U.S. patent application number 14/157243 was filed with the patent office on 2014-05-15 for staple trap for surgical stapler.
This patent application is currently assigned to Cardica, Inc.. The applicant listed for this patent is Cardica, Inc.. Invention is credited to Philipe R. Manoux, Benjamin J. Matthias, Jinhoon Park.
Application Number | 20140135832 14/157243 |
Document ID | / |
Family ID | 49919184 |
Filed Date | 2014-05-15 |
United States Patent
Application |
20140135832 |
Kind Code |
A1 |
Park; Jinhoon ; et
al. |
May 15, 2014 |
STAPLE TRAP FOR SURGICAL STAPLER
Abstract
An exemplary staple holder of a surgical stapler may include a
cavity defined therein, staples held within that cavity; an upper
surface; apertures defined through the upper surface through which
staples are deployable, at least one wedge movable within the
cavity, and at least one staple trap including a strip and arms
extending from and bent relative to the strip, where at least one
arm resides in a neutral position directly underneath a
corresponding aperture.
Inventors: |
Park; Jinhoon; (Mountain
View, CA) ; Manoux; Philipe R.; (Oakland, CA)
; Matthias; Benjamin J.; (Emerald Hills, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Cardica, Inc. |
Redwood City |
CA |
US |
|
|
Assignee: |
Cardica, Inc.
Redwood City
CA
|
Family ID: |
49919184 |
Appl. No.: |
14/157243 |
Filed: |
January 16, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13093815 |
Apr 25, 2011 |
8631990 |
|
|
14157243 |
|
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Current U.S.
Class: |
606/219 |
Current CPC
Class: |
A61B 2017/07228
20130101; A61B 17/068 20130101; A61B 2017/07278 20130101; A61B
2017/07271 20130101; A61B 17/07207 20130101; A61B 17/0644
20130101 |
Class at
Publication: |
606/219 |
International
Class: |
A61B 17/068 20060101
A61B017/068 |
Claims
1. A surgical stapling method, comprising; actuating a surgical
stapling device to deploy one or more surgical staples in a staple
holder; advancing a wedge member caused by actuating of the
surgical stapling device to deploy the one or more surgical staples
in the staple holder; displacing a staple trap caused by advancing
of the wedge member to displace said staple trap from a neutral
position or neutral state to allow deployment of the one or more
surgical staples through the staple holder; further advancing the
wedge member to deploy the one or more surgical staples or
frangibly separate and deploy the one or more surgical staples
until full deployment of the one or more surgical staples is
complete; and further displacing the staple trap caused by further
advancing of the wedge member to return said staple trap back to
its neutral position or neutral state to block deployed but
unsecured staples from falling into the staple holder.
2. The surgical stapling method of claim 1, wherein the deployed
but unsecured staples are staples that are not stapled into target
tissue during staple deployment.
3. The surgical stapling method of claim 1, further comprising:
additionally displacing the staple trap to dislodge and release the
deployed but unsecured staples away from the surgical stapling
device.
4. The surgical stapling method of claim 1, wherein the staple trap
in its neutral position or neutral state blocks deployment of the
one or more surgical staples through the staple holder.
5. The surgical stapling method of claim 1, wherein an arm member
of the staple trap blocks deployment of the one or more surgical
staples when the staple trap is in its neutral position or neutral
state.
6. The surgical stapling method of claim 1, wherein displacing the
staple trap comprises of deflecting the arm member of the staple
trap to unblock deployment of the one or more surgical staples
through the staple holder.
7. The surgical stapling method of claim 6, wherein displacing the
staple trap comprises of deflecting the arm member of the staple
trap without causing movement or substantial movement of the staple
trap.
8. The surgical stapling method of claim 3, wherein additionally
displacing the staple trap to dislodge and release the deployed but
unsecured staples away from the surgical stapling device comprises
of causing movement or substantial movement of the staple trap.
9. The surgical stapling method of claim 8, wherein movement or
substantial movement of the staple trap comprises of lateral
movement of the staple trap.
10. The surgical stapling method of claim 8, wherein movement of
the staple strap causes an arm member to dislodge and release the
deployed but unsecured staples away from the surgical stapling
device.
11. A surgical stapling method, comprising; actuating a surgical
stapling device to deploy one or more surgical staples in a staple
holder; advancing a wedge member caused by actuating of the
surgical stapling device to deploy the one or more surgical staples
in the staple holder; displacing an arm member of a staple trap
caused by advancing of the wedge member to displace said arm member
from a neutral position or neutral state to allow deployment of the
one or more surgical staples through the staple holder; further
advancing the wedge member to deploy the one or more surgical
staples or frangibly separate and further deploy the one or more
surgical staples until full deployment of the one or more surgical
staples is complete; and further displacing the arm member caused
by further advancing of the wedge member to return said arm member
back to its neutral position or neutral state to block deployed but
unsecured staples from falling into the staple holder.
12. The surgical stapling method of claim 11, wherein displacement
of the arm member from its neutral position or neutral state causes
no movement of the staple trap.
13. The surgical stapling method of claim 12, further comprising:
displacing the staple trap to dislodge and release the deployed but
unsecured staples away from the surgical stapling device.
14. The surgical stapling method of claim 13, wherein displacing of
the staple strap causes the arm member to dislodge and release the
deployed but unsecured staples away from the surgical stapling
device.
Description
CROSS-REFERENCE TO RELATED APPLICATION(S)
[0001] This application is a continuation of U.S. patent
application Ser. No. 13/093,815 (attorney docket no. 325), filed
Apr. 25, 2011, which is herein incorporated by reference in its
entirety.
FIELD OF THE INVENTION
[0002] The invention generally relates to a surgical tool and
method, and more specifically to an endocutter.
BACKGROUND
[0003] An endocutter is a surgical tool that staples and cuts
tissue to transect that tissue while leaving the cut ends
hemostatic. An endocutter is small enough in diameter for use in
minimally invasive surgery, where access to a surgical site is
obtained through a trocar, port, or small incision in the body. A
linear cutter is a larger version of an endocutter, and is used to
transect portions of the gastrointestinal tract. A typical
endocutter receives at its distal end a disposable single-use
cartridge with several rows of staples, and includes an anvil
opposed to the cartridge. The surgeon inserts the endocutter
through a trocar or other port or incision in the body, orients the
end of the endocutter around the tissue to be transected, and
compresses the anvil and cartridge together to clamp the tissue.
Then, a row or rows of staples are deployed on either side of the
transection line, and a blade is advanced along the transection
line to divide the tissue.
[0004] During actuation of an endocutter, the cartridge fires all
of the staples that it holds. In known endocutters and linear
staplers, wedges are moved longitudinally, where each wedge
sequentially encounters a plurality of staple drivers during its
travel. Those staple drivers convert the longitudinal motion of the
wedges into vertical motion of the staples, driving the staples
upward into an anvil. The wedges are simply solid pieces of metal
or other material shaped in a way to facilitate contact between the
wedges and the staple drivers. Depending on the amount of tissue
clamped between a cartridge and an anvil of an endocutter, some of
the staples may deploy from the cartridge away from clamped tissue,
such that those staples close but do not close into tissue. Because
the staples are made of biocompatible material such as stainless
steel or titanium, are small compared to the size of bodily
structures, and are closed or generally closed at the completion of
deployment, these staples are simply released into the patient,
where they reside harmlessly just as do the staples that deployed
into tissue.
BRIEF DESCRIPTION OF THE DRAWINGS
[0005] FIG. 1 is a schematic view of an endocutter.
[0006] FIG. 2 is a cross-section view of a trocar port positioned
in a patient.
[0007] FIG. 3 is a perspective view of an exemplary feeder
belt.
[0008] FIG. 4 is a side view of the feeder belt of FIG. 3.
[0009] FIG. 5 is a top view of the feeder belt of FIG. 3.
[0010] FIG. 6 is a perspective view of another exemplary feeder
belt with two rows of staples frangibly connected thereto.
[0011] FIG. 7 is a side view of the feeder belt of FIG. 6.
[0012] FIG. 8 is a top view of the feeder belt of FIG. 6.
[0013] FIG. 9 is a perspective view of an exemplary end effector of
an endocutter that utilizes a feeder belt.
[0014] FIG. 10 is a perspective view of the interior of a staple
holder of the endocutter of FIG. 9.
[0015] FIG. 11 is the perspective view of the interior of a staple
holder of the endocutter of FIG. 9, with feeder belts shown.
[0016] FIG. 12 is a perspective view of a staple holder.
[0017] FIG. 13 is a side view of a wedge base.
[0018] FIG. 14 is a perspective view of the wedge base of FIG.
13.
[0019] FIG. 15 is a perspective view of an active wedge.
[0020] FIG. 16 is a side view of a first exemplary wedge plate.
[0021] FIG. 17 is an end view of a wedge grate.
[0022] FIG. 18 is a side view of a second exemplary wedge
plate.
[0023] FIG. 19 is a perspective view of the active wedge of FIG. 15
at a first position within the staple holder, in a first
configuration, showing a knife.
[0024] FIG. 20 is a top view of the active wedge of FIG. 15 in the
first position of FIG. 18.
[0025] FIG. 21 is a perspective view of the active wedge of FIG. 15
at the first position within the staple holder, in a second
configuration.
[0026] FIG. 22 is an end cross-section view of the active wedge of
FIG. 15 in the second configuration of FIG. 21.
[0027] FIG. 23 is a perspective view of the active wedge of FIG. 15
in a second position within the staple holder, in the second
configuration.
[0028] FIG. 24 is a perspective view of a wedge catch within the
staple holder.
[0029] FIG. 25 is a perspective view of the active wedge of FIG. 15
in the second position within the staple holder, in the first
configuration.
[0030] FIG. 26 is a perspective view of a blood vessel after
transection by an endocutter.
[0031] FIG. 27 is a top view of a first exemplary staple trap.
[0032] FIG. 28 is a perspective view of the staple trap of FIG.
27.
[0033] FIG. 29 is a front view of the staple trap of FIG. 27.
[0034] FIG. 30 is a rear view of the staple holder of FIG. 12.
[0035] FIG. 31 is a detail side view of the staple trap of FIG. 27
adjacent to a staple of FIG. 7.
[0036] FIG. 32 is a detail top view of FIG. 31.
[0037] FIG. 33 is a detail top view of FIG. 31 including the
aperture through an upper surface of the staple holder.
[0038] FIG. 34 is a perspective view of a second exemplary staple
trap.
[0039] FIG. 35 is a top view of the staple trap of FIG. 34.
[0040] FIG. 36 is a front view of the staple trap of FIG. 34.
[0041] FIG. 37 is a perspective view of a third exemplary staple
trap.
[0042] FIG. 38 is a front view of the staple trap of FIG. 37.
[0043] FIG. 39 is a top view of the staple trap of FIG. 37.
[0044] FIG. 40 is a top view of a wedge engaging a staple trap.
[0045] The use of the same reference symbols in different figures
indicates similar or identical items.
DETAILED DESCRIPTION
[0046] Endocutter--Three Staple Rows
[0047] Referring to FIG. 1, an endocutter 2 includes an end
effector 4 attached to a shaft 6, which in turn is attached to a
handle 8. The end effector 4 may be one or more separate components
that are connected to the shaft 6, or may be fabricated integrally
with the distal end of the shaft 6. Referring also to FIG. 2, the
end effector 4 and the shaft 6 may be sized to pass through a
standard trocar port 10 that may be placed through tissue 12 of a
patient. Advantageously, the end effector 4 may be sized to pass
through a trocar port 10 having an opening between 5-10 millimeters
in diameter. Alternately, the endocutter 2 may be used in the
course of conventional open surgery, where a trocar port is not
used. Alternately, the endocutter 2 may be used in the course of
minimally-invasive surgery, where access to the surgical site in
the patient is gained through a mechanism or structure other than a
trocar port, such as the LAP DISC.RTM. hand access device of
Ethicon Endo-Surgery, Inc., or where access to the surgical site in
the patient is gained through an incision or opening in which no
port or other mechanism or structure is placed.
[0048] The trocar port 10 may be a hollow generally-tubular
structure inserted into an incision in tissue 12 of a patient to
hold that incision open and to prevent damage to the tissue 12
defining the incision opening that may result from the motion of
tools and other objects through the incision. The trocar port 10
may be made from plastic or any other suitable biocompatible
material. The trocar port 10 may have a substantially circular
cross section, a substantially oval cross section, or any other
suitable cross section. The particular dimensions of a trocar port
10 depend on the particular procedure to be performed on the
patient, and may be any suitable dimensions. The trocar port 10 may
be coupled to a cutting tool (not shown) through its center that
makes an opening in tissue 12, after which the trocar port 10 is
placed into tissue 12. The cutting tool may be a spike or other
cutting or puncturing device, which is removed from the trocar port
10 when the trocar port 10 is in position in the chest wall. The
combination of a trocar port 10 and a cutting tool is standard in
the art.
[0049] Referring to FIG. 1, the shaft 6 of the endocutter 2 extends
proximally from the end effector 4. The shaft 6 may be flexible or
rigid. The shaft 6 may be articulated in at least one location, if
desired. Optionally, the shaft 6 may include a cutaway, trough or
other feature (not shown) to allow a guidewire (if any) or other
positioning aid that may be used in the surgical procedure to
remain in place during actuation of the endocutter 2.
[0050] The handle 8 may be attached to the proximal end of the
shaft 6, or any other suitable portion of the shaft 6. The shaft 6
may be fabricated integrally with the handle 8. Alternately, the
shaft 6 and the handle 8 may be two separate items that are
connected together in any suitable manner. The handle 8 may include
any mechanism, mechanisms, structure or structures that are
suitably configured to actuate the end effector 4. The handle 8 may
also include a source of stored energy for actuating the end
effector 4. The source of stored energy may be mechanical (such as
a spring), electrical (such as a battery), pneumatic (such as a
cylinder of pressurized gas) or any other suitable source of stored
energy. The source of stored energy, its regulation, and its use in
actuating the end effector 4 may be as described in the U.S. patent
application Ser. No. 11/054,265, filed on Feb. 9, 2005, which is
herein incorporated by reference in its entirety. The handle 8 may
instead, or also, include a connector or connectors suitable for
receiving stored energy from an external source, such as a hose
connected to a hospital utility source of pressurized gas or of
vacuum, or an electrical cord connectable to a power source.
[0051] Referring to FIGS. 3-5, a portion of a feeder belt 16 is
positioned within the end effector 4. The feeder belt 16 may be a
long, narrow, thin strip of material from which one or more staples
18 extend. The feeder belt 16 may be fabricated from stainless
steel, nickel-titanium alloy, or any other suitable metallic or
non-metallic material. The feeder belt 16 is flexible enough, and
strong enough, to be advanced linearly and then redirected around a
nose or other structure in substantially the opposite direction, as
described in greater detail below. Alternately, the feeder belt 16
may be rigid or at least partially rigid, and may be advanced or
retracted substantially linearly without redirection about a
structure.
[0052] Two rows 26 of staples 18 may extend from the feeder belt
16. With such a feeder belt 16, one row 26 of staples 18 may be
located along each side of the feeder belt 16. At least two staples
18 in different rows 26 may be staggered relative to one another.
That is, at a given longitudinal position along the feeder belt 16
at which a staple 18 in one row 26 is attached to the feeder belt
16, the other row 26 does not have a staple 18 attached to the
feeder belt 16. This staggering of the staples 18 promotes
hemostasis in tissue treated with the end effector 4. Alternately,
staples 18 in each row 26 may be aligned with one another, such
that at a given longitudinal position along the feeder belt 16 at
which a staple 18 in one row 26 is connected to the feeder belt 16,
each other row 26 has a staple 18 connected to the feeder belt 16
as well.
[0053] The staples 18 in each row 26 may be substantially evenly
spaced apart from one another. That is, the distance between any
two longitudinally-adjacent staples 18 in a row is substantially
the same. Alternately, at least two longitudinally-adjacent staples
18 in each row 26 may be spaced apart a distance different from the
distance between two other longitudinally-adjacent staples 18. Such
a configuration may be useful where the length of the staple line
is not adjustable. The staple line to be created with the end
effector 4 may be fixed at a particular number of staples 18, and
the staples 18 in each row may be grouped together in groups each
having a length substantially the same as that fixed staple line.
Each group of staples 18 in a row 26 may thus be separated from the
adjacent group of staples 18 by a blank space on the feeder belt
16, where that blank space may have any suitable length.
[0054] Each staple 18 may be shaped in any suitable manner; the
staples 18 may be shaped substantially the same as one another, or
may be shaped differently. As one example, each staple 18 is
generally V-shaped, and has two legs 20 extending from the base of
the V-shape. The base of the V-shape of the staple 18 may be
curved, pointed or otherwise configured. One leg 20 of the staple
18 may be generally straight, and the other leg 20 of the staple 18
may be gently curved. However, the legs 20 may be shaped in a
different manner. For example, both legs 20 may be curved. Further,
each leg 20 may be shaped in the same manner. The staple 18 need
not be symmetrical, but can be fabricated symmetrically if
desired.
[0055] As another example, referring also to FIGS. 6-8, at least
one staple 18 may be shaped as a continuous curve, as may be most
clearly seen in FIG. 26. A distal end of the staple 18 may be
connected to the feeder belt 16, such as via a tab 28 protruding
laterally from the feeder belt 16, such as described above.
However, as used in this document, the term "tab" encompasses any
frangible connection between the staple 18 and the feeder belt 16.
Further, as used in this document, the terms "frangible" and
"frangibly" have their ordinary meaning, which is "breakable." The
staple 18 may extend proximally and downward from the tab 28. Then,
the staple 18 may continue to curve downward, but also curve
distally to form a bump 19. This bump 19 may extend to the
longitudinal position of the tab 28, further distally than the
longitudinal position of the tab 28, or not as far longitudinally
as the tab 28. Then, the staple 18 may continue to curve downward,
but also curve proximally. The staple 18 continues to curve
proximally, then begins to curve upward at an inflection point 21.
The staple 18 then continues to curve upward and proximally until
terminating at a free end 22 at its proximal end.
[0056] One leg 20 of the staple 18 has a free end 22 that may be
characterized as a tissue penetrating tip 22. The tissue
penetrating tip 22 may be sharpened, if desired, to facilitate
penetration of tissue. However, the legs 20 of the staple 18 may
have a cross-section that is small enough that the tissue
penetrating tip 22 need not be sharpened in order to easily
penetrate tissue. The other leg 20 is attached at one end to the
feeder belt 16. Advantageously, that leg 20 is frangibly connected
to the feeder belt 16. Thus, one end of the staple 18 may be
affixed to the feeder belt 16 and the other end of the staple 18
may be free. Alternately, the staple 18 may have three or more legs
20, or may be shaped in any other suitable manner.
[0057] The feeder belt 16 and staples 18 may be fabricated in any
suitable manner. As one example, a flat, thin sheet of material is
laser cut into long strips, after which each strip is laser cut to
form fingers therein that are then bent into the shape of the
staples 18. In this way, the staples 18 and the feeder belt 16 form
an integral structure. However, the feeder belt 16 and staples 18
may be fabricated in any other suitable manner. As one example, the
staples 18 and feeder belt are fabricated separately, and the
staples 18 are then connected to the feeder belt 16 by welding,
adhesive, or any other method that provides a frangible connection
between the staples 18 and the feeder belt 16.
[0058] A frangible connection between the feeder belt 16 and each
corresponding staple 18 may be configured in any suitable manner.
As one example, referring particularly to FIG. 5, each feeder belt
16 may include at least one tab 28 protruding laterally therefrom,
or defined laterally in the center thereof. Alternately, at least
one tab 28 may be oriented differently. Advantageously, the tabs 28
result from laser cutting and subsequent mechanical deformation of
the staples 18 during manufacturing, such that the tabs 28 and
staples 18 are integral with the corresponding feeder belt 16.
However, the tabs 28 and/or staples 18 may be fabricated and
connected to the feeder belt 16 in any other suitable manner. At
least one staple 18 may be attached to a corresponding tab 28 in
any suitable manner. The attachment between a staple 18 and the
corresponding tab 28 may be made in any suitable manner, and the
connection between a staple 18 and the corresponding tab 28 may
have any suitable orientation. As one example, at least one tab 28
is generally rectangular, and the corresponding staple 18 extends
from the proximal edge of that rectangular tab 28. The staple 18
may be separable from the tab 28, at a location generally at the
intersection between the staple 18 and the tab 28. The connection
between a staple 18 and the corresponding tab 28 is strong enough
to hold the staple 18 securely in place relative to the feeder belt
16 prior to deployment, and weak enough to be broken or otherwise
separated from the tab 28 during or after deployment. Optionally, a
staple 18 and/or tab 28 may include a weakened area at or near
their intersection, in order to facilitate separation between the
staple 18 and the feeder belt 16 during or after deployment. The
weakened area may have a reduced cross-sectional area, may be
notched, or otherwise structurally weakened. Alternately, the
weakened area may also, or instead, be physically treated or
otherwise configured to be weaker than the surrounding material,
while having substantially the same physical dimensions as that
surrounding material.
[0059] As shown in FIGS. 3-5, the staples 18 are in an initial
configuration prior to being deployed. In the initial
configuration, the staples 18 do not substantially contact one
another. Alternately, at least two of the staples 18 may contact
one another in the initial configuration. The staples 18 each may
lie substantially in a single plane. That is, the staple 18 may be
shaped such that a single plane extends through and substantially
bisects the staple 18. Alternately, at least one staple 18 does not
lie substantially in a single plane. At least one staple 18 may be
positioned in a plane that is generally perpendicular to the feeder
belt 16. Alternately, at least one staple 18 may be positioned in a
plane that is angled differently relative to the feeder belt 16.
One or more rows 26 of staples 18 are connected to the feeder belt
16. Each row 26 of staples 18 is the group of staples 18 positioned
at substantially the same lateral location relative to the
longitudinal centerline of the feeder belt 16, and each row 26 of
staples 18 is oriented generally longitudinally. The feeder belt 16
may form a continuous loop, or may have a discrete beginning and
end that are not attached to one another. Alternately, more or
fewer rows 26 of staples 18 may be attached to the feeder belt 16.
Each row 26 may extend along part, or all, or the length of the
feeder belt 16. Different rows 26 may extend different lengths
along the feeder belt 16.
[0060] Staples 18 in two or more different rows 26 along a single
feeder belt 16 may be arranged in any suitable manner relative to
one another. As one example, staples 18 in two or more different
rows 26 along a single feeder belt 16 may be staggered relative to
one another. That is, at a given longitudinal position along a
single feeder belt 16 at which a staple 18 in one row 26 is
attached to the feeder belt 16, at least one other row 26 does not
have a staple 18 attached to that feeder belt 16. This staggering
of the staples 18 promotes hemostasis in tissue treated with the
end effector 4. Alternately, staples 18 in two or more of the rows
26 along a single feeder belt 16 may be aligned with one another,
along at least part of the length of the rows 26, such that at a
given longitudinal position along the feeder belt 16 at which a
staple 18 in one row 26 is attached to the feeder belt 16, each
other row 26 has a staple 18 attached to the feeder belt 16 as
well. Alternately, staples 18 in two or more rows 26 along a single
feeder belt 16 may be arranged differently along different
longitudinal portions of that feeder belt 16. Staples 18 may be
arranged relative to one another in the same manner, or
differently, on different feeder belts 16 of the endocutter 2.
[0061] The staples 18 in each row 26 may be substantially evenly
spaced apart from one another. That is, the distance between any
two longitudinally-adjacent staples 18 in a row may be
substantially the same. Alternately, at least two
longitudinally-adjacent staples 18 in each row 26 may be spaced
apart a distance different from the distance between two other
longitudinally-adjacent staples 18. Such a configuration may be
useful where the length of the staple line is not adjustable. The
staple line to be created with the end effector 4 may be fixed at a
particular number of staples 18, and consequently the staples 18 in
each row may be grouped together in groups each having a length
substantially the same as that fixed staple line. If so, each group
of staples 18 in a row 26 may be separated from a adjacent group of
staples 18 by a blank space on the feeder belt 16, where that blank
space may have any suitable length. Advantageously, no staples 18
extend from, or into an area bounded by, the blank space of the
feeder belt 16.
[0062] Referring also to FIG. 9, the end effector 4 may include a
staple holder 30 and an anvil 32. The anvil 32 may be movable about
a pin 34 of other structure relative to the staple holder 30 to
clamp and/or compress tissue therebetween in any suitable manner.
The anvil 32 may include standard staple bending features defined
therein to facilitate closure of the staples 18. Alternately,
staple bending features may be omitted from the anvil 32. The anvil
32 may be pivotable relative to the staple holder 30. In this way,
the distal end of the anvil 32 may be spaced apart from and
positioned above the staple holder 30 in a first, initial position
prior to clamping tissue, while the proximal end of the anvil 32
may be connected to the staple holder 30. Clamping of tissue by
between the staple holder 30 and the anvil 32 may be performed in
any suitable manner, and example of which is set forth in U.S.
patent application Ser. No. 12/612,614, filed on Nov. 4, 2009,
which is herein incorporated by reference in its entirety.
Alternately, the anvil 32 may be connected to and/or movable
relative to the staple holder in a different manner. Alternately,
the staple holder 30 may be movable relative to the anvil 32.
Alternately, the staple holder 30 and the anvil 32 may be movable
relative to one another. The distal end of the staple holder 30 and
the distal end of the anvil 32 may be blunt, in order to prevent
inadvertent engagement of tissue with the end effector 4 during
insertion of the end effector 4 into the patient and motion of the
end effector 4 to a treatment site. Advantageously, the staple
holder 30 is fixed to a remainder of the end effector 4 and/or the
shaft 6, and is not detachable therefrom. As set forth in greater
detail below, the staple holder 30 may be fired multiple times
without being withdrawn from the patient, such that there is no
need to withdraw the end effector 4 from the patient after each
firing of staples 18 in order to replace a staple cartridge or
other component. Nevertheless, if desired the staple holder 30 may
be detachable from a remainder of the end effector 4 and/or the
shaft 6; the end effector 4 may be detachable from the shaft 6;
and/or the shaft 6 may be detachable from the handle 8.
[0063] The staple holder 30 may include any suitable components.
Referring also to FIG. 10, the staple holder 30 may include a
feeder belt guide 40. The feeder belt guide 40 may be configured in
any suitable manner. The feeder belt guide 40 may be located in
proximity to the distal end of the staple holder 30. The feeder
belt guide 40 may include one or more reversal wheels 42 that
rotate about a reversal axle 44. Optionally, one or more reversal
wheels 42 may include teeth 46 that engage corresponding apertures
51 in a feeder belt 16, as described in greater detail below. The
reversal axle 44 may be held in place via fixation to a lateral
part of the staple holder 30, which is omitted from FIG. 7 for
clarity. The bottom inner surface 49 of the staple holder 30 may
include one or more generally-longitudinal channels 48 defined
therein. A step 50 may be defined on the lateral side of one or
more channels 48, and may extend along some or all of the length of
each channel 50. Each step 50 may be located slightly above and
generally parallel to the lower surface of the corresponding
channel 48. As another example of feeder belt guide 40, a feeder
belt guide may be used as described in commonly-assigned U.S. Pat.
App. Publication No. 2009/0065552 of Knodel et. al., published on
Mar. 12, 2009, (the "Endocutter Document"), which is herein
incorporated by reference in its entirety.
[0064] As used in this document, the term "upper" and similar terms
of orientation mean a direction that is both perpendicular to the
longitudinal centerline of the staple holder 30 and oriented toward
the anvil 32. The term "lower" and similar terms of orientation
refer to the direction opposite to the "upper" direction defined
immediately above. The terms "distal" and "proximal" are used in
the same manner as is standard to those of ordinary skill in the
art, and refer to opposite directions along the longitudinal
centerline of the staple holder 30, as illustrated in FIG. 10. The
distal direction is oriented toward the free end of the staple
holder 30, and the proximal direction is opposite to the distal
direction.
[0065] Referring also to FIG. 11, the end effector 4 may include
one or more feeder belts 16. In this way, staples 18 can be
deployed on either side of an incision or transection to be made in
tissue. Alternately, the end effector 4 may include only one feeder
belt 16, or three or more feeder belts 16. The feeder belts 16 may
be independent of one another, or connected to one another in any
suitable manner. A feeder belt 16 may be routed around each
reversal wheel 42. If provided, teeth 46 in one or more reversal
wheels 42 may engage apertures 50 in a corresponding feeder belt or
belts 16. Each feeder belt 16 may be routed along a path that
starts generally straight and in the distal direction, then is
curved along the surface of the corresponding reversal wheel 42,
and then is generally straight and in the proximal direction. That
is, the reversal wheel 42 changes the direction of motion of the
corresponding feeder belt 16 from generally distal to generally
proximal.
[0066] The feeder belts 16 need not each contain the same number of
staples 18. Referring to FIG. 12, a plurality of apertures 62 may
be defined through the upper surface 60 of the staple holder 30,
where the apertures 62 allow for deployment of staples 18 through
the upper surface 60. The apertures 62 may be arranged into one or
more longitudinally-oriented rows. As seen in FIG. 9, six
longitudinally-oriented rows of apertures 62 may be provided. A
knife slot 64 may be defined through the upper surface 60 of the
staple holder 30 as well to allow for passage of a knife, as
described in greater detail below. The rows of apertures 62 may be
arranged symmetrically about the knife slot 64 as seen in FIG. 9,
where three rows of apertures 62 are provided on each side of the
knife slot 64. However, the apertures 62 may be arranged
asymmetrically or otherwise arranged about the knife slot 64. Where
three rows of apertures 62 are present on each side of the knife
slot 64, two feeder belts 16 may be utilized, as seen in FIG. 11.
If so, staples 18 may extend at an angle from each of two lateral
edges of one feeder belt 16a, and staples 18 may extend at an angle
from only one lateral edge of an adjacent feeder belt 16b. As
another example, two identical feeder belts 16 may be provided,
each of which includes staples 18 that extend at an angle from each
of two lateral edges of the feeder belt 16, but staples 18 are only
deployed from both lateral edges of one feeder belt 16; staples 18
are only deployed from one edge of the other feeder belt 16. An
advantage of doing so is simplicity of manufacture, in that the
manufacturer only need stock and track one type of feeder belt 16,
rather than two separate feeder belts 16 each having a different
number of staples 18.
[0067] Referring to FIGS. 13-14, a wedge base 70 forms part of an
active wedge, as described in greater detail below. The wedge base
70 includes one or more bulkheads 72. Referring also to FIG. 22,
each bulkhead 72 is sized to fit underneath a corresponding feeder
belt 16. Each bulkhead 72 has a width generally similar to the
width of the corresponding feeder belt 16. In this way, each
bulkhead 72 has a width that allows the bulkhead 72 to slide
longitudinally along a corresponding feeder belt 16 between the
staples 18 affixed to the feeder belt 16. Referring back to FIGS.
13-14, as one example, the bulkheads 72 may be arranged into two
groups of two, where each group is laterally spaced from the other
a distance greater than the distance between the bulkheads 72 in a
single group. Each bulkhead 72 may have an upper surface 74. The
upper surface 74 may contact, or be spaced apart vertically from,
the corresponding feeder belt 16. Each bulkhead 72 may have a lower
surface 76. The lower surface 76 may be generally parallel to the
upper surface 74. Alternately, the lower surface 76 may be shaped
and/or oriented in a different manner. Each bulkhead 72 may have a
front surface 78, which may take any suitable shape. As one
example, the front surface 78 may be angled upward in the proximal
direction. Similarly, each bulkhead 72 may have a rear surface 80,
which may take any suitable shape. As one example, the rear surface
80 may be angled downward in the proximal direction.
[0068] A channel 82 may be defined in each lateral side of each
bulkhead 72. The channels 82 allow for motion of a wedge grate
relative to the wedge base 70, as described in greater detail
below. The channel 82 may have any suitable shape. As one example,
the distal end 84 of the channel 82 is also the lowest end of the
channel 82. The channel 82 may include a central segment 86 that is
angled upward in the proximal direction from the distal end 84. The
distal end 84 may extend a short distance distal to the distal end
of the central segment 86, and that distal end 84 may extend
generally longitudinally. In this way, the central segment 86 is
angled relative to the distal end 84. At the upper, proximal end of
the central segment 86, a detent 88 may be positioned. That is, the
channel 82 defines a detent at its most proximal location. The
detent 88 may extend a short distance proximal to the proximal end
of the central segment 86, generally longitudinally. Above the
detent 88, the upper end of the channel 82 may include an insertion
aperture 89.
[0069] The wedge base 70 may include a boss 90. The boss 90 may be
located at or near the proximal end of the wedge base 70, generally
along the longitudinal centerline thereof. Alternately, the boss 90
may be located at any suitable position on the wedge base 70. The
boss 90 may be positioned proximal to the bulkheads 72, or may be
positioned differently relative to the bulkheads 72. Optionally,
the wedge base 70 may include a knife mount 92. The knife mount 92
to be located at or near the distal end of the wedge base 70,
generally along the longitudinal centerline thereof. Alternately
the knife mount 92 may be located at any suitable position on the
wedge base 70. The knife mount 92 be positioned distal to the
bulkheads 72, or may be positioned differently relative to the
bulkheads 72. The wedge base 70 may include one or more return arms
94. Each return arm 94 may be oriented generally longitudinally,
and may be cantilevered proximally from a part of the lower surface
76 of the wedge base 70. In this way, the proximal end of the
return arm is movable vertically at its proximal end. At the
proximal end of the return arm 94, a tooth 96 extends downward. The
proximal face of the tooth 96 may be a substantially vertical plane
98, and the distal face of the tooth 96 may be a substantially
planar surface 99 angled downward in the proximal direction.
[0070] Referring also to FIG. 15, an actuation band 100 is
connected to the boss 90. Advantageously, the actuation band 100 is
fixed to the boss 90 in any suitable manner. Alternately the
actuation band 100 may be removable from the boss 90. The actuation
band 100 may have any suitable shape, and may be fabricated from
any suitable material, such as but not limited to stainless steel.
As one example, the actuation band 100 may be generally rectangular
in cross-section, where the lateral width of the actuation band 100
spans a lesser distance than the vertical height of the actuation
band 100. In this way, the actuation band 100 may have some lateral
flexibility to allow it to pass through an articulation in the
shaft 6, while still providing vertical stiffness. The actuation
band 100 is axially stiff enough for it to both push the wedge base
70 distally and pull the wedge base 70 proximally. The actuation
band 100 may extend from the wedge base 70 through the entirety of
the shaft 6 into the handle 8.
[0071] Referring also to FIGS. 16-17, at least one wedge grate 110
is movably connected to the wedge base 70. Each wedge grate 110
includes at least one wedge plate 112. The wedge plates 112 may be
substantially planar, and substantially parallel to one another
within the same wedge grate 110. A cross pin 114 may connect the
distal ends of the different wedge plates 112 of the wedge grate
110. The cross pin 114 may be generally cylindrical. The cross pin
114 may have any other suitable shape; for example, a rectangular
or triangular solid. As described in greater detail below, at least
one wedge plate 112 sequentially contacts staples 18 along a
longitudinal row along a feeder belt 16, first deforming a staple
18 and then breaking that staple 18 from the feeder belt 16. Each
wedge plate 112 may have any suitable shape. As one example,
referring to FIG. 16, a wedge plate 112 may include an encounter
surface 116, a deformation surface 118, and a separation surface
120. The encounter surface 116 may be substantially vertical.
Proximal to the encounter surface 116, the deformation surface 118
may extend upward in the proximal direction, where the deformation
surface 118 is substantially a straight line. The surfaces 116, 118
may be immediately adjacent to one another, or maybe longitudinally
separated any suitable distance. Proximal to the deformation
surface 118, the separation surface 120 may extend further upward
in the proximal direction. The surfaces 118, 120 may be immediately
adjacent to one another, or maybe longitudinally separated any
suitable distance. As another example, referring to FIG. 17, the
encounter surface 116 may extend vertically a shorter length than
the encounter surface 116 of FIG. 16. The deformation surface 118
may be smoothly curved, and may be a convex surface. As another
example, each wedge plate 112 may have any other suitable shape.
The wedge plates 112 in a single wedge grate 110 may all have
substantially the same shape. Alternately, at least one wedge plate
112 within a wedge grate 110 they be shaped differently than at
least one other wedge plate 112.
[0072] Each wedge plate 112 has at least one pin 122 extending
therefrom. Each pin 122 is received in a corresponding channel 82
in the wedge base 70. During assembly, the pins 122 may be inserted
into the corresponding insertion apertures 89 of the channels 82.
Advantageously, each bulkhead 72 of the wedge base 70 includes
channels 82 on both lateral sides thereof. Wedge plates 112 may be
positioned lateral to each lateral side of each bulkhead 72. The
term "active wedge" is defined to mean the combination of the wedge
base 70 with at least one wedge grate 110 movably connected
thereto. Referring to FIG. 15, where two groups of two bulkheads 72
are utilized, two wedge grates 110 may be utilized, where each
wedge grate 110 is associated with a corresponding group of two
bulkheads 72. One wedge plate 112 may be positioned laterally
inward from the innermost lateral side of the innermost bulkhead
72; another wedge plate 112 may be positioned between the bulkheads
72 in the same group, and the third wedge plate 112 may be
positioned laterally outward from the outermost lateral side of the
outermost bulkhead 72.
[0073] Referring to FIGS. 14 and 19, a knife 124 may be connected
to the knife mount 92 of the wedge base 70, or to any other
suitable portion of the wedge base 70. The knife 124 may have a
sharp edge 126 that is substantially vertical and that is at the
distal edge of the knife 124. Alternately, the sharp edge 126 may
be shaped and/or oriented differently. Optionally, an I-beam head
128 may be positioned at the top of the knife 124, or at any other
suitable location on the knife 124. The I-beam head 128 may be
received in a corresponding cavity within the anvil 32, and may
slide along that cavity to facilitate clamping.
[0074] A proximal wedge catch 130 may be fastened to the bottom
inner surface 49 of the staple holder 30. The proximal wedge catch
130 may be a wire or wire spring that slopes upward in the proximal
direction to a peak 132, then slopes downward to a proximal end
that is lower than the peak 132. The proximal wedge catch 130 may
be generally U-shaped, or may define a closed perimeter. The distal
end of the proximal wedge catch 130 may be held in a notch 133 in
the bottom inner surface 49 of the staple holder 30. Referring also
to FIG. 24, distal to the proximal wedge catch 130, in proximity to
the distal end of the staple holder 30, a distal wedge catch 134
may be fastened to the bottom inner surface 49 of the staple holder
30. The distal wedge catch may be a wire or wire spring that slopes
upward in the distal direction to a peak 136, then slopes downward
to a distal end 138 that is lower than the peak 136. The distal
wedge catch 134 may be generally U-shaped, or may define a closed
perimeter. The proximal end of the distal wedge catch 134 may be
held in a notch 139 in the bottom inner surface 49 of the staple
holder 30.
[0075] Staple Trap
[0076] FIGS. 27-29 show an exemplary staple trap 200 may be
utilized in the staple holder 30. The staple trap 200 may be
utilized whether an active wedge 71 or a conventional wedge is used
to deploy the staples 18. The staple trap 200 may include a strip
202 that may be a long, rectangular piece that may be substantially
thinner than it is high or long, as seen most clearly in FIG. 28.
In this way, the strip 202 may be considered to define or lie in a
plane, where that plane bisects the thinnest dimension of the strip
202. The strip 202 may be rigid, or may be flexible. If the strip
202 is flexible, it may be held rigid by contact between the strip
202 and the staple holder 30, or in any other suitable manner. The
strip 202 may be a portion of the staple trap 200 spaced
longitudinally apart from the distal and/or proximal end of the
staple trap 200. The strip 202 may be shorter in height in the
vertical direction than a portion of the staple trap 200 located
distal and/or proximal to the strip 202. One or more fingers 206
may extend upward from the strip 202. At least one finger 206 may
be generally rectangular in shape as viewed from the side.
Alternately, one or more fingers 206 may be shaped differently or
extend in a different direction from the strip 202. An arm 204 may
extend generally in the proximal direction from each finger 206.
Alternately, at least one arm 204 may extend generally in the
distal direction, or any other suitable direction, from the
corresponding finger 206. At least one arm 204 may extend directly
from the strip 202 or from a part of the staple trap 200 other than
the strip 202.
[0077] At least one arm 204 may be curved at least partially out of
the plane defined by the strip 202. This curvature may be smooth,
or may be defined by a number of straight lines that collectively
approximate a smooth curve. Referring to FIGS. 27 and 29, an
example of curvature is shown. The arm 204 may extend proximally
from a corresponding finger 206. Moving in the proximal direction,
the arm 204 may curve in a first lateral direction relative to the
plane of the strip 202. The curvature may continue to a peak 208
that is the point having the furthest distance laterally from the
strip 202. Moving in the proximal direction from the peak 208, the
curvature of the arm 204 may then continue in the opposite
direction. The arm 204 may cross the plane of the strip 202, such
that its proximal end 210 is located on the other lateral side of
the strip 202 from the peak 208 of the arm 204. Alternately, the
proximal end 210 of the arm 204 may be located on the same side of
the strip 202 as the peak 208.
[0078] The staple trap 200 may be fabricated from any suitable
material, in any suitable manner. As one example, the staple trap
200 may be fabricated from stainless steel. As another example, the
arms 204 and strip 202 may be fabricated by stamping, laser
cutting, or any other suitable manufacturing method.
[0079] Referring to FIGS. 10 and 30, the channels 48 in the staple
holder 30 may be a lower section of a cavity 212 defined generally
longitudinally in the staple holder 30. The staple holder 30 may
contain two cavities 212, or any other suitable number. Each cavity
may include two lateral walls 214 and an upper surface 216.
Advantageously, against each lateral wall 214 a staple trap 200 is
positioned. Each staple trap 200 may be held against the
corresponding lateral wall 214, affixed to the corresponding
lateral wall 214, or in any suitable way positioned against the
corresponding lateral wall 214.
[0080] A feeder belt 16 may be positioned against or in proximity
to the upper surface 216 of the cavity 212, with the staples 18
positioned against the staple traps 200. The arms 204 of each
staple trap 200 may be positioned in any suitable manner relative
to the staples 18 of the corresponding staple trap 200. As one
example, referring to FIGS. 7 and 27-29, in an initial pre-firing
configuration each arm 204 of the staple trap 200 is in a neutral
position. The "neutral position" of each arm 204 is the position
the arm 204 assumes when substantially free from the action of
externally applied forces. Referring also to FIGS. 31-33, when an
arm 204 is in the neutral position, the peak 208 of that arm 204
may be located between the legs 20 of the staple 18 and above the
inflection point 21. The peak 208 may extend laterally outward
further than the staple 18 itself, as seen in FIG. 32, but need not
do so. As seen in FIG. 33, in the neutral position the arm 204 is
directly underneath a corresponding aperture 62 defined through the
upper surface 60 of the staple holder 30. In order to deploy the
staple 18 through the aperture 62, the arm 204 moves out of the
way, as described in greater detail below. As another example, in
an initial pre-firing configuration, at least one staple 18 is
positioned adjacent to and in contact with a corresponding arm 204,
such that at least one staple 18 contacts and deflects the
corresponding arm 204 laterally out of the neutral position in the
initial, pre-firing configuration. If so, each such arm 204 may be
in a position that is not directly underneath the corresponding
aperture defined through the upper surface 60 of the staple holder
30.
[0081] Referring to FIGS. 34-36, another exemplary staple trap 200
is shown. The staple trap 200 and strip 202 may be configured
substantially as described above. However, in FIGS. 34-36 the
fingers 206 are omitted, and the arms 204 extend directly from the
strip 202. Each arm 204 may be substantially a parallelogram, where
each parallelogram is curved laterally toward the distalmost,
uppermost corner of each arm. Alternately, each arm 204 may be
substantially triangular in shape. The lateralmost corner of each
arm 204 may be referred to as the peak 208 of that arm 204. This
staple trap 200 may be positioned in the staple holder 30 in
substantially the same manner as described above.
[0082] Referring to FIGS. 37-39, another exemplary staple trap 200
is shown. The staple trap 200 and strip 202 may be configured
substantially as described above. However, in FIGS. 37-39 the
fingers 206 are omitted, and the arms 204 extend directly from the
strip 202. Each arm 204 may be substantially a trapezoid, where
each trapezoid is curved laterally toward the distalmost, uppermost
corner of each arm. The lateralmost corner of each arm 204 may be
referred to as the peak 208 of that arm 204. This staple trap 200
may be positioned in the staple holder 30 in substantially the same
manner as described above.
[0083] Operation
[0084] Referring to FIG. 2, at least one trocar port 10 may be
inserted into an opening in tissue 12 of a patient 14. Where a
trocar port 10 includes a cutting tool (not shown) such as a spike,
that cutting tool makes an opening in tissue 12, after which the
trocar port 12 is placed in tissue. The cutting tool may be removed
from the trocar port 10 after the trocar port 10 is in position in
tissue 12. Alternately, an opening in tissue 12 may be made first
with a separate tool, and the trocar port 10 is then placed in that
opening. Multiple trocar ports 10, having the same or different
cross-sectional shapes and/or areas, may be placed in the patient
14. The tissue 12 may be the chest wall of the patient 14, thereby
providing access to the thoracic cavity. However, the tissue 12 may
be the abdominal wall or any other suitable tissue in the patient
14. Alternately, the trocar port or ports 10 are not used, and
access to the surgical site is gained in another manner, such as
described above.
[0085] Referring also to FIGS. 1 and 9, the user of the endocutter
2, a medical professional such as a surgeon, receives and possesses
the endocutter 2. "Receiving" the endocutter 2 means that the user
takes the endocutter 2 in hand, either directly from out of its
package, or indirectly via a nurse, medical technician or other
person. The end effector 4 of the endocutter 2 may be introduced
into the patient 14 through one of the trocar ports 10. Referring
to FIG. 9, the end effector 4 may be inserted into the patient 14
in a closed configuration. At least part of the shaft 6 of the
endocutter 2 may follow the end effector 4 into the patient 14.
Alternately, the trocar port or ports 10 are not used, and the
endocutter 2 is used during a conventional open surgical procedure
or is introduced into the patient 14 directly through an incision
in tissue 12. The end effector 4 is positioned by the user at a
surgical site. As one example, referring also to FIG. 26, a
surgical site is located on a blood vessel 148 which is to be
transected. For clarity, this document describes the operation of
the endocutter 2 for transection of a blood vessel 148. However,
the use of the endocutter 2 is not limited to blood vessel
transection; the endocutter 2 may be used to perform any other
suitable procedure at any other surgical site in the body. For
example, the endocutter 2 may be used to transect a bile duct, to
remove a diseased appendix, to transect gastrointestinal tissue, to
remove a diseased lobe of a lung or liver, and/or to transect soft
tissue or organs.
[0086] As set forth in the Endocutter Document, at least the distal
end of the anvil 32 is initially spaced apart from the staple
holder 30, such that the end effector 4 is open. The end effector 4
is advanced over the blood vessel 148 to be transected, until the
entire diameter of the blood vessel 148 is located between the
anvil 32 and the staple holder 30. Advantageously, the blood vessel
148 is substantially at a right angle to the anvil 32 and the
staple holder 30. However, the blood vessel 148 may be oriented at
any other suitable angle relative to the anvil 32 and the staple
holder 30. The end effector 4 is then closed, by moving the anvil
32 closer to the staple holder 30, such that the blood vessel 148
is compressed between the anvil 32 and the staple holder 30. Such
closure of the end effector 4 may be accomplished as set forth in
the Endocutter Document. Closure of the end effector 4 may be
performed by actuating one or more controls on the handle 8 of the
endocutter 2, and/or by releasing energy stored in the handle 8.
After the end effector 4 has been closed, the tissue to be treated
is held securely by, and affirmatively controlled by, the end
effector 4.
[0087] Referring to FIGS. 18 and 20, the active wedge 71 is in an
initial position, in a first configuration. The initial position of
the active wedge 71 in the staple holder 30 is proximal to the
apertures 62 therein, and proximal to the staples 18 to be
deployed. In the first position, the knife 124 may extend through
the knife slot 64, such that part of the sharp edge 126 is located
above the knife slot 64 and part of the sharp edge 126 is located
below the knife slot 64; advantageously the sharp edge 126 is
located proximal to tissue 148 and does not contact tissue 148 in
the first position. The "first configuration" refers to a position
of each wedge grate 110 relative to the wedge base 70. The first
configuration also may be referred to as the "wedge down"
configuration. In the first configuration, the entirety of the
wedge grate 110 is positioned below the upper surface 74 of the
wedge base 70. Also in the first configuration, the cross pin 114
of each wedge grate 110 is positioned proximal to the peak 132 of
the proximal wedge catch 130. Further, the cross pin 114 of each
wedge grate 110 may be positioned at the proximal end of a
corresponding channel 48 defined in the bottom inner surface 49 of
the staple holder 30. Advantageously, referring also to FIG. 10, at
least one cross pin 114 rests on at least one step 50 defined in a
channel 48. In this way, the cross pin 114 may be vertically spaced
above the bottom inner surface 49 of the staple holder 30.
Alternately, at least one cross pin 114 may slide along the bottom
of a corresponding channel 48. Advantageously, when the active
wedge 71 is in the first position and the first configuration, the
cross pin 114 is held between the peak 132 of the proximal wedge
catch 130 and a proximal wall 140 of the corresponding channel 48,
where the proximal wall 140 extends inward from the outermost
portion of the laterally-outermost step 50 and thereby prevents
proximal motion of the cross pin 114 beyond that proximal wall 140.
Referring also to FIGS. 13 and 16A, in the first configuration,
each pin 122 extending from a corresponding wedge plate 112 may be
positioned at the distal end 84 of the corresponding channel 82
defined in a bulkhead 72 of the wedge base 70. Further, referring
also to FIG. 22, an upper channel surface 142 is spaced vertically
from the bottom inner surface 49 of the staple holder 30, and
prevents the cross pin 114 from moving substantially upward. That
is, aside from a small amount of play to allow the cross pin 114 to
slide longitudinally, the cross pin 114 is vertically constrained
between the upper channel surface 142 and the step 50.
[0088] The user then actuates one or more controls on the handle 8
to actuate the end effector 4. As a result, the actuation band 100
is moved distally, by any suitable mechanism or method. As one
example, the proximal end of the actuation band 100 may extend near
to or into the handle 8, and a mechanism within the handle 8 urges
the actuation band 100 distally. The mechanism may be actuated by a
release of energy stored within the handle 8. A mechanism for
moving a actuation band 100 linearly is standard; any suitable
mechanism or mechanisms may be utilized. Distal motion of the
actuation band 100 in turn urges the active wedge 71 distally, due
to the attachment between the actuation band 100 and the boss
90.
[0089] As the active wedge 71 is urged distally, each cross pin 114
of a wedge grate 110 is urged distally as well. However, each peak
132 of the proximal wedge catch 130 resists the distal motion of
the corresponding cross pin 114, because each peak 132 is distal to
and in the path of the cross pin 114, which in turn is constrained
to move substantially longitudinally and not vertically.
Consequently, each cross pin 114 does not immediately ride up over
the corresponding peak 132, but rather is pushed longitudinally
against the proximal wedge catch 130, which acts against the distal
force applied to the active wedge 71. As a result, each cross pin
114 is held in place while the wedge base 70 advances distally.
This relative motion between the cross pin 114 and the wedge base
70 urges each pin 122 extending from a corresponding wedge plate
112 out of the distal end of the corresponding channel 82 in the
wedge base 70, referring also to FIG. 13. Each pin 122 then slides
up the central segment 86 of the channel 82, until that pin 122 is
caught by and stops in the detent 88 in the channel 82. As a result
of this motion of the pins 122, the wedge plate 112 and thus the
wedge grate 110 as a whole moves upward relative to the wedge base
70 to the second configuration.
[0090] Referring to FIGS. 21-22, the "second configuration" means
that at least part of at least one wedge plate 112 is positioned
above the upper surface 74 of the wedge base 70. The second
configuration may be referred to as the "wedge up" configuration as
well. Advantageously, in the second configuration, at least part of
the separation surface 120 of each wedge plate 112 is positioned
above the upper surface 74 of the wedge base 70. The wedge base 70
is still substantially positioned at the initial position, and each
cross pin 114 is still located between the corresponding peak 132
of the proximal wedge catch 130 and the proximal wall 140 of the
corresponding channel 48. The actuation band 100 continues to apply
a force in the distal direction to the active wedge 71. Because the
wedge grate 110 can no longer move relative to the wedge base 70,
that distal force applied to the active wedge 71 causes each
crossbar 114 to push the proximal end of the proximal wedge catch
130 downward. This may be facilitated by a distally-sloped upward
bend or angle in the proximal wedge catch 130 proximal to each
peak. That is, the force applied to the proximal wedge catch 130 by
the active wedge 71 grows large enough to push the proximal wedge
catch 130 out of the path of motion of the wedge grate 110.
[0091] At that time, the active wedge 71 is free to move distally,
sliding longitudinally along the channels 48 defined in the bottom
inner surface 49 of the staple holder 30. Distal motion of the
active wedge 71 causes deployment of the staples 18. For clarity,
motion of a single wedge plate 112 to deploy one or more staples 18
in a corresponding row 26 is described.
[0092] Referring also to FIGS. 3-5 and 6-8, the active wedge 71 is
initially proximal to the staples 18 in the corresponding
generally-linear row 26, and the path of motion of each wedge plate
112 may be generally parallel to or collinear with the
corresponding row 26. Referring also to FIGS. 16-17, as the wedge
plate 112 moves distally, the encounter surface 116 of the wedge
plate 112 contacts the most-proximal staple 18 in the corresponding
row. Contact between the encounter surface 116 and the staple 18
applies force to the staple 18. Because the encounter surface 116
is substantially vertical, that force applied to the staple 18 is
exerted in substantially a distal, longitudinal direction
substantially normal to the encounter surface 116. This force is
applied to the leg 20 or portion of the smooth curve of the staple
18 that is located closer to the tab 28 than to the free end 22. As
a result, the distal force applied to the staple 18 results in a
moment about the tab 28 or other frangible connection that connects
the staple 18 to the feeder belt 16. The moment acts on the staple
18 to rotate the staple 18 about the tab 28, such that the free end
22 of the staple 18 moves upward, out of the corresponding aperture
62 in the upper surface 60 of the staple holder 30 and into the
blood vessel 148 or other tissue clamped between the anvil 32 and
the staple holder 30. During motion of the active wedge 71, the
feeder belt 16 may be held substantially in place.
[0093] Referring also to FIGS. 27-29, as the active wedge 71 moves,
it encounters the peak 208 of the arm 204 of the staple trap 200
closest to the most-proximal staple 18. As the active wedge 71
slides distally, it exerts a force on the arm 204, because at least
the peak 208 of the arm 204 is in the path of the active wedge 71.
Because the arm 204 is curved, that curvature allows the active
wedge 71 to deflect the arm 204 laterally sideways. The arm 204
begins to deflect laterally away from its neutral position. When
the active wedge 71 has moved to a position in which the peak 208
of the arm 204 is in contact with the lateral side of the active
wedge 71, the arm 204 has reached its position of maximum lateral
deflection, as seen in FIG. 40, and will remain in that position of
maximum lateral deflection as long as the peak 208 contacts the
lateral side of the active wedge 71. In this position of the arm
204, the arm 204 has been moved out of the corresponding staple 18
such that the staple 18 is free to be deformed and separated as
described in greater detail below. Alternately, where the staple 18
has already deflected the corresponding arm 204 out of the neutral
position by contact between the staple 18 and the arm 204, the
active wedge 71 may, but need not, contact the arm 204 during its
approach to the staple 18.
[0094] The active wedge 71 continues to slide distally, such that
the encounter surface 116 of the wedge plate 112 exerts a force on
the staple 18 that causes a moment about the tab 28. As the staple
18 rotates about the tab 28, and the wedge plate 112 continues to
move distally, the lowest point of the staple 18 moves upward. When
the lowest point of the staple 18 moves above the encounter surface
116, the deformation surface 118 begins to contact the staple 18.
The deformation surface 118 is angled and/or curved upward in the
proximal direction such that contact between that deformation
surface 118 and the staple 18 continues to cause a moment about the
tab 28 such that the staple 18 continues to rotate upward about the
tab 28. As the free end 22 of the staple 18 rotates upward, it
penetrates completely through the blood vessel 148 and then
contacts the lower surface of the anvil 32. Optionally, a standard
staple bending feature may be defined in the anvil 32 at the
location where the free end 22 of the staple 18 contacts the anvil
32. As the free end 22 of the staple 18 contacts the anvil 32, the
rotation of the staple 18 about the tab 28 results in motion of the
free end 2 both upward and distally. However, contact between the
free end 22 of the staple 18 and the anvil 32 prevents further
upward motion of the free end 22 of the staple 18. As a result, the
free end 22 of the staple 18 moves distally along the lower surface
of the anvil 32 and/or staple bending feature defined thereon. This
motion may bend or deform the leg 20 of the staple 18 associated
with the free end 22, closing the staple 18 to form a D-shape or
other suitable shape. The staple 18 may be fabricated from a
plastically-deformable material such as stainless steel, such that
deformation of the staple 18 may be plastic deformation.
Alternately, at least part of at least one staple 18 may be
elastically deformable or superelastically deformable.
[0095] As the active wedge 71 continues to move distally, the
separation surface 120 of the wedge plate 112 slides distally
toward the tab 28. As seen in FIG. 22, the top of the separation
surface 120 extends above the upper surface 74 of the wedge base
70, and may extend above the upper surface of the feeder belt 16.
As the separation surface 120 contacts the tab 28 during the
longitudinal travel of the active wedge 71, it applies a force to
the tab 28. As a result of the rotation of the staple 18 at its
point of connection to the feeder belt 16, that connection may have
experienced work hardening and become more brittle. As the
separation surface 120 of the wedge plate 112 contacts and applies
force to the tab 28, the that force applied by the separation
surface 120 breaks or shears the staple 18 from the feeder belt 16
at the tab 28. Where the staple 18 and/or tab 28 include a weakened
area at or near their intersection, the staple 18 may shear, break
or otherwise separate from the feeder belt 16 at that weakened
area. The separation surface 120 may be shaped to also actively
push, urge or otherwise eject the staple 18 completely out of the
staple holder 30. Alternately, the staple 18 is passively ejected
from the staple holder 30, meaning that the staple 18 is not
affirmatively urged out of the staple holder 30; rather, it is
simply released from the staple holder 30 and allowed to exit
therefrom. At this point, the deformed and ejected staple 18 is in
position in the blood vessel 148. The frangibility of the staples
18 allows the staples 18 to be held securely and reliably by the
feeder belt 16, and thus by the staple holder 30, while providing
for reliable separation and deployment.
[0096] After the staple 18 has been separated from the feeder belt
16, the active wedge 71 continues its motion in the distal
direction. As it does so, the active wedge 71 moves distal to the
peak 208 of the arm 204 it had previously deflected laterally. Such
motion of the active wedge 71 allows the arm 204 to return to its
neutral position, directly underneath a corresponding aperture 64
in the staple holder 30. Advantageously, the arm 204 is a leaf
spring, or acts as a leaf spring, that is biased toward the neutral
position. When in the neutral position, at least a portion of the
arm 204 is located directly underneath a corresponding aperture 64
in the staple holder 30. In this position, the arm 204 blocks the
deformed and separated staples 18 from falling back into the cavity
212 through the aperture 64. Instead, where a staple or staples 18
are deployed into air rather than into tissue, those closed,
separated staples 18 simply remain harmlessly in the body rather
than reentering the cavity 212 in the staple holder 30. Optionally,
where the wedge moves in the opposite direction, distal to
proximal, the staple trap 200 may be simply reversed in the staple
holder 30, and the operation of the tool is substantially as
described above, with the directions reversed. Such a wedge is
described in U.S. patent application Ser. No. 12/436,101 filed on
May 5, 2009, which is herein incorporated by reference in its
entirety. Although the staple trap 200 has been described here in
conjunction with an active wedge 71, a conventional single-piece
wedge could be utilized with the staple trap 200 instead, if
desired.
[0097] As the active wedge 71 continues its motion in the distal
direction, it encounters another staple 18, and deforms that staple
18 and separates that staple 18 from the feeder belt 16 in
substantially the same manner as described above. The wedge grate
110 may be long enough that, as the wedge grate 110 has deformed
one staple 18 a substantial amount but that staple 18 has not yet
separated from the feeder belt 16, the wedge grate 110 engages and
begins to deform the next most distal staple 18. Alternately, the
wedge grate 110 is short enough that it completely deforms one
staple 18, which is then ejected, before the wedge grate 110
engages and begins to deform the next most proximal staple 18. As
the active wedge 71 moves distally, the knife 124 also slides
distally along the knife slot 64, such that the sharp edge 126 of
the knife 124 cuts the tissue held between the anvil 32 and staple
holder 30. The knife 124 cuts tissue as the staples 18 are being
deformed and ejected. Optionally, where the I-beam head 128 is
fixed to the knife 124, that I-beam head 128 slides along a
corresponding channel in the anvil 32, such that clamping is
reinforced at or near the location of stapling as the active wedge
72 slides distally.
[0098] Referring to FIG. 23, the active wedge 71 may continue to
move distally until the cross pin 114 of each wedge grate 110
encounters the distal wall 144 of the corresponding channel 48.
Contact between each cross pin 114 and the corresponding distal
wall 144 prevents further distal motion of the cross pin 114, and
thus prevents further distal motion of the active wedge 71. Because
the pins 122 of the wedge plates 112 are already in the
corresponding detents 88 in the channels 82 in the wedge base 70,
the wedge grate 110 cannot move further proximally relative to the
wedge base 70 as a result of contact between the wedge grate 110
and the distal wall 144. This position of the active wedge 71 may
be referred to as the second, final position, and the wedge grate
110 is still in the second configuration.
[0099] The endocutter 2 may then be reset for another firing. To do
so, the actuation band 100 is retracted proximally such as by
actuating one or more controls on the handle 8. As the band 100
moves proximally, it exerts a force in the proximal direction on
the active wedge 71 and the wedge grate 110. When each cross pin
114 reaches the distal wall 144, the cross pin 114 may have already
moved distally to the distal wedge catch 134, referring also to
FIG. 24. The distal wedge catch 134 may include a portion proximal
to its peak 136 that slopes gently upward in the distal direction,
so that each cross pin 114 can push down the distal wedge catch 134
and slide over the peak 136 as it moves distally; after the cross
pin 114 has moved distally to the peak 136, the peak 136 springs
back upward. Thus, in the final position of the active wedge 71,
each cross pin 114 may be held between the distal wall 144 and a
peak 136 of the distal wedge catch 134. As the active wedge 71 is
urged proximally, each cross pin 114 of a wedge grate 110 is urged
proximally as well. However, each peak 136 of the distal wedge
catch 134 resists the proximal motion of the corresponding cross
pin 114, because each peak 136 is proximal to and in the path of
the cross pin 114, which in turn is constrained to move
substantially longitudinally and not vertically, as set forth
above. Consequently, each cross pin 114 does not ride up over the
corresponding peak 136 but rather is pulled longitudinally against
the distal wedge catch 134, which acts against the distal force
applied to the active wedge 71. As a result, each cross pin 114 is
held in place while the wedge base 70 moves proximally. This
relative motion between the cross pin 114 and the wedge base 70
urges each pin 122 extending from a corresponding wedge plate 112
distally out of the detent 88 in the corresponding channel in the
wedge base 70, referring also to FIG. 13. Each pin then slides down
the central segment 86 of the corresponding channel 82, until that
pin 122 is caught by and stops in the distal end 84 of the
corresponding channel 82. As a result of this motion of the pins
122, the wedge plates 112 and thus the wedge grate 110 as a whole
moves downward relative to the wedge base 70 to the first
configuration, as seen in FIG. 25. In the first, wedge-down
configuration, each wedge grate 110 is below the upper surface 74
of the wedge base 70, such that the wedge grate 110 does not
contact or otherwise engage the feeder belt 16 during motion of the
wedge base 70 proximally.
[0100] Optionally, where the wedge base 70 includes one or more
return arms 94, the return arms 94 may act to advance each feeder
belt 16. The tooth 96 may be biased against the lower portion of
the feeder belt 16. During advancement of the active wedge 71, the
tooth 96 sequentially engages apertures 51 in the corresponding
feeder belt 16, but due to the angled distal surface 99 of the
tooth 96, the tooth 96 slides out of each aperture 51 as the angled
distal surface 99 slides against the distal edge of each aperture
51, causing the cantilevered return arm 94 to flex upward. In this
way, the return arms 94 do not cause motion of the feeder belts 16
during deployment of staples 18. However, as the wedge base 70
moves distally, the tooth 96 of each return arm 94 slides into an
aperture 51 in the feeder belt 16 if those teeth 96 are not already
located in apertures 51. As the wedge base 70 moves distally, the
substantially vertical planar face 98 at the proximal end of each
tooth 96 encounters the proximal end of the corresponding aperture
51. Because the face 98 is substantially vertical, and not angled
to allow the tooth 96 to slip out, the face 98 engages the aperture
51, pushing the feeder belt 16 via the proximal edge of the
corresponding aperture 51. Each feeder belt 16 is routed around a
reversal wheel 42, along a path that starts generally straight and
in the distal direction, then is curved downward along the surface
of the corresponding reversal wheel 42, and then is generally
straight and in the proximal direction, such that the reversal
wheel 42 changes the direction of motion of the corresponding
feeder belt 16 from generally distal to generally proximal. The
portion of the feeder belt 16 located under and proximal to the
reversal wheel 42 may be retracted proximally, thereby pulling the
portion of the feeder belt 16 located above and proximal to the
reversal wheel 42 in the distal direction and advancing fresh
staples 18 into the housing 60. As the bottom portion of the feeder
belt 16 is moved proximally by the return arm 94, the upper portion
of the feeder belt 16 moves distally; this reversal of motion is
caused by the wrapping of the feeder belts 16 about substantially
half a circumference of the reversal wheels 42, as seen in FIGS.
10-11. Thus, as the wedge base 70 slides proximally back to its
initial position, the return arms 94 cause the feeder belt 16 to
advance a fresh set of unfired staples 18 into place within the
staple holder 30. The motion of the feeder belt 16 that advances
fresh staples 18 into position for firing may be referred to as
"advancing" the feeder belt 16, regardless of the fact that part of
the feeder belt 16 may be moved in a direction other than distally
during that advancing.
[0101] As the active wedge 71 is urged proximally by proximal
motion of the actuation band 100, each cross pin 114 of a wedge
grate 110 is urged distally as well. However, each peak 136 of the
distal wedge catch 134 resists the proximal motion of the
corresponding cross pin 114, because each peak 136 is proximal to
and in the path of the cross pin 114, which in turn is constrained
to move substantially longitudinally and not vertically.
Consequently, each cross pin 114 does not immediately ride up over
the corresponding peak 134, but rather is pulled longitudinally
against the distal wedge catch 134, which acts against the proximal
force applied to the active wedge 71. As a result, each cross pin
114 is held in place while the wedge base 70 withdraws proximally.
This relative motion between the cross pin 114 and the wedge base
70 urges each pin 122 extending from a corresponding wedge plate
112 out of the detent 88 at the proximal end of the corresponding
channel 82 in the wedge base 70, referring also to FIG. 13. Each
pin 122 then slides down the central segment 86 of the channel 82,
until that pin 122 is caught by and stops at the distal end 84 of
the channel 82. As a result of this motion of the pins 122, the
wedge plate 112 and thus the wedge grate 110 as a whole moves
downward relative to the wedge base 70 to the first, wedge-down
configuration.
[0102] As set forth above, in the first, wedge-down configuration,
each wedge plate 112 is positioned substantially below the upper
surface 74 of the wedge base 70. The wedge base 70 is still
substantially positioned at the final position, and each cross pin
114 is still located between the corresponding peak 136 of the
distal wedge catch 134 and the distal wall 144 of the corresponding
channel 48. The actuation band 100 continues to apply a force in
the proximal direction to the active wedge 71. Because the wedge
grate 110 can no longer move relative to the wedge base 70, that
proximal force applied to the active wedge 71 causes each crossbar
114 to push the distal wedge catch 134 downward. This may be
facilitated by a distally-sloped downward bend or angle in the
distal wedge catch 134 distal to each peak. That is, the force
applied to the distal wedge catch 134 by the active wedge 71 grows
large enough to push the distal wedge catch 134 out of the path of
motion of the wedge grate 110.
[0103] The active wedge 71 is then moved proximally until each
cross pin 114 of the active wedge 71 reaches the proximal wall 140
of each channel 48 in the bottom inner surface 49 of the staple
holder 30. Before it does so, each cross pin 114 may slide past the
proximal wedge catch 130. The proximal wedge catch 130 may include
a portion distal to its peak 136 that slopes gently upward in the
proximal direction, so that each cross pin 114 can push down the
proximal wedge catch 130 and slide over the peak 132 as it moves
proximally; after the cross pin 114 has moved proximal to the peak
132, the peak 132 springs back upward.
[0104] Next, the end effector 4 may be actuated again at the option
of the user, substantially as described above. In this way, the end
effector 4 may be actuated multiple times without removing the end
effector 4 through the trocar port 10 or other incision, structure
or mechanism that allows access to the interior of the body of the
patient. Keeping the end effector 4 within the body of the patient
without withdrawing that end effector 4 through the trocar port 10
or other incision, structure or mechanism that allows access to the
interior of the body of the patient may be referred to as
maintaining the end effector within the body of the patient. The
endocutter 2 may be actuated multiple times within the patient,
without being removed from the patient, until the staples 18 in the
endocutter 2 are exhausted. An indicator may be provided in the
handle 8 or at another location in the endocutter 2 that shows how
many unfired staples 18 remain in the endocutter 2.
[0105] Actuation of the endocutter 2 above has been generally
described in terms of deployment and ejection of a single row 26 of
staples 18 for clarity, where that deployment and ejection may be
performed in substantially the same manner along each row 26 of
staples 18. Operation of the endocutter 2 may be substantially as
described above with regard to any number of rows 26 of staples 18
on a feeder belt 16, or any number of feeder belts 16. Further,
operation of the endocutter 2 may be performed during testing, in
which case the possessing of the endocutter 2 may be performed by a
human or by a machine. During testing, the tissue utilized may be
artificial or simulated, and actuation of the endocutter 2 is
performed as if that were actual tissue.
[0106] While the invention has been described in detail, it will be
apparent to one skilled in the art that various changes and
modifications can be made and equivalents employed, without
departing from the present invention. It is to be understood that
the invention is not limited to the details of construction, the
arrangements of components, and/or the method set forth in the
above description or illustrated in the drawings. Statements in the
abstract of this document, and any summary statements in this
document, are merely exemplary; they are not, and cannot be
interpreted as, limiting the scope of the claims. Further, the
figures are merely exemplary and not limiting. Topical headings and
subheadings are for the convenience of the reader only. They should
not and cannot be construed to have any substantive significance,
meaning or interpretation, and should not and cannot be deemed to
indicate that all of the information relating to any particular
topic is to be found under or limited to any particular heading or
subheading. Therefore, the invention is not to be restricted or
limited except in accordance with the following claims and their
legal equivalents.
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