fired, may result in an
unsatisfactory cutting and stapling operation and/or damage to the
instrument 10. Conditions to which the lockout sensor switches
136a-d may respond include, for example, (a) the absence of the
staple cartridge 34 in the channel 22, (b) the presence of a spent
(e.g., previously fired) staple cartridge 34 in the channel 22, and
(c) an open (or otherwise insufficiently closed) position of the
anvil 24 with respect to the channel 22. Other conditions to which
the lockout sensor switches 136a-d may respond, such as component
wear, may be inferred based upon an accumulated number of firing
operations produced by the instrument 10. Accordingly, in various
embodiments, if any of these conditions exists, the corresponding
lockout sensor switches 136a-d maintain an open switch state, thus
preventing passage of the current necessary to initiate operation
of the motor 65. Passage of current by the lockout sensors 136a-d
is allowed, in various embodiments, only after all of the
conditions have been remedied. It will be appreciated that the
above-described conditions are provided by way of example only, and
that additional lockout sensor switches for responding to other
conditions detrimental to operation of the instrument 10 may be
provided. It will similarly be appreciated that for embodiments in
which one or more of the above-described conditions may not exist
or are of no concern, the number of lockout sensor switches may be
fewer than that depicted.
[0086] As shown in FIG. 15, the lockout sensor switch 136a may be
implemented using a normally open switch configuration such that a
closed switch state is maintained when the staple cartridge 34 is
in a position corresponding to its proper receipt by the channel
22. When the staple cartridge 34 is not installed in the channel
22, or is installed improperly (e.g., mis-aligned), the lockout
sensor switch 136a maintains an open switch state. Lockout sensor
switch 136b may be implemented using a normally open switch
configuration such that a closed switch state is maintained only
when an unspent staple cartridge 34 (i.e., a staple cartridge 34
having a sled 33 in the unfired position) is present in the channel
22. The presence of a spent staple cartridge 34 in the channel 22
causes the lockout sensor switch 136b to maintain an open switch
state. Lockout sensor switch 136c may be implemented using a
normally open switch configuration such that a closed switch state
is maintained when the anvil 24 is in a closed position with
respect to the channel 22. The lockout sensor switch 136c may be
controlled in accordance with a time delay feature wherein a closed
switch state is maintained only after the anvil 24 is in the closed
position for a pre-determined period of time.
[0087] Lockout sensor switch 136d may be implemented using a
normally closed switch configuration such that a closed switch
state is maintained only when an accumulated number of firings
produced by the instrument 10 is less than a pre-determined number.
The lockout sensor switch 136d may be in communication with a
counter 139 configured for maintaining a count representative of
the accumulated number of firing operations performed by the
instrument 10, comparing the count to the pre-determined number,
and controlling the switch state of the lockout sensor switch 136d
based upon the comparison. Although shown separately in FIG. 15, it
will be appreciated that counter 139 may be integral with the
lockout sensor switch 136d so as to form a common device.
Preferably, the counter 139 is implemented as an electronic device
having an input for incrementing the maintained count based upon
the transition of a discrete electrical signal provided thereto. It
will be appreciated that a mechanical counter configured for
maintaining the count based upon a mechanical input (e.g.,
retraction of the firing trigger 20) may be used instead. When
implemented as an electronic device, any discrete signal present in
the electrical circuit that transitions once for each firing
operation may be utilized for the counter 139 input. As shown in
FIG. 15, for example, the discrete electrical signal resulting from
actuation of the end-of-stroke sensor 130 may be utilized. The
counter 139 may control the switch state of lockout sensor switch
136d such that a closed switch state is maintained when the
maintained count is less than a pre-determined number stored within
the counter 139. When the maintained count is equal to the
pre-determined number, the counter 139 causes the lockout sensor
switch 136d to maintain an open switch state, thus preventing the
passage of current therethrough. It will be appreciated that the
pre-determined number stored by the counter 139 may be selectively
adjusted as required. According to various embodiments, the counter
304 may be in communication with an external display (not shown),
such as an LCD display, integral to the instrument 10 for
indicating to a user either the maintained count or the difference
between the pre-determined number and the maintained count.
[0088] According to various embodiments, the interlock circuit 137
may comprise one or more indicators visible to the user of the
instrument 10 for displaying a status of at least one of the
lockout sensor switches 136a-d. More details regarding such
indicators may be found in published U.S. Patent Application
Publication No. 2007/0175956, entitled "Electronic Lockouts and
Surgical Instrument Including Same," which is incorporated herein
by reference in its entirety. This application also includes
example mounting arrangements and configurations for the lockout
sensor switches 136a-d.
[0089] In the illustrated embodiment, when the lockout sensor
switches 136a-d collectively maintain a closed switch state, a
single pole, single throw relay 138 is energized. When the relay
138 is energized, current flows through the relay 138, through the
run motor switch sensor 110, and to the motor 65 via a double pole,
double throw relay 140, thereby powering the motor 65, allowing it
to rotate in the forward direction. According to various
embodiments, because the output of the relay 138, once energized,
maintains the relay 138 in an energized state until relay 132 is
energized, the interlock circuit 137 will not function to prevent
operation of the motor 165 once initiated, even if one or more of
the interlock sensor switches 136a-d subsequently maintains an open
switch state. In other embodiments, however, it may be necessary or
otherwise desirable to connect the interlock circuit 137 and the
relay 138 such that one or more the lockout sensor switches 136a-d
must maintain a closed switch state in order to sustain operation
of the motor 165 once initiated.
[0090] Rotation of the motor in the forward direction causes the
ring to move distally and thereby de-actuate the stop motor sensor
switch 142 in various embodiments. Because the switch 142 is
normally closed, a solenoid 141 connected to the switch 142 may be
energized. The solenoid 141 may be a conventional push-type
solenoid that, when energized, causes a plunger (not shown) to be
axially extended. Extension of the plunger may operate to retain
the closure trigger 18 in the retracted position, thus preventing
the anvil 24 from opening while a firing operation is in progress
(i.e., while the switch 142 is not actuated). Upon de-energization
of the solenoid 141, the plunger is retracted such that manual
release of the closure trigger 18 is possible.
[0091] When the actuation member portion reaches the distal most
end of its stroke, the reverse motor switch 130 will be activated,
thereby closing the switch 130 and energizing the relay 132. This
causes the relay 132 to assume its energized state (not shown in
FIG. 11), which causes current to bypass the interlock circuit 137
and run motor sensor switch 110, and instead causes current to flow
to both the normally-closed double pole, double throw relay 140 and
back to the motor 65, but in a manner, via the relay 140, that
causes the motor 65 to reverse its rotational direction. Because
the stop motor sensor switch 142 is normally closed, current will
flow back to the relay 132 to keep it energized until the switch
142 opens. When the knife 32 is fully retracted, the stop motor
sensor switch 142 is activated, causing the switch 142 to open,
thereby removing power from the motor 65, and de-energizing the
solenoid 141.
[0092] In the embodiment depicted in FIG. 15, a normally closed
retraction switch 137 is employed which interfaces with retraction
trigger 121 (not shown in FIG. 15). When retraction switch 137 is
activated, it opens to stop the flow of current to the motor 65. In
alternative embodiments (FIG. 15A), the normally closed retraction
switch 137 could be replaced with a variable resistor 137' that
interfaces with retraction trigger 121. In such embodiment, when
the retraction trigger 121 is not depressed, the resistance of the
variable resistor is minimal to allow maximum current to flow to
the motor 65. When depressed the resistance increases in proportion
to the depressing force to reduce current to the motor. Such
variable resistor may also be replaced with the retraction switch
131 as described above (see FIG. 15B).
[0093] Accidental actuation prevention for a powered endocutter:
With the introduction of powered systems that no longer limit the
device function to the force capabilities of the user, inadvertent
initiation of the firing cycle may become a much more prevalent
issue. It will be increasing ease to "bump" the activation control
and have the instrument begin firing thereby tripping the lockout
of the cartridge or even "jamming" it on tissue, as the user is
unaware it has already begun firing. Various lockout arrangements
are disclosed in U.S. Pat. No. 7,644,848, entitled "Electronic
Lockouts and Surgical Instrument Including Same" to Swayze et al.,
the disclosure of which is herein incorporated by reference in its
entirety. To eliminate this issue secondary unlock activator
switches or buttons could be used to unlock the firing mechanism.
This is much the same as the two switch systems used in the power
saw industry as well as the military to protect against accidental
actuation. The secondary switch can either release the lock on the
firing trigger or merely energize the power to the control.
[0094] As mentioned above, in using a two-stroke motorized
instrument, the operator first pulls back and locks the closure
trigger 18. FIGS. 16 and 17 show one embodiment of a way to lock
the closure trigger 18 to the pistol grip portion 26 of the handle
6. In the illustrated embodiment, the pistol grip portion 26
includes a hook 150 that is biased to rotate CCW about a pivot
point 151 by a torsion spring 152. Also, the closure trigger 18
includes a closure bar 154. As the operator draws in the closure
trigger 18, the closure bar 154 engages a sloped portion 156 of the
hook 150, thereby rotating the hook 150 upward (or CW in FIGS. 16
and 17) until the closure bar 154 completely passes the sloped
portion 156 passes into a recessed notch 158 of the hook 150, which
locks the closure trigger 18 in place. The operator may release the
closure trigger 18 by pushing down on a slide button release 160 on
the back or opposite side of the pistol grip portion 26. Pushing
down the slide button release 160 rotates the hook 150 CW such that
the closure bar 154 is released from the recessed notch 158. Other
arrangements for releasably locking the closure trigger 18 are
disclosed in U.S. Pat. No. 7,422,139 which has been herein
incorporated by reference.
[0095] As can be seen in FIGS. 16 and 17, in various embodiments, a
closure lock switch 151 may be mounted in the hook 150 such that
that is activated only when the hook 150 is latched in place.
However, the closure lock switch 151 may be mounted in the pistol
grip portion 26 for activation by the closure trigger 18 when the
closure trigger 18 is locked in position. In still other
alternative embodiments, the closure lock switch 151 is mounted to
the end effector such that it is activated only when the anvil or
other movable portion is in the "closed" position. Regardless of
the specific location of the closure lock switch 151, in various
embodiments, the closure lock switch is a normally open switch that
will be closed upon locking of the closure trigger 18 or otherwise
manipulating the end effector to a "closed" position.
[0096] FIG. 18 is a schematic diagram of an electrical circuit of
the instrument 10 according to various embodiments of the present
invention illustrating the use of the closure lock switch 151. As
can be seen in that Figure, current will not be permitted to flow
from the battery 64 to the motor 65 even if a cartridge is present
unless the closure lock switch 151 is closed. Thus, the motor 65
cannot be operated unless the closure trigger is in the locked
closed position which also reflects that the end effector is in the
closed state.
[0097] Various embodiments may further include a start switch 153
that must be activated by the surgeon before current will be
permitted to flow from the battery 64 to the other circuit
components and ultimately to the motor 65. Start switch 153 is
normally open and may be located at a convenient location on the
handle 6. See FIG. 1. Thus, in these embodiments, even if the end
effector contains a cartridge and the closure trigger 18 is locked
in a closed position, current will not be permitted to flow to the
motor 65 until the start switch 153 is closed by the surgeon. In
alternative embodiments, the start switch 153 may comprise a
mechanical switch that prevents the firing trigger 20 from being
physically rotated toward the pistol grip portion unless the switch
153 is moved to an actuated position.
[0098] Active adjustable staple height for a powered endocutter:
Staple height that is adjustable to the tissue thickness and type
has been pursued for many years. Most recently, U.S. patent
application Ser. No. 11/231,456, filed Sep. 21, 2005, now U.S. Pat.
No. 7,407,078 and U.S. patent application Ser. No. 11/540,735,
filed Sep. 29, 2006, now U.S. Pat. No. 7,467,740, the disclosures
of which are each hereby incorporated by reference in their
respective entireties generally involve a flexible coupling member
or supports that would allow the gap of the instrument to enlarge
with loads induced by thicker tissue in the device. This "passive"
variable staple height allows the thickness of the tissue to create
larger staple forms.
[0099] With the introduction of a power source within the
instrument this allows for the use of electricity to change the
height of an internal element within the dynamic coupling element
with would change the height of the staple "actively" by the
surgeon or instrument setting the desired height. This internal
element could be a shape memory material and the electricity
changes its temperature and therefore allows it to change its
physical height due to preset configuration. Another viable method
would be the inclusion of an electro-active polymer (EAP) that
through the introduction of an electric field allows it to change
its height and width. Yet a third embodiment would be to utilize a
traditional linear electrical stepper element that can ratchet a
small adjustable screw element within the coupling beam that would
adjust its height.
[0100] More specifically and with reference to FIGS. 19 and 20, an
end effector 12 of various embodiments of the present invention is
shown in cross-section with the anvil 24 in a closed or clamped
position. As can be seen, the cutting instrument or knife 32 has a
lower actuator portion 37 that has a threaded sleeve or nut portion
37' that is configured to threadably engage the helical screw shaft
36. In addition, a fin 39 protrudes laterally from each lateral
side of the nut portion 37 to confront corresponding slide portions
23 of the channel 22. As can also be seen in FIG. 19, the knife 32
has an upper actuator portion 41 that is sized to be received
within a longitudinal T-shaped slot 43 in the anvil 24. As can be
seen in FIG. 19, a pair of upper retainer pins 41' protrude
laterally from each side of the upper actuator portion 41 of the
knife 32. Each upper retainer pin 41' is configured to extend into
a corresponding portion of the T-shaped slot 43 provided in the
anvil 24. Thus, as the knife 32 is driven distally through the end
effector 12, the fins 39 and the retainer pins 41' serve to limit
the amount of space between the anvil 24 and the cartridge 34 to a
maximum amount of predetermined space.
[0101] Various embodiments of the present invention are provided
with means for adjusting the amount of space between the anvil 24
and the cartridge 34 installed within the channel 22. For example,
in some embodiments, each fin 39 supports a sled contact 45 for
sliding contact with corresponding electrical contacts 47 that are
mounted within each slide portion 23 of the channel 22. The
electrical contacts 47 are elongated and extend within the channel
22 so that the sled contacts 45 are always on contact with their
corresponding electrical contact 47 as the knife 32 is driven
within the channel 22. Electrical contacts 47 are connected to the
power source or battery 64 and are configured to receive current
therefrom when the motor 65 is powered to drive the knife 32
distally. Also in certain embodiments, an electrically responsive
height adjustment member 49 is mounted to each retainer pin 41' as
shown in FIG. 19. The height adjustment members 49 are electrically
coupled to the sled contacts 45 to receive electrical current
therefrom. In various embodiments, the height adjustment members 49
may comprise shape memory material that, when electrified, changes
its physical height due to a preset configuration. Thus, depending
upon the amount of current received, the height adjust member
members 49 may expand and force the anvil 24 towards the cartridge
34 to thereby reduce the amount of space therebetween. The amount
that such material is proportional to the amount of current
received and is known. A control circuit (not shown) may be
employed to control the amount of expansion and hence the amount of
space between the anvil 24 and the cartridge 34. In other
embodiments, the height adjustment material comprises an
electro-active polymer (EAP) that is retained within a pocket in
the pin 41 or is otherwise attached thereto.
[0102] FIG. 21 illustrates another embodiment that is similar to
the embodiment depicted in FIG. 19. However, in this embodiment,
the height adjustment members 49 are mounted in the anvil 24 and
receive current from the power source through conductors attached
directly thereto. Thus, in this embodiment, the contacts 43 and 45
as described above are not needed.
[0103] FIG. 22 illustrates an alternative knife assembly 32' that
is substantially identical to the knife assembly 32 described
above, except that the retainer pins 41' are mounted to a separate
upper actuator portion 302 that is selectively movable in a
vertical direction "VD" relative to a lower portion 300 of the
knife assembly 32'. A second motor 304 may be mounted to the lower
portion 300 and have a lead screw 306 that threadably engages a nut
portion 308 of the upper retainer portion 302. The upper retainer
portion has a "T"-shaped tongue portion 310 that slidably extends
into a correspondingly shaped slot 312 in the lower portion 300 to
prevent rotation of the upper retainer portion 302 relative to the
lower retainer portion 300 while permitting the upper retainer
portion 302 to move vertically relative thereto. Thus, the distance
between the upper and lower retainer portions 302, 300 may be
adjusted by powering the second motor 304. Accordingly, if the
surgeon wants to reduce the amount of space between the anvil 24
and the cartridge 34, second motor 304 is powered to rotate in a
first direction to draw the upper retainer portion 302 towards the
lower retainer portion 300. If however, the surgeon desires to
increase the amount of space between the anvil 24 and the cartridge
34, the second motor 304 is rotated in an opposite direction.
[0104] Various embodiments of the present invention include
end-effector illumination methods and methods for illuminating the
surgical site when employing a powered endocutter. Currently when
the end-effector is in or near its deployment position it is
sometimes difficult for the surgeon to visualize the treatment site
as there are shadows cast by adjacent structures as well as the
end-effector may even be behind another structure entirely. FIG. 23
illustrates in general form, a distal end 402 of a surgical stapler
400 of various embodiments of the present invention which includes
an anvil 404, a cartridge body 406, and channel 408. As seen from
that Figure, an additional light source 410 may be positioned on
the end of the cartridge body 406 to illuminate tissue 401. This
light source 410 could be any combination of practical means that
convert electrical energy to light including but not limited to
semiconductor (such as LED), a conventional incandescent or
filament bulb, electroluminescent or laser that may be powered from
a battery supported in the instrument handle or in other
embodiments, powered by alternating current. Such arrangements
would allow the surgeon to not only light up the treatment site
directly, they could allow for backlighting of structures to see
the internal components like vasculature and facilitate the use of
a laser pointer through a traditional scope to point out areas of
interest to others.
[0105] In various embodiments, one or more contacts 420 are
provided on the back of the cartridge body 406 that are configured
to engage contacts 422 within the channel 408. See FIG. 24. This
would allow the surgeon to energize the light 410 as needed by
energizing contact set via a switch positioned on the handle 430.
This switch could even have variable intensity as the one described
in could control the actuation speed of the main, device. Other
lighting arrangements for lighting the end of an anvil attached to
a circular surgical stapler are disclosed in U.S. Patent
Application Publication No. US 2010/0096435 A1, entitled "Surgical
Stapling Instrument With Apparatus For Providing Anvil Position
Feedback", Published Apr. 22, 2010, the entire disclosure of which
is hereby incorporated by reference.
[0106] U.S. Patent Application Publication No. 2007/0175949 A1,
entitled "Surgical Instrument Having a Feedback System", Published
Aug. 2, 2007, the entire disclosure of which is hereby incorporated
by reference, further discloses in FIGS. 45-47 of that Publication
output displays that could show among other this position feedback
of the end-effector, lockout status, number of firings etc. This
would minimize one of the more difficult issues for the user, which
is the identification of the status of a device, especially the
lockout status of the device without actuating the device. An
additional feedback that would be helpful for the user would be
immediate feedback as to the status of the cartridge when it is
loaded. As in the above application it could be rolled up into the
lockout indication on the handle 430. An indicator 432 (such as an
LED, glass bulb, LCD, sonic enunciator, vibrator, etc.) could
solely be associated with the status of a cartridge lockout means
or mechanism such that it providing this information to the
surgeon. This LED could be located on the handle 430. See FIG. 26.
Alternatively an indicator 434 could be located near the distal end
402 which would provide immediate information to the surgeon and
loader if the cartridge is "good to go" or not. See FIG. 25. This
can be accomplished with a switch or set of contacts associated
directly with the mechanical lockout. The switch or contacts
complete a circuit such that the indicator provides appropriate
information. This completed contact set could be through a
conductive element within the sled (part 33 in U.S. Patent
Application Publication No. US 2007/0175958) and the two contacts
could be in the proximal position of the channel (part 22). Another
way to detect lockout status is indirectly through instrument
status (example I: loaded cartridge and no attempt to fire would
indicate lockout is not engaged; example 2: fired instrument and no
new cartridge installed would indicate lockout is engaged; etc.).
Another embodiment would be to place the LED or visual indication
cue on the cartridge itself. When the cartridge is snapped into
place it creates a contact that supplies the cartridge with power.
Should the cartridge be fired not only does the mechanical lockout
stop the advancement of the knife the cartridge circuit light up
the LED on the cartridge informing the surgeon on the scope monitor
that the cartridge is locked out. This could be further expanded by
placing a small battery or other charge accumulator within the
cartridge itself to eliminate the need for a power connection to
the main device. Also the cartridge circuit could be set to light
the lockout light whenever the device is closed to inform the user
there is a spent cartridge in the device.
[0107] Indication feedback for powered articulation and cartridge
color: Indicating the type of cartridge installed (color) and angle
of articulation is considered useful to the surgeon. The indication
of articulation angle could be indicated in several ways including
numerically or graphically as in an arc of LEDs. The location of
this indication could be on the handle in a convenient location or
on the shaft of the device just proximal to the end-effector. The
end-effector feedback could be passive or active. The active would
light up additional LEDs to show the angle. The passive could just
show a half pie lighted up so the surgeon could intuit how
articulated the end-effector is. As we further explore the surgical
procedures it becomes more and more obvious that the surgeon's eyes
need to be on the surgical site not on the handle of the
instrument. We also begin to understand the surgeon's need for
complete status feedback from the device. Articulation angle could
be illuminated as part of the articulation joint itself. With
lights, LEDs, etc. denoting the differing angle or even a small LCD
denoting angle in degrees. This would allow the surgeon to have
some feedback on the angle off of straight so he/she can easily
navigate back to this angle after removal and reinsertion. Another
issue is "obvious" indication of what color cartridge is in the
device. This can be accomplished by a color coded light array on
either the end-effector or the cartridge. This information could
also be transmitted back to the handle to display a "redundant"
display to assure there is minimal confusion as to what cartridge
is in the jaws. Another improvement could include a small leaf
spring contact connected to the proximal deck of the cartridge that
indicates if a minimum tissue pressure has been achieved within the
jaws. This minimum pressure would at the very least indicate if a
thick tissue cartridge is being used in thin tissue applications,
as it would not light if insufficient tissue pressure on the deck
were present.
[0108] There is a possible need of a method for the introduction of
non-sterile battery packs (possibly with the electronics integral
to the battery pack if programmable logic becomes a key customer
need). A patent already exists within the orthopedic drill industry
for the insertion of a non-sterile battery pack within a separately
sterilized re-useable device. This innovation is intended to
improve that concept by utilizing the disposable device sterile
packaging to protect the sterility of the instrument during the
insertion of the non-sterile battery pack. A further improvement
would be the inclusion of a "hatch" door designed within the
instrument and closable after the pack has been inserted but before
the device is removed from the final sterile packaging. This hatch
would then "contain" the non-sterile battery that could contaminate
the sterile surgical field. The method here would be to include an
additional layer of packaging that would have a perforated area
that the battery could be pushed through, either rupturing the
extra layer and allowing the battery through or going with the
electrode set of the battery only to be ruptured by the exposable
pin tips of the battery at complete insertion. An alternative of
this would be to have the internal terminals of the gun (deep
inside the battery protection cavity) rupture the sterile barrier
and seat within pinholes in the battery pack. The hatch could then
be closed through the sterile pack sealing the system. The gun
could then be handed into the sterile field normally as any sterile
device could.
[0109] Position Locator Embodiments I Linear encoder and load
control of motor parameters: U.S. Pat. Nos. 6,646,307 and 6,716,223
disclose the mechanisms for the measurement of rotation and related
torque to control motor parameters and optimizing of those
parameters based on identification of end-effector configurations
and loading. U.S. Patent Application Publication No. 2007/0175958
shows a method through the use of a threaded length of the primary
shaft in FIGS. 8-13 how this type of linear motion control could be
used to control the trigger location. The same type of method could
be used for electronic linear control methods. The end-effector
could identify its length and type mechanically by depressing at
least one spring biased plunger, which could identify to the handle
the type, and length it would allow the motor to run. The motor
rotation could be converted from rotary motion to linear rack or
cable motion, which could then be used to adjust motor voltage,
current, and speed to affect the desired linear motion of the
control slide. The control slide could then be directly coupled to
the knife drive motion. This control slide could have discrete or
continuous "stop" locations that the plunger identifier marks as
the max "go to" linear displacement before retraction
[0110] Identification of modular reloads with linear drive: A
useful feature for a surgical instrument is the ability to identify
which end-effector has been attached to the instrument. In the case
of a powered surgical stapler, several different types of
end-effectors could be attached. Additionally, a type of
end-effector may have at least one function and/or feature that is
selectively utilized or enabled. Disclosed are means for
identifying which end-effector is attached. Note that the "type" of
end-effector referenced below is not limited to mechanical,
pneumatic or hydraulically coupled end-effectors. The instrument
may take different actions, adjust operating parameters, indicate
available functions etc. as a result of detecting this end
effector.
[0111] The end-effector has an electrical connection that is made
when it is attached to the instrument. The instrument communicates
with the end-effector and reads at least one of several types of
signals. A switch position or contact position indicates which type
of end-effector is present. A passive element is measured for
impedance and the result indicates which type of end-effector is
present.
[0112] The end-effector has a radio frequency link to the
instrument and data is transferred in at least one direction
between the end-effector and the instrument.
[0113] The end-effector has an acoustic link to the instrument and
data is transferred in at least one direction between the
end-effector and the instrument.
[0114] The end-effector has an optical link to the instrument and
data is transferred in at least one direction between the
end-effector and the instrument.
[0115] The end-effector has mechanical link that engages elements
(such as switches or contacts) in the instrument that identify it
and thereby data is transferred in at least one direction between
the end-effector and the instrument.
[0116] While the present invention has been illustrated by
description of several embodiments and while the illustrative
embodiments have been described in considerable detail, it is not
the intention of the applicant to restrict or in any way limit the
scope of the appended claims to such detail. Additional advantages
and modifications may readily appear to those skilled in the
art.
[0117] For example, although the embodiments described above have
advantages for an endoscopically employed surgical severing and
stapling instrument 10, a similar embodiments may be used in other
clinical procedures. It is generally accepted that endoscopic
procedures are more common than laparoscopic procedures.
Accordingly, the present invention has been discussed in terms of
endoscopic procedures and apparatus. However, use herein of terms
such as "endoscopic", should not be construed to limit the present
invention to a surgical instrument for use only in conjunction with
an endoscopic tube (i.e., trocar). On the contrary, it is believed
that the present invention may find use in any procedure where
access is limited to a small incision, including but not limited to
laparoscopic procedures, as well as open procedures.
[0118] Any patent, publication, or information, in whole or in
part, that is said to be incorporated by reference herein is
incorporated herein only to the extent that the incorporated
material does not conflict with existing definitions, statements,
or other disclosure material set forth in this document. As such
the disclosure as explicitly set forth herein supersedes any
conflicting material incorporated herein by reference.
[0119] While this invention has been described as having exemplary
designs, the present invention may be further modified within the
spirit and scope of the disclosure. This application is therefore
intended to cover any variations, uses, or adaptations of the
invention using its general principles. Further, this application
is intended to cover such departures from the present disclosure as
come within known or customary practice in the art to which this
invention pertains.
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