U.S. patent application number 12/693460 was filed with the patent office on 2011-02-03 for driven surgical stapler improvements.
Invention is credited to Steven G. Hall.
Application Number | 20110024477 12/693460 |
Document ID | / |
Family ID | 42231783 |
Filed Date | 2011-02-03 |
United States Patent
Application |
20110024477 |
Kind Code |
A1 |
Hall; Steven G. |
February 3, 2011 |
Driven Surgical Stapler Improvements
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) |
Correspondence
Address: |
PHILIP S. JOHNSON;JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK
NJ
08933-7003
US
|
Family ID: |
42231783 |
Appl. No.: |
12/693460 |
Filed: |
January 26, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61150382 |
Feb 6, 2009 |
|
|
|
Current U.S.
Class: |
227/175.2 |
Current CPC
Class: |
A61B 2017/00199
20130101; A61B 2090/0811 20160201; A61B 2017/00221 20130101; A61B
2017/00685 20130101; A61B 2017/00734 20130101; A61B 2017/00402
20130101; A61B 2090/064 20160201; A61B 2017/00017 20130101; A61B
2017/07285 20130101; A61B 2017/00398 20130101; A61B 2017/07214
20130101; A61B 17/068 20130101; A61B 17/07207 20130101; A61B 34/71
20160201; A61B 2017/0725 20130101; A61B 2017/2943 20130101; A61B
17/072 20130101; A61B 90/30 20160201; A61B 2090/065 20160201; A61B
2017/07278 20130101; A61B 2090/0803 20160201; A61B 17/115 20130101;
A61B 34/76 20160201; A61B 34/30 20160201; A61B 2017/00371
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.
Description
REFERENCE TO RELATED APPLICATIONS
[0001] This application 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 6 Feb. 2009.
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), which discloses an
endocutter with distinct closing and firing actions. An example of
a motor driven surgical stapler is U.S. Publication No.
2007/0175958 (which is hereby incorporated herein by reference)
in-which excerpts are presented here to detail its base functions,
improvements, background, and components. At the end additional
improvements to the system are disclosed.
[0003] Quote from background and summary of invention from
US2007015958--"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 it 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 Ibs). 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.
SUMMARY
[0006] 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
severe the clamped tissue.
[0007] 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.
[0008] 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.
[0009] 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).
[0010] 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.
[0011] 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.
[0012] 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.
[0013] 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."
[0014] The disclosure herein shows how one could embody a battery
powered gear driven self-contained endoscopic stapling device.
DESCRIPTION OF THE DRAWINGS
[0015] FIG. 1 is a perspective view of a distal end of surgical
stapler in accordance with the present invention.
[0016] FIG. 2 is a perspective view of a distal end of surgical
stapler in accordance with the present invention with the cartridge
removed from the channel.
[0017] FIG. 3 is a view of a distal end of surgical stapler in
accordance with the present invention similar to FIG. 1 showing a
lockout indicator.
[0018] FIG. 4 is a perspective view of a proximal end of surgical
stapler in accordance with the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0019] End-effector illumination Methods/Surgical site illumination
with 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. Shown in FIG. 1, is a distal end
3 of a surgical stapler 1 in accordance with the present invention,
including anvil 11, cartridge body 7, and channel 13. As seen from
that figure, an additional light source 5 could be positioned on
the end of the cartridge body 7 to illuminate tissue 9. This light
source 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. This would allow the
surgeon to not only light up the treatment site directly, it could
allow for backlighting of structures to see the internal components
like vasculature or with a laser pointer allow the surgeon to point
out areas of interest to other via the traditional scope.
[0020] This would be very easy to do by allowing one or more
contacts 21 on the back of the cartridge 7 that would engage
contacts 23 within the channel. This would allow the surgeon to
energize the light as needed by energizing contact set via a switch
positioned on the handle 31. This switch could even have variable
intensity as the one described in could control the actuation speed
of the main, device.
[0021] As noted above, U.S. publication 2007/0175949 further
discloses in FIGS. 45-47 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 31. An
indicator 33 (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. Alternatively an indicator 35 could be located near the
distal end 3 which would provide immediate information to the
surgeon and loader if the cartridge is "good to go" or not. 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 the publication
20070175958) 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.
[0022] 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.
[0023] Automatic advancement and retraction of an electrical
endocutter: There are several steps within the function of a
stapler that must be accomplished in an established order. Once the
closure trigger is clamped actuation of the firing cycle is the
next necessary step. After for actuation 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 can begin to accomplish these steps
itself. Internal switches or circuits could be added to allow for
these steps to automatically be initiated. The next challenge is to
allow for the user to intuitively be able to delay, slow or stop
the automatic actuations. For instance, the same actuation button
that would allow for firing initiation in a tactile feedback device
like 11/344,035 could be used to slow or stop an automatic return
system by the user depressing the button during the retraction.
Once pressure was removed from the button the auto-return would
recommence. The same could be for auto-firing where if the system
did not require a button to, fire, but a control was provided that
moved with the knife motion that the user could depress that would
stop or slow its deployment but would be unnecessary if the system
was see to be running correctly.
[0024] 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. 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.
[0025] Use of a non-sterile battery within a sterilized device I
Packaging as a sterility barrier for battery pack reuse: 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.
[0026] 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. US publication 20070175958 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 rotatory 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.
[0027] 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
Endeffector 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.
[0028] 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.
[0029] 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.
[0030] 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.
[0031] 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.
[0032] 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.
[0033] 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 11/231,456 and
11/540,735 are around 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. 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.
* * * * *