Note: Descriptions are shown in the official language in which they were submitted.
CA 02608791 2013-06-05
SURGICAL STAPLER WITH TIMER AND FEEDBACK DISPLAY
BACKGROUND
1. Technical Field
The present disclosure relates to surgical instruments. More
particularly, the present disclosure relates to a surgical stapling device
that
has a feedback and a timer device. Even more particularly, the present
disclosure relates to a surgical stapling device that has a controller to
modulate one or more parameters of the surgical stapling device and to
provide for compression of tissue. Still even more particularly, the present
disclosure relates to a surgical stapling device that may also include a
sensory indicator (i.e., visual, audible, tactile) which determines position,
time,
or other valuable user feedback.
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2. Ba ground of the Related Art
Once under pressure from a jawed structure, such as a clamping
device, of a surgical stapler, the body tissue will slowly compress.
s Compression by a clamping device reduces the amount of blood and fluid to
the clamped tissue. Without such compression, an uncompressed body
tissue remains thicker whereas the compressed body tissue would be thinner,
and more compact. Compressing the tissue also causes blood and other fluid
to generally traverse from the high pressure or compressed area to another
low pressure or adjacent area.
Once released, the fluid due to the visco-elastic property of the tissue
will return from the adjacent area to the previously compressed tissue. Some
current surgical stapling devices initially compress tissue prior to the
is introduction of the staple into the body tissue. The amount of time
tissue is
compressed is currently left to the discretion of the surgeon. The surgeon
manually controls the amount of time that the tissue is compressed prior to
firing the staples into tissue. It would be therefore desirable to have a
surgical
stapling device that consistently fires staples after a predetermined amount
of
compression.
SUMMARY
According to a first embodiment of the present disclosure, there is
provided a surgical stapler that has a handle assembly including a stationary
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handle and a pivotable handle mounted for manipulation through an actuating
stroke. In another embodiment, the stapler may have a trigger that is
operable to manipulate a cam member through the actuating stroke. The
stapler also has an elongated body extending distally from the handle
assembly and defining a longitudinal axis and a staple cartridge supported
adjacent the distal end of the elongated body and containing a plurality of
staples.
The stapler further has an anvil pivotally mounted in relation to the
to cartridge adjacent the distal end of the elongated body with the anvil
having a
fastener forming surface thereon and being mounted for pivotal movement in
relation to the cartridge between an open position having a distal end spaced
from the staple cartridge and a closed position in close cooperative alignment
with the staple cartridge. The stapler also has an actuation sled supported
is within the cartridge. The actuation sled moves to urge the plurality of
staples
from the cartridge.
The stapler further has a drive assembly including a body having a
working end and a cam member supported on the working end. The cam
20 member is positioned to translate relative to the anvil to maintain the
anvil in
the closed position during firing of the stapler. The trigger or pivotable
handle
is operatively connected to the drive assembly such that manipulation of the
pivotable handle through its actuating stroke effects translation of the cam
member relative to the anvil. The stapler also has a channel for supporting
25 the staple cartridge and a controller configured to control the
actuation sled
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supported within the cartridge. The controller delays movement of the
actuation sled to urge the plurality of staples from the cartridge for a
predetermined time period when the anvil is in the closed position and in
cooperative alignment with the staple cartridge.
According to another aspect of the present disclosure, the surgical
stapler has a handle assembly including a stationary handle and a trigger
configured to manipulate a cam member through an actuating stroke. The
stapler also has an elongated body extending distally from the handle
to assembly and defining a longitudinal axis and a staple cartridge
supported
adjacent the distal end of the elongated body with staples. The stapler
further
has an anvil pivotally mounted in relation to the cartridge adjacent the
distal
end of the elongated body. The anvil has a fastener forming surface thereon
and is mounted for pivotal movement in relation to the cartridge between an
Is open position having a distal end spaced from the staple cartridge and a
closed position in close cooperative alignment with the staple cartridge.
The stapler also has an actuation sled supported within the cartridge.
The actuation sled moves to urge the staples from the cartridge. The drive
20 assembly includes a body having a working end and a cam member
supported on the working end. The cam member is positioned to translate
relative to the anvil to maintain the anvil in the closed position during
firing of
the stapler.
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The trigger is connected to the drive assembly such that manipulation
of the trigger through its actuating stroke effects translation of the cam
member relative to the anvil. The stapler also has a channel for supporting
the staple cartridge. The stapler also has a controller_ The controller is
configured to control the actuation sled supported within the cartridge_ The
controller delays the actuation sled's movement to urge the plurality of
staples
from the cartridge for a predetermined time period when the anvil is in the
closed position and in cooperative alignment with the staple cartridge_ The
surgical stapler also has an indicator connected to the controller. The
io controller controls the indicator to provide an indication when the
predetermined time period is reached.
According to another embodiment of the present disclosure, there is
provided a method for stapling tissue. The method includes the steps of
is locating tissue between a staple cartridge and an anvil and compressing
tissue between the staple cartridge and the anvil. The method also has the
step of manipulating an actuator to fire staples from the staples cartridge.
The
actuator is configured to automatically delay firing staples for a
predetermined
time period. The predetermined time period is suitable in length to allow
20 compression of the tissue for the predetermined time period and to allow
tissue to settle from a first initial state into a second compressed state.
The
method also has the steps of urging staples from the staple cartridge through
the tissue at the elapse of the predetermined time period when the tissue is
in
the second compressed state.
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According to another aspect of the present disclosure, the surgical
stapler has a controller to place a delay between actuation of the firing
mechanism component and actual firing of the staple.
According to another aspect of the present disclosure, the surgical
stapler has a control device that controls a stroke parameter, a distance
parameter and/or a time parameter of a firing mechanism component to
increase a tissue compression time of the clamp.
io According to still another aspect of the present disclosure, the
surgical
stapler has a motor and a first switch. The first switch is connected to a
motor
and delays the motor from actuating in order to achieve an amount of tissue
compression by a clamp. The surgical stapler may have a second switch.
The second switch senses another location of a drive screw and actuates a
15 reverse function of the motor to return the drive screw to an initial
position.
According to still yet another aspect of the present disclosure, the
surgical stapler has an indicator that measure a distance traveled of the
drive
screw or a tissue compression time of the clamp.
According to still another aspect of the present disclosure, the surgical
stapler has a visual indicator that indicates a position of the firing
mechanism
component or indicates a status condition of the surgical stapling.
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In another embodiment of the present disclosure, there is provided a
surgical stapler. The stapler has a handle assembly including a trigger and a
clamping device with a staple cartridge including a plurality of staples and
an
anvil having a fastener forming surface thereon. The stapler has a controller
s configured to determine an occurrence of clamping by the anvil and the
staple
cartridge. The controller controls a firing of the plurality of staples from
the
staple cartridge. When the trigger is actuated the controller delays firing of
the plurality of staples from the staple cartridge to provide for a
predetermined
=
time period of tissue compression of the tissue between the anvil and staple
cartridge. The controller outputs a control signal to allow firing once the
predetermined time period is reached.
DESCRIPTION OF THE DRAWINGS
Other and further objects, advantages and features of the present
disclosure will be understood by reference to the following specification in
conjunction with the accompanying drawings, in which like reference
characters denote like elements of structure and:
Fig. 1 is a perspective view of a first embodiment of a surgical stapler
of the present disclosure;
Fig. 2 is a block diagram of a number of components of the surgical
stapler of Fig. 1;
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Fig. 2A is an exploded view of a channel of the surgical stapler of Fig.
1;
Fig. 2B is an exploded view of the staple cartridge, anvil and the drive
sled of Fig. 1;
Fig. 3 is a perspective view of another embodiment of the surgical
stapler of the present disclosure having a plurality of lights;
io Fig. 4 is a perspective view of still another embodiment of the surgical
stapler with a linear indicator or display;
Fig. 5 is a perspective view of yet another embodiment of the surgical
stapler having a digital indicator or display;
Fig. 6 is a perspective view of still another embodiment of the surgical
stapler with an analog indicator or display;
Fig. 7 is a cross sectional view of the surgical stapler of Fig. 3 along
line 7-7;
Fig. 8 is another cross sectional view of still another embodiment of the
surgical stapler of the present disciosure along line 7-7 of Fig. 3 with the
stapler having a first switch and a second switch;
zs
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Fig. 8A is another cross sectional view of another embodiment of the
stapler of Fig. 8 having the first switch which engages a tab on the lever;
Fig. 8B is still another cross sectional view of yet another embodiment
s of the stapler of Fig. 8 having the first switch located distally on the
lever;
Fig. 9 is another perspective view of still another embodiment of the
surgical stapler with an audible alarm;
Fig. 10 is still another perspective view of another embodiment of the
surgical stapler having the display showing an image;
Fig. 11 is a schematic/cross sectional view of a travel path of a drive
member through an endoscopic portion of the surgical stapler with a resistor
strip; and
Fig. 12 is a schematic of another embodiment of the surgical stapler
having a non-contact sensor_
DETAILED DESCRIPTION
In the drawings and in the description which follows, the term
"proximar, as is traditional, will refer to the end of the apparatus which is
closest to the operator, while the term "distal" will refer to the end of the
apparatus which is furthest from the operator.
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The present disclosure can be used with any stapler device known in
the art and is intended to encompass the same, and is intended to be
discussed in terms of both conventional and endoscopic procedures and
apparatus. However, use herein of terms such as "endoscopic",
s "endoscopically", and "endoscopic portion", among others, should not be
construed to limit the present disclosure to an apparatus for use only in
conjunction with an endoscopic tube. The apparatus of present disclosure
may find use in procedures in these and other uses including but not limited
to
uses where access is limited to a small incision such as arthroscopic and/or
io laparoscopic procedures, or other conventional medical procedures. The
present mechanism may also be used with surgical stapling devices that have
independent or combined clamping and firing procedures. The present
disclosure may further be incorporated with surgical stapling devices that
have simultaneous or dependent clamping and firing mechanisms. The
s present disclosure is also intended to be used with such surgical
stapling
devices which have a discrete clamping gradient.
Referring now to the figures, wherein like reference numerals identify
similar structural elements of the subject disclosure, there is illustrated in
FIG.
20 1 a self-contained, powered surgical stapler constructed in accordance
with
an embodiment of the subject disclosure and designated generally by
reference numeral 10. The surgical stapler 10 is generally intended to be
disposable, however the disposable arrangement is non-limiting and other
non-disposable arrangements may be contemplated and are within the scope
25 of the present disclosure.
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The surgical stapler 10 of the present disclosure (shown in a
perspective view in Fig. 1 and described herein) includes a frame generally
represented by reference numeral 12 and handle generally represented by
reference numeral 14. The frame 12 defines a series of internal chambers or
spaces for supporting various inter-cooperating mechanical components of
the surgical stapler 10 as well as a number of staples therein for the
application to the body tissue.
The frame 12 supports a portion 16 or an extended tube-like portion.
The portion 16 is capable of being rotated and has a relatively narrow
diameter in a range of about 10 millimeters, and is for insertion into a small
opening or tube inserted into the body, such as in the abdominal cavity, or
other similar body cavities. The portion 16 has a longitudinal axis and has a
length appropriate for reaching the operation site in the interior of the
body.
The surgical stapler 10 may be used in conjunction with other instruments
such as endoscopes or other such optical devices for visually examining the
interior of the body, for example, cameras by means of CCD devices, fiber
optics or other optical or recording devices.
Generally, portion 16 of the surgical stapler 10 is inserted through the
small opening or wound, and is manipulated to the operation site. The
present disclosure is intended to be used with any surgical stapler including
but not limited to surgical staplers having simultaneous clamping and
2$ independent clamping.
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Portion 16 has a fastening assembly generally represented by
reference number 18 and cutting assembly (not shown) that is known in the
art. The fastening assembly 18 and the cuffing assembly (not shown) are
$ located in a housing 20 which carries a fastener and an optional cutter
to the
operation site. The fastening assembly 18 in this particular embodiment has a
jaw or a staple cartridge 21 and a second jaw or anvil 22. The staple
cartridge 21 and the anvil 22 may be brought into close cooperative alignment
with one another so the jaws 21, 22 form a clamp therebetween. The jaws
io 21, 22 may be a first and second jaw that open and close or may be
another
different clamping type structure as is known in the art. The staple cartridge
21 may be located at the distal end of the housing 20, in the jaws 21, 22
themselves or may be located in other locations as described in United States
Patent No. 7,044,353 to Mastri, et al. which is herein incorporated by
15 reference in its entirety. The staple cartridge 21 has one or a number
of rows
of staples. The surgical stapler 10 also has an anvil (not shown) and further
may include an optional knife (not shown) as is well known in the art for
accomplishing the stapling. It is appreciated that the closing of the jaws 21,
22 with the staple cartridge 21 and the anvil 22 may be accomplished by
20 pivoting the anvil 22 relative to the staple cartridge 21, or by
pivoting the
staple cartridge 21 relative to the anvil 22, or by pivoting both the staple
cartridge 21 and the anvil 22 relative to one another.
Generally, actuating the operating portion of the fastening assembly 18
25 is accomplished via intermediate components disposed on or within the
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narrow longitudinally extending tubular portion 16. In one non-limiting
embodiment, a cylindrical tubular sleeve member surrounds the portion 16.
The sleeve may be manipulated in a direction with the longitudinal axis of the
surgical stapling device. The sleeve slides onto the anvil 22 for closing the
jaws 21, 22 that are biased open by a biasing device (not shown) to
accomplish the clamping. The surgical stapler 10 of the present disclosure
has three basic actions or functions, however, the present disclosure is
intended to be used with any surgical stapler including but not limited to
surgical staplers having simultaneous clamping (Le., clamping and firing the
stapler at the same time) and independent clamping (Le., clamping prior to the
staple firing).
First, portion 16 is introduced into the human or animal body and is
positioned with the jaws 21, 22 aligned at the desired stapling site to
receive
is the target tissue. This may involve rotation of the portion 16 relative
to the
body, either by rotating the surgical stapler 10 as a whole, by rotating
simply
the portion 16 relative to the frame 12 as permitted, or a combination of both
actions. Thereafter (Le., secondly), the surgical stapler 10 secures the
target
body tissue between the staple cartridge or jaw 21 in the distal portion of
the
2o housing 20 and the anvil 22. This is accomplished by a clamping action
of the
jaws 21, 22 or alternatively by another similar or different clamping member.
The jaws 21, 22 are allowed to remain in the closed position for a
desired period of time depending on the particular tissue. By configuring the
25 jaws 21, 22 to remain closed for a predetermined period of time allows
any
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excess liquid or fluid in the tissues to drain out of the body tissues prior
to
actuation of the stapling cartridge 21. This ensures that the liquid does not
traverse out of the tissues after firing to form non-uniform staples and
instead
ensures a proper and uniform staple formation.
With the target tissue clamped between the anvil 22 and the staple
cartridge 21, a Gemming surface which surrounds the housing 20 and anvil 22
is employed to close the jaws 21, 22 of the surgical stapler 10 and clamp the
tissue between the anvil 22 and the tissue contacting surface of the staple
io cartridge 21. The jaws 21, 22 are clamped by actuation of a lever 24
opposite
= the jaws 21, 22 as is known in the art. Thereafter, the surgeon applies
the
staples to the body tissue. A longitudinally extending channel is employed to
deliver longitudinal motion to an axial drive member and a tissue cutting
knife
as is known in the art.
The axial drive member or an axial drive screw contacts pusher
elements. The pusher elements drive the staples through the body tissue
against the fastener or forming surface of the anvil as discussed herein.
Typically, in the art the surgical stapler 10 fires usually by an actuation of
a
first trigger handle or alternatively using a trigger switch 26. Thereafter,
the
clamping action of the jaws 21, 22 is released and the surgical stapler 10 or
a
portion thereof may be withdrawn from the body.
Referring now to Fig. 2, there is shown a block diagram of the surgical
stapler 10 of the present disclosure. According to a first aspect of the
present
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disclosure, the surgical stapler 10 may have an optional controller 28. The
controller 28 is any electronic device being coupled to a memory for executing
one or more readable program instructions or alternatively may be a suitable
analog circuit. Still further, the controller 28 may be a suitable mechanical
member or linkage for controlling one or more functions of the surgical
stapler
la
The controller 28 is connected to an internal or external power supply
and a motor and is connected between the anvil 22 and the stapling cartridge
ro 21. In an alternative embodiment a trigger handle or another actuating
switch
or component 26 is mechanically or electronically linked or otherwise
connected to the stapling cartridge 21 as is known in the art as indicated by
a
dotted line, and the present disclosure is not intended to be limited to any
configuration. Once the stapling cartridge 21 is fired using the trigger
switch
is 26, the jaws 21, 22 are opened and the firing mechanism is retracted.
The
surgical stapler 10 as a whole may be withdrawn from the body tissue or may
be manipulated for a next or second stapling operation as shown.
The present surgical stapler 10 has the controller 28 which is
20 connected to one of the jaw or anvil 21 or jaw or staple cartridge 21
and the
trigger switch 26 or is connected to both jaws 21, 22 and the trigger switch
26.
In one embodiment, once the desired site is reached, the surgeon uses the
jaws 21, 22 to compress the selected body tissue. Alternatively, the surgical
stapler 10 may have a single drive component that can actuate both the anvil
25 22 and stapling cartridge 21.
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Thereafter, the controller 28 may provide for a requisite amount of
delay between clamping and firing (or after clamping and before firing) to
ensure tissue compression and expulsion of fluid. After the desired
compression is reached, the stapling cartridge 21 may be automatically
engaged by the controller 28 to fire the staples from the stapling cartridge
21
into the body tissue or alternatively the controller 28 may send a signal to
the
surgeon thereby informing the surgeon a suggestion that the surgeon is to fire
the staples. It is envisioned that the firing may be automatic or manual.
Furthermore, the controller 28 may control the speed with which the
staples are fired from the staple cartridge 21. Still further, the controller
28
may control an amount of delay before firing. The controller 28 in one
embodiment may provide for a predetermined amount of time to elapse prior
is to outputting a signal to the stapling cartridge 21. In another powered
stapler
embodiment, the controller 28 may slow a motor speed to increase the body
tissue compression time,
in still another embodiment, the controller 28 may engage a dampening
device 30. The dampening device 30 is configured to slow the actuating of
the staple cartridge 21 in order to increase the overall compression time of
the
body tissue. Such a dampening device 30 may be a hydraulic or a pneumatic
type damper or any other device that may dampen or modulate the operation
of one or more components of the surgical stapler 10. In another
embodiment, the trigger 26 may simply hold the fire signal for a
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predetermined time period in associated control circuitry and upon the
expiration of the predetermined time period may communicate the signal to
the stapling cartridge 21.
The controller 28 may be configured to slow a motor speed, modulate a
gear or, still further, engage a circuitry of the motor to slow an operation
thereof to otherwise reduce actuation, le, a rotation rate of the axial drive
screw. Still further, the surgical stapler 10 may also include an override
switch 32. The override switch 32 is an automatic or manual device (or other
io switch) that selectively disengages the controller 28 to permit direct
actuation
of the stapling cartridge 21 by the trigger switch 26 without any delay at the
surgeon's discretion.
In one aspect of the present disclosure, the present surgical stapler 10
includes jaws 21,22 which compresses tissue between the anvil 130 and the
stapler cartridge 132 of the stapling cartridge 21 (Fig. 28). The jaws 21,22
are understood in the art as a device that allows the surgeon to manipulate
and compress tissue between the anvil 130 and the staple cartridge 132 prior
to urging of the staples 158 from the staple cartridge 132 as shown in Fig.
2B.
The jaws 21, 22 may be independently powered by a power source such as a
motor or pneumatic device, or may be powered by the same power source as
the staple cartridge 21. The surgical stapler 10 uses the jaws 21, 22 to clamp
tissue between the stapler cartridge 132 and the anvil 130 (Fig. 2b), then
when the stapler 10 is fired the jaws 21, 22 may be further tightened and then
the staples 158 urged from the stapling cartridge 21.
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In one aspect, the surgical stapler 10 may pre-clamp or compress
tissue using the jaws 21, 22 for a first interval. The first time interval may
be
preset and fixed, or variable depending on the tissue type. The first time
s interval may be for minutes, seconds or any other variable or fixed
predetermined period of time. Then prior to stapling, the jaws 21, 22 may
further tighten to further compress the tissue for another second compression
lime interval and then fire. The second time interval may be different from
the
first time interval and can be shorter or longer than the first. In another
to aspect, the instrument may pre-clamp or compress tissue using the jaws
21,
22 and then simply automatically fire the device to urge the staples 158 from
the staple cartridge 132 at the conclusion of the first interval. Various
configurations are possible, and the present surgical stapler 10 may have
program instructions for any number of compression intervals desired by the
is surgeon and/or designer. The surgical stapler 10 may alternatively
further
use a second separate clamping device in association with the stapler 10. It
is understood that the present disclosure may be incorporated into an
instrument that approximates the tissue before firing such as with a TA
surgical stapler such as United States Patent No. 6,817,508 to Racenet, etal.
20 which is herein incorporated by reference in its entirety, or can be
used with
an instrument that requires no such approximation before firing.
In another embodiment of the present disclosure, the surgical stapling
device 10 may provide the surgeon with feedback by virtue of an indicator 36.
25 The indicator 36 may display an amount of compression time and/or
provide
=
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feedback of the status of the stapling, or display information relating to the
location of the drive screw, or drive member. In another embodiment of the
present disclosure, the surgical stapler 10 may not have separate clamping
and firing actuators and include a clamping gradient indicator 36 or
simultaneous clamping and firing indication mechanism. For example, the
surgical stapler 10 may be configured to allow control of the firing speed
which, in turn, controls the clamping speed and timing and then provide
optimal compression for squeezing the tissue and pushing the blood and fluid
out of the tissue at the desired site.
Fig. 2A shows an exploded view of a number of components of the
surgical stapler 10 of Fig. 1. The stapler 10 has a rack 100 that is slidable
in
the handle portion 14. The rack 100 interfaces with a clamp tube 102. On a
distal side of the clamp tube 102 is a channel 104. The channel 104 engages
with the clamp tube 102 and a pair of forks 106, 108 on a distal side thereof.
The stapler 10 also has an upper cover 110 and a lower cover 112, and an
extension tube 114. The extension tube 114 engages with a collar tube 116.
The stapler 10 also has a rotation knob 118 with a channel portion 120. The
channel portion 120 has a pair of camming surfaces 122 on a distal end. The
distal end also has a crimp 124 in a distal side to receive the anvil 22.
=
in operation, the rack 100 slides and moves the clamp tube 102
distally. The clamp tube 102 is provided to interconnect the handle portion 14
and the extension tube 114. The channel 104 is slidably mounted for
reciprocal longitudinal motion. The extension tube 114 provides support for
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the surgical stapler 10 and has slots that interface with the collar tube 116.
The surgical stapler 10 also has a support 120 for longitudinal motion and to
operate the stapling mechanism as described in Fig. 2b. The operation of
these components is well known and is disclosed in United States Patent No,
5,318,221 to Green, etal., which is herein incorporated by reference in its
entirety.
Advantageously, the rack 100 moves distally to advance the channel
104 in a distal manner. The channel 104 delivers longitudinal motion to a
lo pusher cam bar as is known in the art for operation of the stapler
cartridge 21
shown in Fig. 2b. It should be appreciated that the components shown in Fig.
2a only illustrate one embodiment of the present surgical stapler 10, and
instead of the rack 100, the surgical stapler 10 may have a drive screw (not
shown) for longitudinal motion and in order to actuate the stapler cartridge
21.
Referring now to Fig. 2b, there is shown an exploded view of the anvil 22 and
the stapler cartridge 132 having an actuation sled 169.
Referring to FIG. 2b, the stapler cartridge 21 includes an anvil
assembly 130 and a cartridge assembly 132 shown in an exploded view for
illustration purposes. The anvil assembly 130 includes anvil portion 22
having a plurality of staple deforming concavities (not shown) and a cover
plate 136 secured to a top surface of anvil portion 134 to define a cavity
(not
shown). The cover plate 136 prevents pinching of tissue during clamping and
firing of the surgical stapler 10. The cavity is dimensioned to receive a
distal
end of an axial drive assembly 138.
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The anvil 130 has a longitudinal slot 140 that extends through anvil
portion 130 to facilitate passage of retention flange 142 of the axial drive
assembly 138 into the anvil slot 140. A camming surface 144 formed on anvil
22 is positioned to engage axial drive assembly 138 to facilitate clamping of
tissue. A pair of pivot members 146 formed on anvil portion 130 is positioned
within slots 146' formed in carrier 148 to guide the anvil portion 130 between
the open and clamped positions.
The stapler 10 has a pair of stabilizing members 152 engage a
respective shoulder formed on carrier 148 to prevent anvil portion 30 from
sliding axially relative to staple cartridge 132 as camming surface of the
anvil
130 is deformed. Cartridge assembly 132 includes the carrier 148 which
defines an elongated support channel 154. Elongated support channel 154 is
dimensioned and configured to receive the staple cartridge 132 which is
shown above the carrier 148 in the exploded view of Fig. 2b. Corresponding
tabs and slots formed along staple cartridge 132 and elongated support
channel 148' function to retain staple cartridge 132 within support channel
154
of carrier 148. A pair of support struts formed on the staple cartridge 132
are
positioned to rest on side walls of carrier 148 to further stabilize staple
cartridge 132 within support channel 154, however other arrangements to
support the cartridge 132 on the channel 154 can be used and this
arrangement is not limiting.
Staple cartridge 132 includes retention slots 156 for receiving a
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plurality of fasteners 158 and pushers 160. Longitudinal slots 156 extend
through staple cartridge 132 to accommodate upstanding cam wedges 162 of
the actuation sled 164. A central longitudinal slot 166 extends along the
length of staple cartridge 132 to facilitate passage of a knife blade (not
Referring to Fig. 3, the surgical stapler 10 may include indicator 36
which may be any device known in the art to provide sensory feedback to the
surgeon. The indicator 36 may be any device that permits a visual, tactile or
14. Alternatively, the indicator 36 may be disposed on portion 16, on the
trigger switch 26, on the lever 24 or in any other suitable location where the
indicator 36 may be easily viewed by the surgeon without a change in position
20 of change in footing by the surgeon.
In one embodiment, as shown the indicator 36 includes a number of
light bulbs 38. The lights 38 may be one light or a series of many lights
bulbs
or LEDs with one color or an assortment of two or more colors. Each of the
25 lights 38 may have a color representing one or more conditions of the
surgical
22
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stapler 10. Alternatively, one or all of the lights 36 may flash to indicate a
condition of the surgical stapler 10.
Upon being actuated by the trigger switch 26, the surgical stapler 10
may impart a delay before firing of the staples. However, in order to provide
the proper feedback to the surgeon, the lights 38 provide, for example, a
visual indication of the progress of the firing of the stapling cartridge 21.
For
example, still referring to Fig. 3, there is shown a first light 40, a second
light
42, a third light 44, a fourth light 46, and a fifth light 48. As the axial
drive
io screw (not
shown and in the handle) travels the predetermined drive path the
lights 40, 42, 44, 46, and 48 illuminate in series to portray the relative
distance
of the drive screw on the exterior of the handle. When the lights 40, 42, 44,
46, and 48 are illuminated, the stapling cartridge 21 fires which ensures that
proper tissue compression occurs prior to deployment of the staples.
Referring now to Fig. 4, in another exemplary embodiment of the
present disclosure, the surgical stapler 10 includes a linear indicator 50
having a plurality of discrete segments, first segment 52, second segment 54,
third segment 56, fourth segment 58, and fifth segment 60. Again, once the
trigger switch 26 is actuated to fire the stapling cartridge 21, the segments
52,
54, 56, 58, and 60 each illuminate in a predetermined pattern to indicate to
the surgeon the status of the progression of the drive screw in the handle 14.
Upon all of the segments 52, 54, 56, 58, and 60 being illuminated, the
stapling cartridge 21 fires the staple into the body tissue with assurance
that
23
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an amount of compression time of the body tissue has lapsed. Linear display
50 may have one or more different colors or combinations of colors to indicate
a position of the drive screw such as "red" to indicate firing and "green" to
indicate that the firing is complete or vice versa. Still further the linear
display
For example, the linear display 50 may indicate "FIRE" or
15 In still another exemplary embodiment of the present disclosure shown
in Fig. 5, the surgical stapler 10 may include a digital display 62. The
digital
display 62 may indicate a count down or count up (or other time interval)
after
actuation of the trigger switch 26. For example, the digital display 62 may
count down to the desired stapling time after compression to ensure a
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Alternatively, the digital display 62 may be selectively preset and input
by the surgeon using an input device (not shown) or button. The surgeon
may input a time period of clamping into the display 62. Thereafter, the
display 62 will suggest firing at the elapse of the clamping time period, or
may
automatically fire after a predetermined clamping time elapses (e.g., such as
from about ten seconds to forty five seconds) to ensure proper tissue
compression. The digital display 62 may be configured to count down from
the predetermined set interval of clamping and visually communicate a signal
to the controller 28. The controller 28 after receiving the signal allows the
io desired time period of clamping to elapse. After the set time period
expires,
the controller 28 may communicate a second signal to actuate the stapling
cartridge 21. Alternatively, the controller 28 may simply modulate the speed
of the motor to commence operation at a speed suitable to actuate the
stapling cartridge 21 at the end of the desired time period. In still yet
another
is embodiment, the digital display 62 may be configured to initiate
counting after
commencement of the clamping of tissue and then simply display the time
from that point onwards to allow the surgeon to monitor and manually actuate
the trigger switch 26 at the expiration of the desired time period.
Thereafter,
the digital display 62 may simply display or flash the compression time to the
20 surgeon and the exact amount of elapsed time. It is appreciated that the
instrument may provide a predetermined delay and then indicate that the
instrument is ready to be manually fired, or alternatively the instrument may
delay then indicate and then automatically fire.
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Referring now to Fig. 6, the surgical stapler 10 may alternatively have
an analog display 64 disposed on the outer surface of the handle 14 which
functions similar to the digital display 62. Analog display 64 may have an
audible alarm or alternatively have a flashing light to indicate that the
appropriate tissue compression time has been reached or exceeded.
Referring now to Fig. 7, there is shown a cross sectional view of the
handle 12 of the surgical stapler along line 7-7 of Fig. 3. In this
embodiment,
the surgical stapler 10 is a powered device and has a motor 66 with a driving
io mechanism. The driving mechanism is a drive output shaft 68. Shaft 68
connects to a first gear 70. The first gear 70 is connected to a second gear
72 which, in turn, engages an axial drive screw 74_ The motor 66 may be a
device that drives one or more components of the surgical stapler 10.
The drive screw 74 is a threaded rod having a number of helical
grooves that are intended to rotate and contact another member to actuate
the stapling cartridge 21 in the distal location of the surgical stapler 10
once
compression is made by the surgeon using the clamp or jaws 21, 22. The
axial drive screw 74 is disposed in toothed engagement through a central
bore 76 of the second gear 72. The axial drive screw may also be disposed
offset from the second gear 72 or in any other desired geared arrangement.
Upon actuation of the motor 66, the axial drive screw 74 rotates and traverses
distally through the portion 16 of the surgical stapler 10 to engage the
stapler
cartridge 21 as is well known in the art. Alternatively, the surgical stapler
10
may have a drive piston or plunger instead of the axial drive screw 74 or a
26
CA 02608791 2013-06-05
single drive mechanism to control both the anvil 22 and the stapling cartridge
21. Such mechanisms are well known in the art and may be found in United
States Patent Nos. 6,330,965 B1 to Milliman, et al., 6,250,532 B1 to Green,
et al., 6,241,139 B1 to Milliman, et al., 6,109,500 to Alii et al., 6,202,914
B1 to
Geiste, et al., 6,032,849 to Mastri, et al. and 5,954,259 to Viola, et al.
The surgical stapler 10 may include a first switch 80. Switch 80 is
located in a fixed position of the handle as shown. The stapler 10 also has a
second switch 82 disposed distally relative to the first switch 80 that is
distal
or near the path of the drive screw 74 in the first initial position 78.
Likewise,
the second switch 82 in a second firing position 84 which is disposed distally
from the first initial position and proximal or near the path of the drive
screw
74. Each of the first and second switches 80, 82 is a limit switch, but
alternatively may be any switch known in the art to change or toggle from a
first position to a second position by a simple motion of the axial drive
screw
74 traversing past or adjacent to the respective limit switch.
Once the axial drive screw 74 or a portion thereof traverses past the
first switch 80, the first switch communicates a signal to the controller 28
by
lead 86. The controller 28 thus illuminates the indicator 36 or a portion
thereof by lead 88 to indicate to the surgeon a first location of the axial
drive
screw 74.
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Thereafter, the drive screw 74 or a portion thereof traverses or contacts
the second switch 82 at the second firing position 84. The second switch 82
is also a limit switch and communicates a second signal to the controller 28
by
lead 90 of the location or firing of the stapler cartridge 21. The controller
28
s then illuminates indicator 36 (or another portion thereof) by lead 88 to
indicate
to the surgeon that the stapling has been completed. At the conclusion of the
stapling, the surgeon/operator will initiate retraction and then will reverse
a
direction of the motor 66 by lead 92. The motor 66 then reverses operation
and returns the axial drive screw 74 to the initial position 78 for the next
io stapling operation.
Alternatively, controller 28 upon receiving the first signal from the first
switch 80 by lead 86 modulates one or more operations of the surgical stapler
10. For example, in response to receiving of the first signal, the controller
28
15 can control one or more parameters of the surgical stapler 10 including
tissue
gap, speed of the motor 66, control stroke of the axial drive screw 74, axial
drive screw travel distance, rotational rate of the axial drive screw and any
combinations thereof.
20 Referring now to Fig. 8, the surgeon may operate/ engage the firing
mechanism in order to actuate the stapling cartridge 21. The firing
mechanism actuates the motor 66 shown in Fig. 8. The axial drive screw 74
commences rotation and by traversing past switch 80 the drive screw 74
actuates the first switch 80. The first switch 80 outputs the signal to the
25 controller 28 by lead 86. The controller 28 in response to the signal
from the
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first switch 80 then actuates the first light 40 by lead 92. The surgical
stapler
may further have a suitable structure in order to engage a stop feature.
The stop feature prohibits overdrive of the drive screw 74.
5 Thereafter,
after the axial drive screw 74 traverses a predetermined
distance to ensure tissue compression by the clamp or jaws 21, 22. The
second switch 82 is actuated and outputs a second signal to the controller 28
by lead 90. The controller 28 in response to the second signal illuminates the
second light 42 by lead 94. The second light 42 indicates that the stapling
10 cartridge 21 has fired. The second switch 82 may further emit a signal
to the
controller 28 to reverse or cease motion in that direction of the motor 66 or
to
return the axial drive screw 74 to the initial position. The
physician/operator
may also manually reverse the direction of the motor 66. A third light 44 may
illuminate to indicate to the surgeon that the axial drive screw 74 is
returning
is to the initial position 78.
Fig_ 8A illustrates another embodiment of the present stapler. In the
embodiment shown, the surgeon may operate/engage the firing mechanism in
order to actuate the stapling cartridge 21. However, the first switch 80' is
in a
different location than the embodiment shown in Fig. 8. In this embodiment,
the first switch 80' is located immediately under the lever 24 proximal to
handle 14. The switch 80' in the embodiment of Fig. 8A engages a tab 24'
disposed on the lever 24. When the lever 24 is actuated and driven toward
the handle 14, the tab 24' contacts switch 80', and the switch 80' outputs the
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signal to the controller 28 by lead 86. The controller 28 in response to the
signal from the first switch 80 then actuates the first light 40 by lead 92.
Thereafter, after the axial drive screw 74 traverses a predetermined
s distance to ensure tissue compression by the clamp or jaws 21, 22, the
second switch 82 is actuated and outputs a second signal to the controller 28
by lead 90. Again, the controller 28 in response to the second signal
illuminates the second light 42 by lead 94. The second light 42 indicates that
the stapling cartridge 21 has fired. The second switch 82 that is actuated by
to switch 80' may further emit a signal to the controller 28 to reverse or
cease
motion in that direction of the motor 66 or to return the axial drive screw 74
to
the initial position. A third indicator 44 may be included to indicate to the
surgeon that the axial drive screw 74 is returning to the initial position 78.
15 Figure 8B shows still another embodiment wherein the first switch 80"
is located at still another location of the handle 14, and on an opposite
distal
side of the lever 24 in proximity to pivot Various configurations are possible
and within the scope of the present disclosure, and switch 80" may be placed
in various configurations relative to the lever 24.
Fig. 9 shows the surgical stapler 10 with a lever 24. The lever 24,
shown in the elevated position, controls the clamp or jaws 21, 22, however
this arrangement is not limiting and another driving member may control the
clamp or jaws 21, 22 such as the motor 66 (Fig. 7). The lever 24 opens and
closes the jaws 21, 22 of the clamp to compress the body tissue prior to
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surgical stapling. The surgical stapler 10 further includes an electrical
contact
96 with an electrically conductive member to complete a suitable analog or
digital circuit. The electrical contact 96 is in a complementary nesting
location
of the lever 24 when the lever is in a lowered position or mating with the
s handle 14. When the lever 24 is lowered from an elevated or raised
position
to the lowered position or contacting the handle 14, the lever 24 engages the
electrical contact 96. The electrical contact may complete a suitable timer
circuit of the display 62 when in the lowered position. In this embodiment,
the
electrical contact 96 commences the display 62. The display 62 may count
to upwards from zero to a predetermined time limit, or may count down from
an
ideal predetermined tissue compression time interval. Once the displayed
time reaches the predetermined time interval, an audible alarm 98 may sound.
The audible alarm 98 provides the surgeon with a cue that the optimal tissue
compression time has been reached, and that the firing mechanism should be
is actuated in order to fire the staple from the staple cartridge 21 to
ensure a
uniform staple formation.
Fig. 10 illustrates in still another embodiment where the clamp formed
by jaws 21, 22 is actuated by lowering the lever 24. Contemporaneously, the
20 timer circuit of the display 62 is activated by the electrical contact
96 on the
lever 24. The indicator 36 may be the linear display 50 which indicates a
first
color to prompt for the actuation of the stapling mechanism 21 by the trigger
switch or button 26. The display 50 may then display a second image or
illuminate the number of segments corresponding to a travel path of the axial
25 drive screw 74 as shown in Fig. 7_ Upon actuation, the second switch 82
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outputs a signal to the controller 28. The controller 28 then stops the motor
66, and the controller outputs a control signal to the display 50 to modulate
the display from the first color to another second color or from a first image
to
a second image to indicate that the stapling cartridge 21 has fired.
Optionally,
s the controller
28 may further sound the audible alarm 98 indicating that the
stapling cartridge 21 has fired. The alarm may be any sound or audible
pattern, including a buzzer, a song, a chirp, a chime or any combinations
thereof. Various indicator configurations are possible and within the scope of
the present disclosure.
In still another embodiment, the jaws 21, 22 may be actuated by
lowering the lever 24. Contemporaneously, the timer circuit of the display 62
is activated by the lever 24. Thereafter, the indicator 36 indicates a first
indication to prompt for an actuation of the stapling cartridge 21 by
actuating
is switch 26 after
a desired time period elapses. Once the trigger switch 26 is
actuated, the controller 28 activates the motor 30. The motor 30 then moves
the drive screw 74 as shown in Fig. 7.
As the axial drive screw 74 moves in an axial manner, the drive screw
(or another plunger 100 connected thereto as shown in Fig. 11) contacts a
second member 102. Second member 102 may be any member that
modulates based on the motion of the plunger 100 and that can be detected
or sensed by another device to provide an indication to the surgeon. The
second member 102 may be a resistor strip which changes a resistance along
a travel surface 104 of the plunger 100 as the plunger 100 or the axial drive
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screw 74 traverses along the portion 16 of the surgical stapler 10 (or other
suitable travel surface location). The resistor strip 102 is coupled to
indicator
36 such that the change in resistance of the resistor strip 102 selectively
illuminates each of the fights 40 through 48 to signal an amount of travel by
the axial drive screw 74 or the plunger 100 or other suitable drive member.
Alternatively, the resistor strip 102 may be coupled to another indicator
36 such as a linear display 50. The display 50 may illuminate the number of
segments 52, 54, 56, 58, and 60 corresponding to a travel of the axial drive
io screw 74 or the plunger 100 until the axial drive screw actuates the
stapler
cartridge 21. Upon actuated, the resistor strip 102 outputs a signal to the
controller 28 which modulates the operation of the motor 66, and sends
another second signal to the display 50 to indicate that the stapling
cartridge
21 has fired. The display 50 in response thereto may then display a suitable
is graphical image, another color, a textual message, or any other
indication to
indicate to the surgeon that the firing of the stapling cartridge 21 has
concluded. Various indicator configurations are possible and within the
scope of the present disclosure.
20 Referring now to Fig. 12, in yet another embodiment of the present
disclosure, the surgical stapler 10 may further include a non-contact sensor
106. The non-contact sensor 106 may optionally be a so-called 'Hall effect
non-contact sensor" (or alternatively any other non-contact sensor) that is
based in part on the physical principle of the Hall effect named after its
25 discoverer E. H. Hall.
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For example, end 108 of the axial screw 74 is directly connected,
geared to, or offset from the motor 74, and a cap like free end 110 of axial
screw 74 contacts the stapler cartridge 21 to actuate the stapler cartridge
and
to fire the staple as discussed previously. The free end 110 of the drive
screw
74 has a magnetic member 112 which connects thereto and which will not
become dislodged by a rotation of the drive screw 74. Alternatively, the
magnetic member 112 may be disc shaped and simply connect to the free
end 110. In one initial orientation, free end 110 and the magnetic member
to 112 are disposed closely adjacent, or near to the non-contact sensor
106. At
this initial orientation, the magnetic member 112 is separated by a first
distance "d" from the non-contact sensor 106.
Once the trigger switch or button 26 is actuated, the motor 66 is
Is actuated, and rotates, the drive axial screw 74 to traverse distally to
actuate
the stapler cartridge 21 as described above. In the second orientation after
the motor 66 has been actuated, the magnetic member 112 moves and is a
second distance "d" away from the non-contact sensor 106. The second
distance is any distance greater than the first distance "d". As the magnetic
20 member 112 moves away from the non-contact sensor 106, the non-contact
sensor now located the second distance away from the magnetic field of the
magnetic member 112 modulates an operation of the motor 66.
The term "modulation" is defined as modulating amount of voltage
2$ received by the motor 66 in a dynamic manner, turning the motor dofr at
a
34
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desired stroke, changing the motor speed, drive gear reduction of the motor,
reduction of the axial drive screw pitch, or a change in the voltage or the
current input of the motor, or changing another firing component, a change of
the motor components and any combinations thereof. This may thereby slow
the operation of the motor 66 to increase an amount of compression time of
the body tissues between jaws 21, 22. In another alternative embodiment, the
magnetic member 112 may be disposed on a suitable drive piston instead of
the drive screw 66. As the drive piston travels away from the non-contact
sensor 106, a reduced or modulated amount of voltage may be provided to
io the motor 66. Still further in another alternative embodiment, the non-
contact
sensor 106 may be placed at the free end 110 of the drive screw 74 and the
magnetic member 112 fixed.
In another embodiment of the present disclosure, the surgical stapler
Is may have a combined drive mechanism. The combined drive mechanism
may control both a firing component of the stapling mechanism and a
clamping mechanism. The surgical stapler 10 may, upon being actuated, has
the drive mechanism advance to commence the clamping using the clamping
mechanism and then hold and wait thus providing a predetermined delay.
20 The surgical stapler 10 would then provide an indication to the
surgeon/operator once a desired amount of compression is reached.
Thereafter, the surgeon/ operator would then actuate the drive mechanism
after the time delay. The drive mechanism would then fire the staples from
the stapling cartridge 21 into the compressed tissues and thus ensure a
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uniform staple formation. The surgical stapler 10 thus provides a time delay
prior to stapling to ensure tissue compression.
Although being shown as an endoscopic surgical stapler, the present
drive system may be used with any surgical stapling device known in the art,
such as endoscopic surgical stapling devices, a pulmonary stapling device, a
GIA surgical stapling devices, an endo-GIA stapling device, a TA surgical
stapling device and any other stapler device for surgery know in the art. The
present disclosure may also be used with a single drive surgical stapler that
io drives both the clamp and the stapling device. The present disclosure
may be
incorporated into a device that approximates and then fires such as with a TA
surgical stapling device or with a surgical stapler without any such
approximation of tissue.
It should be understood that the foregoing description is only illustrative
of the present disclosure. Various alternatives and modifications can be
devised by those skilled in the art without departing from the disclosure.
Accordingly, the present disclosure is intended to embrace all such
alternatives, modifications and variances. The embodiments described with
reference to the attached drawing figures are presented only to demonstrate
certain examples of the disclosure. Other elements, steps, methods and
techniques that are insubstantially different from those described above
and/or in the appended claims are also intended to be within the scope of the
disclosure.
36
