U.S. patent application number 13/778817 was filed with the patent office on 2013-07-11 for multiple-use surgical stapler.
This patent application is currently assigned to Cardica, Inc.. The applicant listed for this patent is Cardica, Inc.. Invention is credited to Bryan D. Knodel, Jinhoon Park, Bennie Thompson.
Application Number | 20130175316 13/778817 |
Document ID | / |
Family ID | 47892264 |
Filed Date | 2013-07-11 |
United States Patent
Application |
20130175316 |
Kind Code |
A1 |
Thompson; Bennie ; et
al. |
July 11, 2013 |
MULTIPLE-USE SURGICAL STAPLER
Abstract
A surgical apparatus may include an end effector comprising a
staple holder including a housing therein, and an anvil connected
to the staple holder, where the end effector is movable between an
open configuration and a clamped configuration; a feeder belt
having two lateral edges, at least part of which is held within the
housing; a plurality of staples, where each staple has a first end
frangibly connected to the feeder belt and a second, free end;
where at least one staple is oriented relative to the corresponding
feeder belt in a direction angled relative to the transverse
direction; and wherein the staples form at least one row, each row
including at least two staples; and an overtube movable relative to
the staple holder and anvil, where motion of the overtube relative
to the staple holder and anvil both clamps the staple holder and
anvil together and clamps the feeder belt in place relative to the
housing. Such an end effector may be utilized by inserting it into
the body of a patient through an opening; clamping the end
effector; closing a plurality of staples into a closed
configuration; and separating each closed staples from the
corresponding feeder belt.
Inventors: |
Thompson; Bennie;
(Cincinnati, OH) ; Park; Jinhoon; (Palo Alto,
CA) ; Knodel; Bryan D.; (Flagstaff, AZ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Cardica, Inc.; |
Redwood City |
CA |
US |
|
|
Assignee: |
Cardica, Inc.
Redwood City
CA
|
Family ID: |
47892264 |
Appl. No.: |
13/778817 |
Filed: |
February 27, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12263171 |
Oct 31, 2008 |
8403956 |
|
|
13778817 |
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|
11956988 |
Dec 14, 2007 |
7954683 |
|
|
12263171 |
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|
11851379 |
Sep 6, 2007 |
7988026 |
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11956988 |
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Current U.S.
Class: |
227/175.1 |
Current CPC
Class: |
A61B 17/068 20130101;
A61B 17/1222 20130101; A61B 17/064 20130101; A61B 2017/07278
20130101; A61B 2090/037 20160201; A61B 17/07207 20130101; A61B
2017/00544 20130101; A61B 17/072 20130101; A61B 17/0293 20130101;
A61B 2017/00398 20130101; A61B 2017/07271 20130101 |
Class at
Publication: |
227/175.1 |
International
Class: |
A61B 17/068 20060101
A61B017/068 |
Claims
1. A surgical apparatus for treating tissue within a body of a
patient, comprising: an end effector with a first plurality of
staples arranged in a firing position, said first plurality of
staples frangibly connected to a feeder belt; a wedge element to
deploy said first plurality of staples to a first portion of tissue
of the patient by a first actuation of the surgical apparatus; and
a drive mechanism to reset the wedge and move a pawl to advance the
feeder belt along with a second plurality of staples frangibly
connected to said feeder belt into the firing position for a next
deployment of staples to a second portion of tissue of the patient
by a second actuation of the surgical apparatus.
2. A surgical apparatus, comprising: an end effector with a first
plurality of staples arranged in a firing position, said first
plurality of staples frangibly connected to a feeder belt; a wedge
element to deploy said first plurality of staples by a first
actuation of the surgical apparatus; and a drive mechanism to reset
the wedge and move a pawl to advance the feeder belt along with a
second plurality of staples frangibly connected to said feeder belt
into the firing position for a next deployment in a second
actuation of the surgical apparatus.
3. The surgical apparatus of claim 2, wherein the pawl includes an
upward-extending stop to engage and advance said feeder belt.
4. The surgical apparatus of claim 2, wherein the pawl includes a
downward-extending ramp to allow movement of the pawl without
causing the feeder belt to move along with the pawl.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation application of U.S.
patent application Ser. No. 12/263,171, Attorney Docket No. 245,
filed Oct. 31, 2008, which is a Continuation-in-Part of U.S. patent
application Ser. No. 11/956,988, Attorney Docket No. 230, filed
Dec. 14, 2007, which in turn is a Continuation-in-Part of U.S.
patent application Ser. No. 11/851,379, Attorney Docket No. 219,
filed Sep. 6, 2007, all of which are hereby incorporated by
reference in their entireties.
FIELD OF THE INVENTION
[0002] The invention generally relates to surgical staples and
stapling.
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 order to deploy more staples, the
endocutter must be moved away from the surgical site and removed
from the patient, after which the old cartridge is exchanged for a
new cartridge. The endocutter is then reinserted into the patient.
However, it can be difficult and/or time-consuming to located the
surgical site after reinsertion. Further, the process of removing
the endocutter from the patient after each use, replacing the
cartridge, and then finding the surgical site again is tedious,
inconvenient and time-consuming, particularly where a surgical
procedure requires multiple uses of the endocutter. That
inconvenience may discourage surgeons from using the endocutter for
procedures in which use of an endocutter may benefit the patient.
Similar inconveniences may accompany the use of surgical staplers
other than endocutters.
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 cross-section view of trocar ports positioned in
a patient.
[0008] FIG. 4 is a perspective view of an exemplary feeder belt
with three rows of staples frangibly connected thereto.
[0009] FIG. 5 is a side view of the feeder belt of FIG. 4.
[0010] FIG. 6 is a top view of the feeder belt of FIG. 4.
[0011] FIG. 7 is a side view of an exemplary end effector of an
endocutter that utilizes the feeder belt of FIGS. 4-6.
[0012] FIG. 7A is a bottom view of a lower surface of an exemplary
anvil of an endocutter.
[0013] FIG. 7B is a side cutaway view of a staple forming pocket
defined in the lower surface of the anvil of FIG. 7A.
[0014] FIG. 8 is a perspective view of an exemplary feeder belt
guide.
[0015] FIG. 9 is a side cross-section view of the feeder belt guide
of FIG. 8, not including a feeder belt.
[0016] FIG. 10 is a side cross-section view of the feeder belt
guide of FIG. 8, including a feeder belt.
[0017] FIG. 11 is a perspective view of an exemplary housing of a
staple holder of the exemplary end effector of FIG. 7.
[0018] FIG. 12 is a perspective cutaway view of the exemplary end
effector of FIG. 7.
[0019] FIG. 13 is a perspective view of an exemplary wedge
assembly.
[0020] FIG. 14 is a perspective view of an exemplary block of the
exemplary end effector of FIG. 7.
[0021] FIG. 15 is a perspective view of an exemplary cutter.
[0022] FIG. 16 is a side cutaway view of the exemplary end effector
of FIG. 7.
[0023] FIG. 17 is a perspective view of a retainer of the exemplary
end effector of FIG. 7.
[0024] FIG. 17A is a perspective view of the underside of the
retainer of FIG. 17.
[0025] FIG. 18 is a perspective view of an exemplary feeder belt
with two rows of staples frangibly connected thereto.
[0026] FIG. 19 is a side view of the feeder belt of FIG. 18.
[0027] FIG. 20 is a top view of the feeder belt of FIG. 18.
[0028] FIG. 21 is a side cross-section view of an exemplary end
effector of an endocutter that utilizes the feeder belt of FIGS.
18-20.
[0029] FIG. 22 is a perspective view of an exemplary housing of a
staple holder of the exemplary end effector of FIG. 21.
[0030] FIG. 23 is a perspective view of a block of the exemplary
end effector of FIG. 21.
[0031] FIG. 23A illustrates another example of a wedge
assembly.
[0032] FIG. 24 is a detail cross-section view of the exemplary end
effector of FIG. 21 in the vicinity of the block.
[0033] FIG. 25 is a perspective view of another exemplary feeder
belt with two rows of staples frangibly connected thereto.
[0034] FIG. 26 is a side view of the feeder belt of FIG. 25.
[0035] FIG. 27 is a top view of the feeder belt of FIG. 25.
[0036] FIG. 28 is a perspective view of the distal end of another
exemplary wedge assembly.
[0037] FIG. 28A is a side view of the distal end of another
exemplary wedge assembly.
[0038] FIG. 29 is a perspective view of a blood vessel after
transection by an endocutter.
[0039] FIG. 30 is a perspective view of sliding clamps, each in a
first position relative to a corresponding feeder belt.
[0040] FIG. 31 is a side view of the sliding clamps of FIG. 30,
each in a first position relative to a corresponding feeder
belt.
[0041] FIG. 32 is a perspective view of the sliding clamps of FIG.
30, each in a second, clamping position relative to a corresponding
feeder belt.
[0042] FIG. 33 is a side view of the sliding clamps of FIG. 30,
each in a second, clamping position relative to a corresponding
feeder belt.
[0043] FIG. 34 is an exploded perspective view of the distal end of
an exemplary endocutter.
[0044] FIG. 35 is a perspective view of another exemplary feeder
belt with two rows of staples frangibly connected thereto.
[0045] FIG. 36 is a perspective view of an exemplary cutter
including a cam surface defined thereon.
[0046] FIG. 37 is an exploded view of an exemplary handle of the
endocutter.
[0047] FIG. 38 is a perspective cutaway view of the exemplary
handle of FIG. 37.
[0048] FIG. 39 is an exploded perspective view of the proximal end
of an exemplary endocutter, distal to the handle thereof.
[0049] FIG. 40 is an exploded perspective view of a portion of the
endocutter located between the views of FIGS. 34-39.
[0050] FIG. 41 is a perspective view of the proximal end of an
exemplary driver.
[0051] FIG. 42 is a perspective view of a center portion of the
exemplary driver of FIG. 41.
[0052] FIG. 43 is a perspective view of the distal end of an
exemplary driver.
[0053] FIG. 44 is a perspective cutaway view of an exemplary staple
holder and an exemplary clamp therein.
[0054] FIG. 45 is a detail perspective view of a connection between
the proximal end of the exemplary clamp of FIG. 44 and an exemplary
overtube.
[0055] FIG. 46 is a perspective view of an exemplary top plate.
[0056] FIG. 47 is a side view of the exemplary top plate, an
exemplary bottom plate, a central portion of the exemplary driver
of FIG. 42, and a gear.
[0057] The use of the same reference symbols in different figures
indicates similar or identical items.
DETAILED DESCRIPTION
[0058] Endocutter--Three Staple Rows
[0059] 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 FIGS. 2-3,
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 14. 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.
[0060] The trocar port 10 is 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 14, 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.
[0061] 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.
[0062] 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.
[0063] Referring to FIGS. 4-6, a portion of a feeder belt 16 is
positioned within the end effector 4. The feeder belt 16 and
associated hardware may be as set forth in U.S. patent application
Ser. No. 11/956,988, filed Dec. 14, 2007, and U.S. patent
application Ser. No. 11/851,379, filed Sep. 6, 2007, both of which
are hereby incorporated by reference in their entirety. 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, at least part of the feeder belt 16 may be rigid or at
least partially rigid, such that the feeder belt 16 may be advanced
or retracted substantially linearly without redirection about a
structure, or may be otherwise manipulated. 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.
Referring particularly to FIG. 5, 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. 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. The base of the V-shape of the staple 18
may be curved, pointed or otherwise configured. 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 attached 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. The staples
18 may be connected to the feeder belt 16 in any suitable
orientation. As one example, one or more of the staples 18 are
oriented generally parallel to the longitudinal centerline of the
feeder belt 16. That is, one or more of the staples 18 each may lie
in a plane that is generally parallel to the longitudinal
centerline of the feeder belt 16, as shown in FIG. 6. As another
example, one or more of the staples 18 each may be oriented in a
direction angled relative to the longitudinal centerline of the
feeder belt 16. As another example, the staples 18 each may be
oriented in a direction angled relative to the transverse
direction, which is the direction perpendicular to the longitudinal
centerline of the feeder belt 16.
[0064] 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.
[0065] A frangible connection between the feeder belt 16 and each
corresponding staple 18 may be made in any suitable manner. As one
example, referring particularly to FIG. 6, 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.
[0066] As shown in FIGS. 4-6, 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. As best seen in
FIG. 6, three rows 26 of staples 18 may be attached to the feeder
belt 16--one row 26 along each side of the feeder belt 16, and one
row 26 along the center of the feeder belt 16. 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.
[0067] 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. As may be best seen in FIG. 6, the center row 26 of
staples 18 may be staggered relative to the rows 26 of staples 18
along the lateral edges of the feeder belt 16. Alternately, two or
more rows 26 of staples 18 may be staggered in a different manner.
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.
[0068] 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.
[0069] Referring also to FIG. 7, the end effector 4 may include a
staple holder 30 and an anvil 32. The anvil 32 may be movable
relative to the staple holder 30 to compress tissue therebetween.
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. As one
example, at least one pin 34 may extend generally laterally from
the anvil 32 at a location at or near the proximal end of the anvil
32. Each pin 34 may be received by a trough 36, aperture, or other
feature of the staple holder 30 that allows that pin 34 to rotate
therein and thereby allows the anvil 32 to pivot. Referring also to
FIG. 16, 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.
Alternately, the trough 36 may be located in the shaft 6 of the
endocutter, such that the anvil 32 is pivotally attached to the
shaft 6 and movable relative to the staple holder 30. 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.
[0070] Referring also to FIG. 7A, the inner surface 202 of the
anvil 32, which is the surface of the anvil 32 oriented generally
toward the staple holder 30, may include staple forming pockets 204
defined therein. As described in greater detail below, referring
also to FIGS. 18-20, 30-33 and 35, as the staples 18 are deployed,
the free end 22 of each staple 18 may be forced into a
corresponding staple forming pocket 204, whereby contact between
the free end 22 and proximal leg 196 of that staple 18 causes that
staple 18 to close. Referring also to FIG. 7B, each staple forming
pocket 204 may be shaped in any suitable manner. As one example, at
least one staple forming pocket 204 may be asymmetrical, with at
least two sections having different radii of curvature. Experiment
has shown that closure of a staple 18 is improved by the use of a
staple forming pocket 204 having a first radius of curvature at a
proximal section 206 thereof, and a second, shorter radius of
curvature at a distal section 208 thereof. The inner surface 202 of
the anvil 32 may include a generally longitudinal slot 210 defined
therein, through which at least part of the knife 90 may slide, as
described in greater detail below. The slot 210 may have a
substantially constant depth along at least part of its length. A
cam engagement feature 212 may be defined in the slot 210, with a
depth less than an adjacent segment of the slot 210. The cam
engagement feature 212, if present, may be sized and shaped to
engage the cam surface 107 of the knife 90, as described in greater
detail below.
[0071] The staple holder 30 may include any suitable components.
Referring also to FIGS. 8-10, the staple holder 30 may include a
feeder belt guide 40. The feeder belt guide 40 may be shaped in any
suitable manner. The staple holder 30 may be configured such that
the distal end of the feeder belt guide 40 is the distal end of the
end effector 4. If so, the distal end 42 of the feeder belt guide
40 may be generally blunt. The upper surface 44 of the distal end
42 of the feeder belt guide 40 may be angled generally upward,
moving proximally along the feeder belt guide 40. Alternately, the
upper surface 44 of the distal end 42 of the feeder belt guide 40
may be shaped in any other suitable manner. One or more apertures
46 may be defined in the upper surface 44 of the distal end 42 of
the feeder belt guide 40. Alternately, one or more of the apertures
46 may be omitted, such that the upper surface 44 of the distal end
42 of the feeder belt guide 40 is instead continuous. The distal
end 42 of the feeder belt guide 40 may include a space 48 defined
therein. At least one nose 50 may protrude distally into that space
48. Each nose 50 may be curved, and may have a convex shape. As one
example, each nose 50 may have an arcuate shape, where that arc is
a section of a circle. Alternately, at least one nose 50 may be
shaped differently. As one example, at least one nose 50 may be
shaped as two or more straight lines that collectively approximate
a curve, roughly or smoothly.
[0072] Referring also to FIG. 12, the end effector 4 may include
two 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 nose
50, where the noses 50 are laterally spaced from one another and
positioned on opposite sides of a knife, which is described below.
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 nose 50, and then is
generally straight and in the proximal direction. That is, the nose
50 changes the direction of motion of the corresponding feeder belt
16 from generally distal to generally proximal. Each nose 50 may be
substantially as wide as the corresponding feeder belt 16 that
moves along its surface. Alternately, at least one nose 50 may be
narrower than, or wider than, the corresponding feeder belt 16.
Alternately, the nose 50 may be omitted, where the feeder belt 16
is movable generally linearly.
[0073] At least one nose 50 may be bifurcated by a slot 52 defined
therein. The slot 52 may be oriented generally longitudinally.
However, the slot 52 may be defined in any other suitable
orientation. Each feeder belt 16 is positioned in contact with at
least part of a corresponding nose 50, with staples 18 in each
lateralmost row 26 of the feeder belt 16 positioned laterally on
either side of the nose 50. Where the feeder belt 16 includes a row
26 of staples 18 in the middle of that feeder belt, such as shown
in FIG. 6, the slot 52 in the nose 50 may be laterally oriented in
substantially the same position as the middle row 26 of staples 18.
In this way, the slot 52 provides space for that middle row 26 of
staples 18 to slide along. Alternately, at least one nose 50 may be
divided into segments by two or more slots 52, depending on the
number of rows 26 of staples 18 attached to the corresponding
feeder belt 16. Alternately, the slot or slots 52 need not extend
to the distal end of the nose 50, because the staples 18 have been
deployed from the corresponding segment of the feeder belt 16 by
the time that segment of the feeder belt 16 reaches the nose 50, as
described in greater detail below. Alternately, at least one slot
52 may be omitted. At least one nose 50 may extend in the proximal
direction any suitable length. Similarly, the remainder of the
feeder belt guide 40 may extend in the proximal direction any
suitable length. The portion of the feeder belt guide 40 proximal
to the distal end 42 may be referred to as the insert 43. A knife
slot 54 may extend along the length of the feeder belt guide 40,
and may extend through the upper surface 44 of the distal end 42 of
the feeder belt guide 40.
[0074] Referring also to FIG. 34, one or more pulleys 180 may be
utilized in place of the nose 50. The pulleys 180 may be generally
circular in shape, or may be shaped in any other suitable manner.
Each pulley 180 may have a width substantially equal to or less
than a corresponding feeder belt 16. Optionally, at least one
pulley 180 may be wider than a corresponding feeder belt 16,
because staples 18 have been sheared or otherwise separated from
the portion of the feeder belt 16 that contacts the pulley 16, as
set forth in greater detail below. Consequently, a single pulley
180 may be used if desired, where that pulley 180 is at least as
wide as the distance between the lateralmost edges of the feeder
belts 16, taken collectively. Each pulley 180 rotates about an axle
182. Referring also to FIG. 11, at least one aperture 184,
depression, or other feature may be defined in the housing 60 near
the distal end thereof, such that the axle 182 is received therein.
As one example, two apertures 184 are located in proximity to the
distal end of the housing 60, and the axle 182 extends into both
apertures 184. The apertures 184 are oriented relative to the
housing 60 such that the axle 182 is in turn oriented generally
perpendicular to the longitudinal centerline of the housing 60. The
axle 182 may be fixed to the housing 60 at one or more apertures
184, or may be free to rotate relative to the apertures 184. As
another example, at least one pulley 180 is fixed to the axle 182,
and the axle is allowed to rotate freely relative to the apertures
184. Each pulley 180 advantageously may be an idler pulley that
acts to tension the corresponding feeder belt 16, and that rotates
freely as the corresponding feeder belt 16 is advanced. The use of
one or more pulleys 180 advantageously reduces friction during
advancement of the feeder belt 16, compared with the use of a fixed
nose 50.
[0075] Referring to FIG. 11, a housing 60 is shown. The housing 60
may be fabricated from a single piece of sheet metal. Alternately,
the housing 60 may be fabricated in any other suitable manner
and/or from any other material. The housing 60 may include a
generally flat base 62, with two outer walls 64 extending upward
generally perpendicularly from the base 62. The base 62 and outer
walls 64 may be generally rectangular. The outer walls 64 may be
generally parallel to one another. Alternately, the base 62 and
outer walls 64 may be shaped differently, and/or oriented
differently relative to one another. A top plate 66 may extend
generally laterally from the upper edge of each outer wall 64, such
that the two top plates 66 generally lie in the same plane. Each
top plate 66 may be generally rectangular. A number of apertures 67
may be defined in each top plate 66, where the apertures 67 allow
for deployment of staples 18 therethrough. The two top plates 66
may be spaced apart from one another along their length. An inner
wall 68 extends generally downward from the inner edge of each top
plate 66, and may be generally perpendicular to the corresponding
top plate 66. Each inner wall 68 may be generally rectangular, and
the inner walls 68 may be spaced apart from and generally parallel
to one another. However, at least one inner wall 68 may be shaped
and/or oriented differently. The inner walls 68 may be spaced apart
far enough to allow a knife to pass between them, as described in
greater detail below. The lower edge of at least one inner wall 68
may contact the base 62, or may be spaced apart from the base 62. A
receiving space 70 is a volume in the housing created by the base
62, outer wall 64, top plate 66 and inner wall 68. Two receiving
spaces 70 may be defined in the housing 60.
[0076] At least part of the housing 60 may omit the top plates 66
and/or inner walls 68, such that at least part of the housing 60 is
generally U-shaped. The feeder belt guide 40 may be attached to the
housing 60. This attachment may be accomplished in any suitable
manner. As one example, the insert 43 portion of the feeder belt
guide 40 may be inserted into one or more receiving spaces 70, then
fixed thereto in any suitable manner. As another example, the
feeder belt guide 40 may not include an insert 43, and the feeder
belt guide is attached to the distal end of the housing 60 in any
suitable manner. As another example, the feeder belt guide 40 may
be fabricated integrally with the housing 60. Alternately, the
feeder belt guide 40 is not attached to or fixed to the housing
60.
[0077] Referring also to FIG. 13, one or more wedge assemblies 72
extend into the staple holder 30 of the end effector 4. Each wedge
assembly 72 may include a wedge 74 at the distal end of a arm 76.
Alternately, the wedge 74 may be positioned at a different location
on the arm 76. The wedge 74 may be shaped in any suitable manner.
As one example, the upper surface of the wedge 74 may include a
first surface 79 that may be angled or curved upward, moving in the
distal direction. The wedge 74 may also include a second surface 80
distal to the first surface 79, where the second surface may be
angled or curved downward, moving in the distal direction. The
intersection between the first surface 79 and the second surface 80
may be a curved or smooth peak 82. Alternately, the peak 82 may
form an unsmoothed angle between the first surface 79 and the
second surface 80. The lower surface of the wedge 74 may be
substantially linear. Alternately, the lower surface of the wedge
74 may be curved, angled or otherwise shaped in any suitable
manner. A tab 78 may be connected to the proximal end of the arm
76. Alternately, the tab 78 may be positioned at a different
location on the arm 76. The tab 78 may be substantially
rectangular, or may be shaped in a different manner. The tab 78 may
extend in a downward direction from the arm 76, and the wedge 74
may extend in an upward direction from the arm 76. Alternately, the
wedge 74 and/or tab 78 are oriented differently relative to the arm
76. Advantageously, the wedge assembly 72 is fabricated as a
single, integral structure. However, the wedge assembly 72 may be
assembled from separate components, in any suitable manner.
Referring to FIG. 12, each wedge 74 may be initially positioned
distal to a row 26 of staples 18, and may be generally
longitudinally aligned with, and longitudinally movable relative
to, that corresponding row 26 of staples 18. The length of each
wedge 74 may be equal to or less than the longitudinal spacing
between staples 18 in a row 26, such that the wedge 74 deploys each
staple 18 before moving into contact with the subsequent staple 18
in the row 26. This configuration of wedge 74 is particularly
useful where the length of the staple line is adjustable, because
the deployment of one staple 18 is independent of the deployment of
any other staple 18. Alternately, the wedge 74 may be longer than
the longitudinal spacing between staples 18 in a row 26, such that
deployment of one staple 18 concludes while the
longitudinally-adjacent staple 18 is in the middle of deployment.
Such a configuration of wedge 74 may be useful where the length of
the staple line is fixed, and a blank space is provided on the
feeder belt 16 between groups of staples 18 along a row 26.
[0078] Referring also to FIG. 14, the tab 78 of each wedge assembly
72 may be inserted into a receiving slot 86 in a block 84. Each
receiving slot 86 may be defined partially into, or completely
through, the block 84. The receiving slot or slots 86 may be
defined in the upper surface 88 of the block 84, or in a different
surface of the block 84. The receiving slot or slots 86 may be
positioned at or near the distal end of the block 84, or at a
different location on the block 84. Referring also to FIG. 15, a
knife 90 may include a hook 92 at its proximal end. A pin 94 may
extend laterally across a knife receiving slot 96 defined in the
distal end of the block 84, and the hook 92 may engage that pin 94.
The pin 94 may be generally cylindrical, or may have any other
suitable shape for engaging the hook. Alternately, the knife
receiving slot 86 is defined in a different part of the block 84.
Alternately, the hook 92 of the knife 90 may be a tab similar to
the tab 78 of the wedge assembly 72, and the knife receiving slot
86 may thus be configured in the same way as the receiving slots 86
for the tabs 78 of the wedge assemblies 72. Alternately, the hook
92 may be shaped in any other suitable manner, such as a shape that
is not a hook, and the knife receiving slot 96 may be configured
accordingly. Alternately, the receiving slots 86, knife receiving
slot 86 and/or tabs 78 may be omitted, and the wedge assemblies 72
and/or knife 90 are connected to the block 84 in a different way,
such as by molding. Alternately, the wedge assemblies 72, knife 90
and block 84 may be fabricated as an integral unit. The block 84
may be generally shaped as a rectangular solid. Alternately, the
block 84 may be shaped in any other suitable manner. A protrusion
98 may extend generally upward from the upper surface 88 of the
block 84, at a location at or near the proximal end of the block
84. Alternately, the protrusion 98 may extend in a different
direction and/or may extend from a different location on the block
84. The protrusion 98 may be generally shaped as a rectangular
solid, but may be shaped in any other suitable manner. Alternately,
the block 84 may be omitted, and the wedge assembly 72 and knife 90
may be controlled and/or manipulated in any other suitable
manner.
[0079] At least part of the block 84 may be positioned in a space
such as the recess 120 (FIG. 17A) defined within the end effector 4
and/or the shaft 6, and the block 84 may be longitudinally slidable
along that space in order to control the motion of the wedge
assemblies 72 and the knife 90. Alternately, the block 84 may be
positioned differently relative to the end effector 4 and/or the
shaft 6. Optionally, one or more sliders 100 may extend downward
from the lower surface 102 of the block 84 to engage a
corresponding feature or features in the end effector 4 and/or
shaft 6 in order to facilitate sliding of the block 84.
Alternately, the sliders 100 may be omitted. Referring also to FIG.
16, a rod 104 may be connected to the protrusion 98 in any suitable
manner. As one example, the rod 104 may be molded into the
protrusion 98. The distal end of the rod 104 may be connected to
the protrusion 98, and the rod 104 may extend through the shaft 6
such that the proximal end of the rod 104 extends into the handle
8. The rod 104 may be generally rigid, and may extend generally
longitudinally into the shaft 6 and/or through the shaft 6 to the
handle 8. Alternately, the rod 104 may be flexible and/or threaded,
and the rod 104 may engage corresponding threads provided in the
protrusion 98 or other part of the block 84. In this way, rotation
of the rod 104 causes the block 84 to advance or retract
longitudinally.
[0080] Referring also to FIG. 15, the knife 90 may include a body
106 extending in the distal direction from the hook 92. Like the
arm 76 of a wedge assembly 72, the body 106 of the knife 90 may be
laterally thin, and longer than it is wide or high. Alternately,
the body 106, and/or at least one arm 76, may be shaped
differently. The body 106 may include a cam surface 107 extending
upward therefrom, at a location between the proximal and distal
ends of the body 106. The cam surface 107 may be shaped in any
suitable manner. As one example, the cam surface 107 may extend
gradually upward in the distal direction, then end at a vertical
surface substantially perpendicular to a portion of the body 106
proximal to the cam surface 107. Referring also to FIG. 7A, the cam
surface 107 may be shaped and sized to engage a corresponding
feature 200 defined on the surface of the anvil 32 in order to cam
the knife 90 away from the anvil 32 during at least part of the
actuation of the endocutter 2 and/or the advancement of unfired
staples 18 into firing position, as described in greater detail
below. A blade 108 may be located at the distal end of the body
106. Advantageously, the knife 90 may be fabricated as a single,
integral structure. However, the knife 90 may be assembled from a
separate hook 92, body 106 and/or blade 108. The blade 108 may be
configured in any suitable manner for cutting tissue. As one
example, the blade 108 includes a cutting edge 110 along its upper
edge, where that cutting edge 110 may be angled upward moving
proximally along the blade 108. Alternately, the cutting edge 110
may be oriented differently, or positioned differently on the blade
108. Referring also to FIG. 11, the knife 90 is movable along at
least part of the space between the inner walls 68 of the housing
60. Part of each feeder belt 16 is positioned in each receiving
space 70, laterally outward from the inner walls 68 of the housing
60. Thus, the knife 90 is movable longitudinally between two feeder
belts 16.
[0081] Optionally, the blade 108 and/or cutting edge 110 of the
knife 90 may be heated in order to cauterize tissue. Optionally, an
electric current may be passed through the blade 108 of the knife
90 such that the blade 108 electrically cauterizes tissue. The
blade 108 may be unipolar, or may be one pole of a bipolar system.
Optionally, the knife 90 may be omitted, and in its place a wire
may be used. The wire may be threaded distally into the staple
holder 30, upward from the staple holder 30 into the anvil 32, then
proximally out of the anvil 32. Proximal motion of the wire causes
the wire to move through tissue, cutting it. The wire may be an
electrode, such that electricity may be applied to it to facilitate
both cutting and electrocauterization of tissue. The wire may be
removed after each use and a new wire advanced, in order for the
end effector 4 to be able to clamp another tissue structure, and to
allow the wire to be replaced each time to maximize its cutting
and/or cauterizing ability.
[0082] Referring also to FIG. 16, a cross-sectional view of the end
effector 4 in an initial configuration is shown. The blade 108 of
the knife 90 may be positioned entirely within the staple holder 30
in the initial configuration, to ensure that the cutting edge 110
does not incise tissue as the end effector 4 is moved to the
surgical site. Further, the blade 108 may be positioned within the
distal end 42 of the feeder belt guide 40 in the initial
configuration. Alternately, the blade 108 may be positioned
differently. In the initial configuration, the staples 18 may be
positioned within the staple holder 30 in position for deployment,
each located under a corresponding aperture 67 in the top plate 66.
The block 84 is located in an initial position corresponding to the
initial position of the blade 108 and the wedge assemblies 72.
Advantageously, in the initial configuration, the wedge assemblies
72 and the knife 90 are each in their most-distal position.
However, at least one wedge assembly 72 and/or the knife 90 may be
positioned differently in the initial position.
[0083] Referring also to FIG. 17, a retainer 112 may be positioned
between the end effector 4 to the shaft 6. Optionally, the retainer
112 may provide a connection between the end effector 4 and the
shaft 6, such as by friction or interference fitting with both the
end effector 4 and the shaft 6, or by otherwise connecting both the
end effector 4 and the shaft 6 to the retainer 112. Alternately,
the retainer 112 may be positioned entirely within the end effector
4. The retainer 112 may be shaped in any suitable manner. The
retainer 112 may include an extension 114 protruding distally from
a first body segment 118, where the extension 114 includes a ramp
116 at the distal end thereof. The ramp 116 may be angled upward in
the proximal direction. The ramp 116 may be generally linear.
Alternately, the ramp 116 may be oriented differently, and may be
curved or otherwise shaped. The first body segment 118 may be
shaped and sized to be received in the proximal end of the housing
60, and at least part of the first body segment 118 may extend into
the proximal end of at least one receiving space 70 of the housing
60. The first body segment 118 may be fixed to the housing 60, such
as by pressure or interference fitting, by adhesive, by welding, or
by any other suitable mechanism or method. Alternately, the first
body segment 118 is not fixed to the housing 60. Alternately, the
retainer 112 is not fixed or connected to the housing 60.
Alternately, the retainer 112 may be omitted. Optionally, at least
part of the feeder belt guide 40 may be connected to the retainer
112 as well. As one example, the insert 43 of the feeder belt guide
40 may extend completely through a receiving space 70 in the
housing 60 and into contact with the retainer 112. If so, the
feeder belt guide 40 may be connected to the retainer 112 in any
suitable manner.
[0084] Referring also to FIG. 17A, the underside of the retainer
112 may include a recess 120 defined therein. The recess 120 may be
shaped and sized to allow the block 84 to slide therein. The recess
120 may include a slot 122 defined therethrough, where the slot 122
may receive the protrusion 98 and allow the protrusion 98 to slide
therein. The recess 120 and/or slot 122 may guide the motion of the
block 84 longitudinally and restrict motion of the block 84
proximal or distal to certain locations, and may also or instead
restrict lateral motion of the block 84. For example, the recess
120 may include a distal wall 124 that contacts the distal end of
the block 84 when the block 84 has advanced distally as far as
desired, and a proximal wall 126 that contacts the proximal end of
the block 84 when the block 84 has retracted proximally as far as
desired. Alternately, the recess 120 may be defined in a different
part of the retainer 112, or may be omitted.
[0085] Referring to FIG. 30, optionally sliding clamps 160 may be
provided, where each set of sliding clamps 160 may be associated
with a corresponding feeder belt 16. Each set of sliding clamps 160
may include an upper clamp 162 and a lower clamp 164, where at
least one of the clamps 162, 164 is slidable relative to the other.
The lower clamp 164 may have a slot 166 defined generally
longitudinally therein and oriented generally upward. The upper
clamp 162 may have a tongue 168 oriented generally downward, where
the tongue 168 is sized and configured to be received in the slot
166 in the lower clamp 164. The tongue 168 may be narrower than the
remainder of the upper clamp 162, or may be sized in any other
suitable manner. The wider area of the upper clamp 162 from which
the tongue 168 extends forms a ledge 169 at its lower surface. The
upper surface of the upper clamp 162 may be substantially as wide
as the feeder belt 16.
[0086] Referring also to FIG. 31, initially the distal end of the
upper clamp 162 may extend further in the distal direction than the
distal end of the lower clamp 164. Alternately, the distal end of
the lower clamp 164 initially may extend further in the distal
direction than the distal end of the upper clamp 162. Alternately,
initially the distal ends of each clamp 162, 164 may extend
substantially the same distance in the distal direction. The upper
surface of the lower clamp 164 may have a cam surface 170 defined
thereon. Similarly, the ledge 169 of the upper clamp 162 may be
shaped to define a cam surface 172 thereon. The two cam surfaces
170, 172 engage one another such that, in the initial position of
the two clamps 162, 164, the height of the upper clamp 162 is lower
than the height of the upper portion of the corresponding feeder
belt 16; as a result, the feeder belt 16 can be advanced without
being restrained by the upper clamp 162. Referring also to FIGS.
32-33, the cam surfaces 170, 172 are shaped such that, as the upper
clamp 162 is retracted proximally and/or the lower clamp 164 is
advanced distally, the upper clamp 162 is pushed upward into
contact with the feeder belt 16. Such contact provides additional
support for the feeder belt 16 during deployment of the staples
18.
[0087] Referring also to FIGS. 34 and 44, each feeder belt 16 may
be associated with a single clamp 161. Each clamp 161 may be
generally rectangular in shape. The upper surface of each clamp 161
may be substantially as wide as the corresponding feeder belt 16.
Each clamp 161 may be located slightly proximal to the nose 50 or
pulleys 180, or may be positioned differently. Each clamp 161 may
include at least one tab 322 extending downward. Referring also to
FIG. 44, a plurality of slots 324 may extend through the base 62 of
the housing 60, where each slot 324 corresponds to the initial,
unclamped location of a tab 322 of the corresponding clamp 161.
Each tab 322 may be sized to enter the corresponding slot 324
substantially completely, before the feeder belt 16 is clamped.
Optionally, the distal end of at least one slot 324 may include a
ramp 327 sloping upward in the distal direction. Similarly, the
distal end of at least one tab 32 may include a ramp 328 sloping
upward in the distal direction. Referring also to FIG. 45, each
clamp 161 may be fixed or otherwise coupled to the overtube 236,
such that distal motion of the overtube 236 urges the clamps 161
distally to a clamped position, and such that proximal motion of
the overtube 236 urges the clamps 161 proximally to an unclamped
position. As one example, each clamp 161 may include a connector
block 330 at its proximal end, or at any other suitable location.
Both clamps 161 may be connected to the same connector block 330.
Each connector block 330 may be fixed to the overtube 236 in any
suitable manner. As one example, the overtube 236 may include an
aperture between two spaced-apart bent-inward tabs 332 of the wall
of the overtube 236. The overtube 236 may be cut, such as by laser
cutting, to form the aperture and to form the tabs 332. The tabs
332 may be bent inward a sufficient amount to hold the connector
block 330 therebetween during motion of the overtube 236.
Alternately, the clamps 161 may be fixed or otherwise coupled to
the overtube 236 in any other suitable manner.
[0088] Endocutter--Two Staple Rows
[0089] Referring also to FIG. 6, the endocutter 2 described above
includes an end effector 4 configured to place two or more sets of
three rows 26 of staples 18. However, the end effector 4 may be
configured to place two or more sets of different numbers of rows
26 of staples 18, such as by changing the number of rows 26 of
staples 18 on the one or more feeder belts 16. Such an end effector
4 may be configured generally as described above. As one example,
referring to FIGS. 18-20, a feeder belt 16 may include two rows 26
of staples 18. With such a feeder belt 16, one row 26 of staples 18
may be located along each side of the feeder belt 16. As a result,
the feeder belt 16 may be narrower than a feeder belt 16 in which a
third row 26 of staples 18 extends along the center portion of the
feeder belt 16. Thus, by reducing the number of rows 26 of staples
18, the end effector 4 may be reduced in size. For example, the end
effector 4 described above as having three rows 26 of staples 18
may be sized to fit through a trocar port 10 having a 10 mm
diameter passage therethrough, and an end effector 4 having two
rows 26 of staples 18 may be sized to fit through a trocar port 10
having a 5 mm diameter passage therethrough. Referring to FIGS.
18-20, the staples 18 may be shaped, and positioned relative to the
feeder belt 16, substantially as described above with regard to the
feeder belt 16 having three rows 26 of staples 18. Alternately, the
staples 18 may be shaped differently and/or positioned in any other
suitable manner relative to the feeder belt 16. The staples 18 may
be frangibly connected to the feeder belt 16 substantially as
described above. Alternately, the staples 18 may be connected to
the feeder belt 16 in any other suitable manner.
[0090] 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.
[0091] 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.
[0092] Referring to FIG. 21, the configuration of the end effector
4 utilizing feeder belts 16 each having two rows 26 of staples 18
is similar to the configuration of the end effector 4 utilizing
feeder belts 16 each having three rows 26 of staples 18, as shown
in FIG. 16. Referring to FIG. 22, the housing 60 may be configured
similarly to the housing of FIG. 11. The housing 60 includes two
rows of apertures 67 in each top plate 66, corresponding to the two
rows 26 of staples 18 of each feeder belt 16. Due to the presence
of two, rather than three, rows of apertures 67 in each top plate
66, the top plates 66 and thus the housing 60 overall may be
narrower than the housing of FIG. 16. Optionally, at least part of
the housing 60 may omit the top plates 66 and/or inner walls 68.
Referring to FIGS. 23 and 24, the block 84 optionally may be
configured differently than the block 84 of FIG. 14, in order to
fit within a narrower end effector 4. The projection 98 may be
longer in the longitudinal direction than the projection 98 of the
block 84 of FIG. 14. The distal end or other portion of the rod 104
may be attached to the protrusion 98 in any suitable manner. As one
example, the rod 104 may be molded into the protrusion 98. A riser
130 may extend upward from the upper surface 88 of the block 84,
where a knife receiving slot 96 may be defined generally
longitudinally in the riser 130. The riser 130 may be generally
triangular, or may be any other suitable shape. Optionally, the
riser 130 may be connected to or part of the protrusion 98 that
engages the rod 104. A pin 94 may extend laterally across the knife
receiving slot 96 of the riser 130, and engages the hook 92 at the
proximal end of the knife 90. Alternately, the block 84 may be
omitted.
[0093] Two receiving slots 86 may be defined partially into, or
completely through, the block 84, generally as described with
regard to FIG. 14 above. Referring also to FIG. 23A, another
example of a wedge assembly 72 is shown. The wedge assembly 72
includes a tab 78 and an arm 76, as with the wedge assembly 72 of
FIG. 14. However, the wedge assembly 72 of FIG. 23A includes two or
more wedges 74 at its distal end, where the wedges 74 may be spaced
apart laterally from one another and may be generally parallel to
one another. In this way, multiple wedges 74 can be controller by a
single arm 76, reducing the number of parts needed in the end
effector 4 and allowing the end effector 4 to be made narrower. The
wedges 74 may be shaped as set forth with regard to FIG. 14, or may
be shaped in any other suitable manner. The tab 78 of each wedge
assembly 72 of FIG. 23A may be inserted into a corresponding
receiving slot 86 in the block 84 of FIG. 23. Alternately, four
receiving slots 86 may be provided in the block 84 of FIG. 23, and
the wedge assemblies 72 of FIG. 14 may be used. Alternately, the
block 84 may be configured generally as described above and shown
in FIG. 14.
[0094] Two exemplary embodiments of the end effector 4 have been
described above, and in each one the end effector 4 places two sets
of rows 26 of staples 18. However, the end effector 4 may be
configured to place one set, or three or more sets, of rows 26 of
staples 18. Further, the feeder belt 16 may be configured to place
any desired number of rows 26 of staples 18 within a given set of
rows 26. Further, any number of feeder belts 16 may be placed on
either side of the knife 90. The number of feeder belts 16 on one
side of the knife 90 may be the same as, or different from, the
number of feeder belts 16 on the other side of the knife 90. The
number of feeder belts 16 utilized may be related to the type of
tissue that is treated by the end effector 4. The number of rows 26
of staples 18 may be different on each feeder belt 16, or may be
the same on each feeder belt 16. The number of rows 26 of staples
18 on an individual feeder belt 16 may vary along the length of
that feeder belt 16, or may be constant. As another example of an
end effector 4, the knife 90 may be omitted, such that the end
effector 4 is simply a stapler that does not cut tissue. If so, any
suitable number of feeder belts 16 may be utilized.
[0095] Referring to FIGS. 25-27, another exemplary feeder belt 16
having two rows 26 of staples 18 is shown. This feeder belt 16 may
include a plurality of openings 132 defined therein or
therethrough. The openings 132 may be round, or any other suitable
shape. The openings may all be of substantially the same size
and/or shape, and/or may be of different sizes and/or shapes. The
openings 132 may be useful in reducing the moment of inertia of the
feeder belt 16 such that the feeder belt 16 is more flexible and
more easily slides along the nose 50 of the staple holder 30.
Instead, or in addition, one or more of the openings 132 may be
engaged by pins or gears (not shown) in the handle 8 of the
endocutter 2 in order to cause the feeder belt 16 to move. In
addition to, or instead of, the openings 132, the feeder belt 16
may have one or more notches 134 defined in one or more lateral
edges thereof. Each notch 134 may be located adjacent to a tab 28,
or one or more notches 134 may be located differently. The notches
134 also may act to increase the flexibility of the feeder belt 16,
and/or to promote engagement between a mechanism in the handle 8
and the feeder belt 16.
[0096] 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. 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 136. This bump 136 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 138.
The staple 18 then continues to curve upward and proximally until
terminating at a free end 22 at its proximal end.
[0097] Referring also to FIG. 35, another exemplary feeder belt 16
connected to two rows of staples 18 is shown. The feeder belt 16
may include openings therethrough as described above with regard to
FIGS. 25-27, or may omit such openings. One or more staples 18
connected to the feeder belt 16 of FIG. 35 may include a distal leg
194 and a proximal leg 196 connected to the distal leg 194. The
distal leg 194 may be oriented generally perpendicular to the
longitudinal centerline of the feeder belt 16, and the proximal end
of the proximal leg 196 may be oriented generally perpendicular to
the longitudinal centerline of the feeder belt 16. The proximal leg
196 may curve downward in the distal direction toward its
connection to the distal leg 194. Alternately, the distal leg 194
and/pr the proximal end of the proximal leg 196 of the staple 18
may be oriented differently. The distal leg 196 may include a
protrusion 198 extending therefrom. The protrusion 198 may be
located below the connection between the proximal leg 196 and the
feeder belt 16, and may extend in the proximal direction. The
protrusion 198 may extend along part of or substantially all of the
distal leg 194. The protrusion 198 facilitates closure of the
staple 18 during deployment, as described in greater detail below.
The connection between the distal leg 194 of a staple 18 and the
feeder belt 16 may be coined, in order to facilitate separation
between the staple 18 and the feeder belt 16 after closure of the
staple 18. However, the distal leg 194 of at least one staple 18
may be connected to the corresponding feeder belt 16 in any other
suitable manner. The feeder belt 16 and associated staples 18 may
be fabricated in any suitable manner. As one example, the feeder
belt 16 and staples 18 may be stamped from a sheet of stainless
steel or other metal. The junction between at least one staple 18
and the feeder belt 16 may be coined, and the staples 18 then may
be bent substantially ninety degrees relative to the feeder belt
16.
[0098] Referring also to FIGS. 28-28A, the wedge 74 of a wedge
assembly 72 may have a shape that facilitates deployment of the
staples of FIGS. 25-27. The wedge 74 may have a first segment 140
shaped to facilitate deployment of the staple 18, and a second
segment 142 shaped to facilitate shearing or otherwise separating
the staple 18 from the feeder belt 16. The first segment 140 is
curved upward and distally; the curve may have any shape that
facilitates formation of a staple 18. By providing two distinct
segments 140, 142 on the wedge 74, formation and separation of the
staple 18 can be separately controlled, as described in greater
detail below. Referring to FIG. 28, the wedge 74 may include a
first ramp 186 extending upward in the distal direction at a first
angle relative to the longitudinal centerline of the arm 76. The
wedge 74 may include a second ramp 188 extending upward in the
distal direction from the distal end of the first ramp 186, at a
second angle relative to the longitudinal centerline of the arm 76.
The second angle may be more acute than the first angle. The first
segment 140 of the wedge 74 may extend longitudinally along
substantially the length of the second ramp 188, because contact
between the second ramp 188 and a staple 18 closes the staple 18,
as described in greater detail below. The wedge 74 may include a
spacer segment 190 extending distally from the distal end of the
second ramp 188, substantially parallel to and spaced apart from
the longitudinal centerline of the arm 76. Alternately, the spacer
segment 190 may be oriented in a different direction. The wedge 74
may include a third ramp 192 extending distally from the distal end
of the spacer segment 190, extending upward in the distal direction
at a third angle relative to the longitudinal centerline of the arm
76. The second segment 142 of the wedge 74 may extend
longitudinally along substantially the length of the third ramp
192, because contact between the third ramp 192 and a staple 18
shears or otherwise separates the staple 18 from the corresponding
feeder belt 16, as described in greater detail below.
[0099] Handle
[0100] Referring to FIGS. 37-38, the handle 8 may include a housing
214 that protects at least some of the components of the handle 8,
and that defines a space 221 therein for those components. The
housing 214 may include a heel 216 of a trigger grip, which may be
configured to rest in a surgeon's palm during use. The housing 214
may include an axle 218 defined therein, extending into the space
221 within the housing 214. Advantageously, the axle 218 spans the
space 221 such that each end is connected to the housing 214. Two
different triggers may be rotatably mounted on the axle 218. A
clamping trigger 220 may be rotatably mounted on the axle 218. As
one example, an aperture 224 may be defined through a portion of
the clamping trigger 220, such that the axle 218 is received within
the aperture 224. A firing trigger 222 may be rotatably mounted on
the axle 218 as well. As one example, the firing trigger 222 may
include a head portion 226 that includes two laterally-spaced side
walls 228 spaced far enough apart from one another such that the
portion of the clamping trigger 220 adjacent to the aperture 224
can fit between the side walls 228. Each side wall 228 may include
a head aperture 230 defined therein, such that the axle 218 is
received within that aperture 224.
[0101] The clamping trigger 220 includes a grip portion 232
configured for a surgeon to grasp, where that grip portion 232 is
on one side of the aperture 224. On another side of the aperture
224, the clamping trigger 220 includes a clamp arm 234. The clamp
arm 234 may be sized and shaped in any suitable manner. The clamp
arm 234 may be configured to engage an overtube 236, in any
suitable manner. As one example, the overtube 236 includes a curved
engagement feature 238 defined in a surface thereof. The clamp arm
234 may be curved or rounded at its free end in order to smoothly
engage the engagement feature 238 of the overtube 236 as the clamp
arm 234 is rotated about the axle 218. The engagement feature 238
may have a radius of curvature slightly less than the distance
between the axle 218 and the free end of the clamp arm 234, such
that contact between the clamp arm 234 and the engagement feature
238 results in an amount of frictional force sufficient to advance
the overtube 236. The head portion 226 of the firing trigger 222
may include a notch 256 defined therein through which the clamp arm
234 extends into contact with the engagement feature 238. The
overtube 236 extends distally out of the housing 214, and may
include a lumen through which at least part of the shaft 6 extends.
The overtube 236 extends to a position slightly distal to the anvil
32 prior to clamping, such that advancement of the overtube 236
causes the anvil 32 to close, as described in greater detail
below.
[0102] The overtube 236 may be biased in the proximal direction,
such as by a coil spring (not shown) connected to both the overtube
236 and the housing, or in any other suitable manner. A button 240
may be included as a component of the handle 8, where the button
240 is rotatable about a button axle 242 extending from the housing
214. The button 240 may include a stop arm 244 that extends into
the proximal end of the overtube 236. The button 240 may include a
finger pad 248 angularly spaced from the stop arm 248, where the
button 240 may extend out of the proximal end of the housing 216. A
tab 250 may also be angularly spaced from the stop arm 244, where a
coil spring 252 or other biasing element may be fixed to or placed
adjacent to that tab 250. The tab 250 may be oriented toward a
pocket 254 in the housing 214, whereby the pocket 254 holds the
spring 252 in place. The proximal end of the overtube 236 may
include a stop wall 249 extending upward from a lower surface in
the lumen 240 of the overtube 236. As the overtube 236 advances,
the stop arm 244 of the button drops into place proximal to the
stop wall 249 of the overtube 236, preventing the overtube 236 from
moving proximally, and locking the overtube 236 in place. The stop
arm 244 may drop into place proximal to the stop wall 249 as a
result of gravity pulling that stop arm 244 downward, or the stop
arm 244 may be biased downward by the compressive force of the
spring 252 or other mechanism. As used in this document, terms such
as "upward," "downward" and "lateral" refer to local directions
with regard to the drawings and are used for convenience and
clarity; such terms do not limit the orientation of the endocutter
2 in use.
[0103] The firing trigger 222 includes a grip portion 258
configured for a surgeon to grasp, where that grip portion 258 is
on one side of the head aperture 230. The head portion 226 of the
firing trigger 222 includes teeth 260 defined thereon, and a tab
262 angularly spaced apart from the teeth 260. The firing trigger
222 is biased toward an initial position, such as by a coil spring
(not shown) attached to a return pin 284 and to the housing 216.
The return pin 284 may be connected to the firing trigger 222 at a
location on the head portion 226 or any other suitable portion of
the firing trigger 222. The force of the spring or other biasing
member on the return pin 284 creates a moment about the axle 218
that urges the firing trigger 222 outward to an initial pre-firing
position.
[0104] A transmission member 270 may be located within the space
221 within the housing 216, and may include a first rack 272 and a
second rack 274 defined thereon. Each of the first rack 272 and the
second rack 274 include teeth. The first rack 272 includes teeth
configured to engage corresponding teeth 260 of the head portion
226 of the firing trigger 222. The transmission member 270 may have
any suitable shape. As one example, the transmission member 270 may
include a proximal arm 276 from which the first rack 272 extends
downward, and a distal arm 278 from which the second rack 274
extends upward. The distal arm 278 may be located lower than the
proximal arm 276, such that the proximal end of the distal arm 278
forms a wall 280. As the firing trigger 222 is actuated, the head
portion 226 rotates about the axle 218. Such rotation causes the
teeth 260 and tab 262 attached to the head portion 226 to rotate
about the axle 218 as well. The tab 262 may initially be positioned
adjacent to the distal end of the first rack 272. The distal end of
the first rack 272 may include a stop 282 that engages the tab 262
and prevents the tab 262 from moving further proximally. The first
rack 272 may be located proximal to, and spaced apart from, the
wall 280 of the transmission. Thus, as the head portion 226 rotates
about the axle 218, the tab 262 moves away from the first rack 272
and then into engagement with the wall 280 of the transmission 270.
The space between the first rack 272 and the wall 280 of the
transmission provides a safety margin to the firing trigger 222,
such that the endocutter 2 is not inadvertently actuated with only
a small input to the firing trigger 222. Further rotation of the
head portion 226 of the firing trigger 222 causes the tab 262 to
urge the wall 280 of the transmission 270 distally, thereby moving
the transmission 270 as a whole distally. This distal motion moves
the first rack 272 into contact with the teeth 260 of the head
portion 226 of the firing member 222. As a result, further rotation
of the head portion 226 causes the teeth 260 of the head portion
226 to engage the first rack 272 and move the transmission 270
further distally. The overtube 236 may include one or more guide
features 237 defined in the lumen 241 thereof to guide and/or
constrain the motion of the transmission 270. As one example, a
guide feature 237 may be a generally horizontal tab positioned
above and substantially in contact with an upper surface of the
transmission 270. Further, the housing 214 may guide and/or
constrain the motion of the transmission 270. As one example, the
distal end of the transmission 270 may be vertically constrained
between the gear 286 described below and a portion of the housing
214.
[0105] The second rack 274 of the transmission 270 is configured to
engage a gear 286 that has two separate sets of teeth. The second
rack 274 of the transmission 280 engages the first set of teeth 288
of the gear 286, where the first set of teeth 288 form a circular
gear having a first diameter. The second set of teeth 290 form a
circular gear having a second diameter larger than the first
diameter. Alternately, the teeth 288, 290 may be located on
separate gears fixed to one another, rather than on a single gear
286. As the transmission 270 moves distally, the second rack 274
moves distally, engaging the first set of teeth 288 of the gear 286
and causing the gear 286 to rotate. Such rotation in turn causes
the second set of teeth 290 to rotate as well. Referring as well to
FIG. 39, a driver rack 294 includes teeth 296 that are configured
to engage the second set of teeth 290 of the gear 286. During
actuation of the firing trigger 222, the gear 286 rotates in a
direction such that interaction between the second set of teeth 290
of the gear 286 and the teeth 296 of the driver rack 294 urges the
driver rack 294 proximally. Referring to FIGS. 39-40, the driver
rack 294 may be fixed to a driver 300 that extends through the
shaft 6 to the end effector 4. The driver 300 may include an
elongated arm 302 that may have a circular, rectangular, or other
suitable cross-section. The elongated arm 302 may be connected to
the driver rack 294, and may be fixed to the driver rack 294 in any
suitable manner. As one example, the driver rack 294 may include a
generally T-shaped passage 304 defined in proximity to the distal
end thereof. The T-shaped passage 304 is advantageously open at its
distal end, thereby creating an opening 308 at the distal end of
the driver rack 294. The opening 308 may be generally rectangular.
The passage 304 may be oriented in any suitable direction, such as
generally laterally. The elongated arm 302 may include a generally
circular button 306 at its proximal end, with a thin extension bar
310 connecting the button 306 to a remainder of the elongated arm
302. The button 306 may be substantially as thick as the T-shaped
passage 304, such that the button 306 may slide into and
frictionally engage the T-shaped passage 304. The button 306 may be
additionally fixed to the driver rack 294 by adhesive, welding
and/or any other suitable method and/or mechanism. The bar 310 is
sized to slide into the opening 308 of the T-shaped passage 304 as
the button 306 enters the T-shaped passage.
[0106] Referring also to FIGS. 42 and 47, moving distally along the
elongated arm 302 of the driver 300, a depression 312 may be
defined in the upper surface of the elongated arm 302. The
depression 312 extends along a portion of the elongated arm 302. A
pawl 314 may be located at the distal end of the depression 312.
The pawl 314 may be oriented generally proximally and generally
parallel to the longitudinal centerline of the elongated arm 302,
such that it is cantilevered over a distal portion of the
depression 312. Because the pawl 314 is cantilevered over a portion
of the depression 312, it is flexible downward into the depression
312, and may be biased upward in the direction out of the
depression 312. Alternately, the pawl 314 may be configured
differently. The pawl 314 may include an upward-extending stop 316
in proximity to its proximal end, with a ramp 318 extending
proximally and downward from the upper end of the stop 316.
[0107] Moving distally along the elongated arm 302 of the driver
300, referring also to FIG. 43, the distal end of the elongated arm
302 may be connected to a plate 320 that in turn is connected to a
plurality of wedge assemblies 72. Alternately, the elongated arm
302 may be connected directly to at least one wedge assembly 72.
Alternately, a different portion of the elongated arm 302 may be
connected to the wedge assemblies 72, directly or indirectly. The
number of wedge assemblies 72 corresponds to the number of staple
rows deployed by the end effector 4. The plate 320 may be welded,
adhered to, fabricated integrally with, or otherwise positioned on
the underside of the distal end of the elongated arm 302. Each
wedge assembly 72 may be connected to the plate 320 in any suitable
manner. As one example, each wedge assembly 72 may include a tab 78
at or near its proximal end such as seen in FIG. 13, where that tab
78 is configured to be received in a receiving slot in the plate
320 that may be configured in a similar manner as the receiving
slot 86 seen in FIG. 14. Advantageously, the wedge assemblies 72
are fixed to the plate 320 in any suitable manner, such as by
welding, adhesive, friction fitting, interference fitting, and/or
any other suitable methods or mechanisms. Referring back to FIG.
43, at least one wedge 74 may be staggered relative to one or more
other wedges 74. That is, at least one wedge 74 may be positioned
at a distance from the distal end of the elongated arm 302
different from that of at least one other wedge 74. As a result,
where at least one wedge 74 is staggered, the wedges 74 are not
laterally aligned relative to one another. As another example, the
wedges 74 need not be staggered, and each wedge 74 may be
positioned at substantially the same distance from the distal end
of the elongated arm 302. As a result, where the wedges 74 are not
staggered, the wedges are substantially laterally aligned relative
to one another.
[0108] The driver 300 includes the wedge assemblies 72, the
elongated arm 302, the button 306, and the bar 310. Where the
driver 300 of FIG. 43 is utilized, the wedges 74 may be positioned
and oriented relative to the staple holder 30 substantially as
described above, such as with regard to FIGS. 11 and 13. Referring
also to FIG. 36, the proximal end of the knife 90 may be connected
to the driver 300, such as at the plate 320 or the distal end of
the elongated arm 302. As one example, a knife axle 301 is located
at the distal end of the elongated arm 302, and the hook 92 of the
knife 90 engages that knife axle 301 in any suitable manner.
Advantageously, the knife 90 is fixed to the knife axle 301, such
as by welding.
[0109] Referring to FIG. 40, a top plate 340 may extend above the
driver rack 294, without being connected to the driver rack 294.
The top plate 340 may be generally elongated. Referring also to
FIG. 46, the top plate 340 may include one or more ratchet ramps
342 extending downward from an underside thereof. Each ratchet ramp
342 may extend substantially along a center portion of the
underside of the top plate 340, spaced apart from both lateral
edges of the top plate 340. Advantageously, the ratchet ramps 342
may be spaced substantially equidistant from the lateral edges of
the top plate 340. Each ratchet ramp 342 extends downward in the
proximal direction, and may be straight, curved or otherwise
shaped. Alternately, at least one ratchet ramp 342 may be shaped or
oriented differently. At the proximal end of each ratchet ramp 342,
a face 344 may extend upward toward a remainder of the top plate
340. The face 344 may be oriented generally vertically, or may be
oriented in any other suitable direction. Where multiple ratchet
ramps 342 are utilized, another ratchet ramp 342 may begin
immediately proximal to the face 344, or may begin at a location
spaced apart from the face 344. A top plate rack 346 may be located
on the underside of the top plate 340, lateral to the ratchet ramps
342, and advantageously located on both sides of the ratchet ramps
342.
[0110] Referring also to FIG. 47, the top plate rack 346 includes
multiple gear teeth 348 configured to engage one or more spur gears
350. Where the top plate rack 346 includes two sets of gear teeth
348 laterally separated by the ratchet ramp or ramps 342, two spur
gears 350 may be used, one configured to engage each set of gear
teeth 348. The spur gears 350 may be connected to one another by an
axle 352, forming a spur gear assembly 354. The spur gears 350 may
be held in place in any suitable manner. As one example, the
retainer 112 includes a niche 356 in which the spur gears 350 are
held. The niche 356 may include one or more apertures 358 or
depressions each configured to hold an end of the axle 352. The
spur gear or gears 350 are advantageously idler gears that are not
actively driven. However, at least one spur gear 350 may be
actively driven if desired.
[0111] Referring to FIG. 40, the distal end of the top plate 340
may be fixed or otherwise connected to an end of a corresponding
feeder belt 16 in any suitable manner, such as by welding. The
other end of the feeder belt 16 may be fixed or otherwise connected
to a bottom plate 360 in any suitable manner such as by welding.
The bottom plate 360 includes a bottom plate rack 362 including
gear teeth oriented generally upward. The bottom plate 360 may be
thin, and generally elongated. The bottom plate 360 may be
generally parallel to the top plate 340. The gear teeth of the
bottom plate rack 362 of the bottom plate 360 are configured to
engage the one or more spur gears 350. Consequently, motion of the
top plate 340 and bottom plate 360 are coupled in the opposite
direction to one another, as described in greater detail below.
[0112] Operation
[0113] Referring to FIGS. 2-3, at least one trocar port 10 is
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.
[0114] Referring also to FIGS. 1, 16 and 21, the end effector 4 of
the endocutter 2 is introduced into the patient 14 through one of
the trocar ports 10. 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. 29, 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, and/or to transect soft tissue
or organs.
[0115] Referring to FIGS. 16 and 21, 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 in any standard
manner or any other suitable manner. As one example, referring to
FIGS. 37-38, the clamping trigger 220 is compressed toward the heel
216 of the housing 214 of the handle 8. As set forth above, as the
clamping trigger 220 is compressed toward the heel 216 of the
housing 216, the clamp arm 234 rotates about the axle 218 in the
housing 214. This rotation causes the free end of the clamp arm 234
to move partially in the distal direction. The clamp arm 234
engages the overtube 236 during its rotation, and in turn urges the
overtube 236 to advance distally. As a result, the overtube 236
advances distally toward the anvil 32 and the staple holder 30. As
the overtube 236 advances distally, the proximal ends of both the
anvil 32 and the staple holder 30 enter the lumen 241 of the
overtube 236. As the overtube 236 continues to advance, contact
between the distal end of the overtube 236 urges the anvil 32 and
staple holder 30 toward one another. The overtube 236 continues to
advance distally until the anvil 32 and staple holder 30 have moved
together to a final, closed position. The overtube 236 may be used
to close the end effector 4 whether the anvil 32 or staple holder
30, or neither, are substantially fixed relative to a remainder of
the end effector 4 and/or the shaft 6. The use of an overtube to
close an anvil 32 and staple holder 30 is standard in the art.
After the end effector 4 has been closed, the tissue to be treated
is clamped by the end effector 4. The actuation of the end effector
4 to clamp the tissue to be treated may be referred to as
clamping.
[0116] As set forth above, after the end effector 4 is in the
clamped position, the stop arm 244 of the button 240 is urged into
position proximal to the stop wall 249 in the lumen of the overtube
236. The overtube 236 may be biased proximally such as by a coil
spring within the housing 214 connected to both the housing 214 and
the overtube 236, or by any other suitable mechanism or method.
Thus, after the end effector 4 has been clamped, the clamping
trigger 220 may be released. The proximal bias of the overtube 236
attempts to urge the overtube 236 proximally, thereby urging the
stop wall 249 of the overtube 236 into contact against the stop arm
244 of the button 240. This contact holds the overtube 236 in
position, thereby maintaining the end effector 4 in the clamped
position. The surgeon may then remove his or her hand from the
clamping trigger 220, and the end effector 4 remains in the clamped
position.
[0117] Advantageously, prior to the deployment of staples 18, the
feeder belts 16 are clamped into place. By locking the feeder belts
16 into place, the wedges 74 are able to deliver force that deforms
and shears the staples 18, rather than moving or deforming the
feeder belts 16. Referring to FIGS. 44-45, as one example of
clamping the feeder belts 16 in place, distal motion of the
overtube 236 in turn urges the clamps 161 distally, because the
clamps 161 are fixed or otherwise coupled to the overtube 236.
Distal motion of each clamp 161 causes each tab 322 of that clamp
161 to slide upward and distally out of the corresponding slot 324
in the base 62 of the housing 60. Where a tab 322 includes a ramp
328 and the corresponding slot 324 includes a corresponding ramp
327, the ramp 328 of the tab 322 slides up the corresponding ramp
327 of the slot 324, facilitating motion of the clamp 161. The tabs
322 of the clamp 161 then rest on the base 62 of the housing 60,
and the upper surface of the clamp 161 presses upward on the
underside of the corresponding feeder belt 16. In this way, the
feeder belt 16 is clamped into place, and may be tensioned as
well.
[0118] As another example of clamping the feeder belts 16 in place,
referring also to FIGS. 30-33, the sliding clamps 160 are moved to
the second position. Such motion may include sliding the upper
clamp 162 proximally and/or sliding the lower clamp 164 distally.
During the sliding motion, the tongue 168 of the upper clamp 162
slides along the slot 166 of the lower clamp 164. As the upper
clamp 162 and/or lower clamp 164 slide, the cam surfaces 170, 172
engage one another to cause the upper surface of the upper clamp
162 to move upward into contact with the feeder belt 16. Such
contact further stabilizes the feeder belt 16 during contact
between the wedges 74 and the staples 18.
[0119] After clamping, the end effector 4 is configured to deploy
staples 18. Referring also to FIGS. 6, 12 and 43, the wedges 74 are
in an initial position, in which each wedge 74 may be distal to the
staples 18 in the corresponding row 26. Further, referring also to
FIG. 11, at least one staple 18 in each row 26 initially is
positioned under a corresponding aperture 67 in the top plate 66 of
the housing 60. Advantageously, a staple 18 initially is positioned
under each aperture 67 in the top plate 66 of the housing 60.
Referring to FIGS. 14 and 17A, where the block 84 is utilized, the
block 84 is located at or in proximity to the distal wall 124 of
the recess 120, which is the initial position of the block 84.
Alternately, in its initial position the block 84 may be located at
or in proximity to a proximal end of the recess 120, or may be
located differently relative to the recess 120. In a staple holder
30 utilizing the block 84 of FIG. 23, the block 84 may be in an
initial position in the staple holder 30 and/or shaft 6 of the
endocutter 2, where the block 84 is at or in proximity to a distal
end of a recess or space in the staple holder 30 and/or shaft 6.
Alternately, the block 84 may be positioned at or in proximity to a
proximal end of a recess or space in the staple holder 30 and/or
shaft 6, or may be positioned differently relative to the staple
holder 30 and/or shaft 6. Referring to FIGS. 15, 16 and 21, the
knife 90 is in an initial position relative to the staple holder
30, where the cutting edge 110 of the knife 90 may be held
completely within the staple holder 30. At least part of the blade
108 may be held within the staple holder 30 as well. Referring also
to FIG. 8, the blade 108 and cutting edge 110 of the knife 90 may
be located within the distal end 42 of the feeder belt guide
40.
[0120] The user then actuates the firing trigger 222 to deploy the
staples 18 in any suitable manner. As one example, referring to
FIGS. 37-38, and as described above, as the firing trigger 222 is
compressed toward the heel 216 of the housing 214, the tab 262 and
teeth 260 located on the head portion 226 of the clamping trigger
move partially in the distal direction. Engagement between the
teeth 260 and the first rack 272 of the transmission 270 moves the
transmission 270 distally, thereby causing the second rack 274 of
the transmission 270 to rotate the gear 286. Referring also to FIG.
41, the second set of teeth 290 of the gear 286 engage the driver
rack 294 and move the driver rack 294 proximally. Such proximal
motion moves the entirety of the driver 300 proximally, including
the wedges 74.
[0121] As another example, referring to FIG. 24, actuation of the
firing trigger 222 moves the rod 104 proximally by any suitable
mechanism or method. As one example, the proximal end of the rod
104 extends into the handle 8, and a mechanism within the handle 8
moves the rod 104 proximally. The mechanism may be actuated by a
release of energy stored within the handle 8. A mechanism for
moving a rod 104 linearly is standard; any suitable mechanism or
mechanisms may be utilized. Proximal motion of the rod 104 causes
the block 84 to move proximally, as a result of the attachment
between the rod 104 and the protrusion 98 from the block 84. The
proximal motion of the block 84 in turn causes the wedge assemblies
72 and knife 90, which are attached to the block 84, to move
proximally. Alternately, the rod 104 may be rotated instead of, or
in addition to, being retracted proximally, where such rotation
causes proximal motion of the block 84.
[0122] The driver 300 continues to move proximally, such that the
wedge assemblies 72 and wedges 74 move proximally. Proximal motion
of the wedge assemblies 72 in turn causes proximal motion of each
wedge 74, which in turn causes deployment of the staples 18. For
clarity, motion of a single wedge 74 to deploy one or more staples
18 in a corresponding row 26 is described. The wedge 74 may be
initially distal to the staples 18 in the corresponding
generally-linear row 26, and the path of motion of the wedge 74 may
be generally parallel to or collinear with the corresponding row
26. As the wedge 74 moves proximally, the first surface 79 of the
wedge 74 contacts the distalmost staple 18 in the corresponding
row. Referring also to FIG. 5, contact between the first surface 79
and the staple 18 results in the application of force to the staple
18. Because the first surface 79 is angled upward in the distal
direction, that force applied to the staple 18 is exerted both
proximally and upward. Further, the force applied to the staple 18
results in a moment about the tab 28 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 67 in the top
plate 66 of the housing 60 and into the blood vessel 148.
Alternately, where the tab 28 is not used, the force applied to the
staple 18 results in a moment about the location of the connection
of the staple 18 to the feeder belt 16. During motion of the wedge
74, the feeder belt 16 may be held substantially in place, either
passively such as by friction with the corresponding nose 50, or
actively such as by a brake or clutch (not shown) in the handle 8,
shaft 6 and/or end effector 4.
[0123] The wedge 74 continues to move proximally, continuing to
exert a force on the staple 18 that causes a moment 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 (not shown) 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. 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.
[0124] As the wedge 74 continues to move proximally, the peak 82 of
the wedge 74 approaches close to the staple 18, which may be
already completely or substantially completely deformed against the
anvil 32. Alternately, deformation of the staple 18 may continue to
the point where the peak 82 of the wedge 74 contacts the staple 18.
When the peak 82 reaches or comes close to the staple 18, the force
exerted on the staple 18 is primarily in the upward direction.
Further, this force is exerted on the staple 18 at a location at or
in proximity to the tab 28 that connects the staple 18 to the
feeder belt 16. That force shears, breaks or otherwise separates
the staple 18 from the feeder belt 16. The tab 28 is configured
such that the force exerted by the peak 82 of the wedge 74, or by a
portion of the wedge 74 in proximity to the peak 82, is sufficient
to frangibly separate the staple 18 from the feeder belt 16 by
shearing, breaking it off or otherwise separating it. 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 peak 82 may also
actively push, urge or otherwise eject the staple 18 completely out
of the housing 60. Alternately, the staple 18 is passively ejected
from the housing 60, meaning that the staple 18 is not
affirmatively urged out of the housing 60; rather, it is simply
released from the housing 60 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. The second surface 80 does not
substantially contact the staple 18 or tab 28. Alternately, the
second surface 80 may be shaped or otherwise configured to assist
in deformation and/or ejection of the staple 18.
[0125] As another example, the wedge 74 may be configured as shown
in FIG. 28. As stated above, the first segment 140 of that wedge 74
may be shaped to facilitate deployment of the staple 18, and the
second segment 142 of that wedge 74 may be shaped to facilitate
shearing or otherwise separating the staple 18 from the feeder belt
16. As the wedge 74 is moved relative to a staple 18 and contacts
that staple 18, the first segment 140 of the wedge 74 encounters
the staple 18 and applies a force to that staple 18 proximally and
upward to form that staple 18, substantially as described above.
The first segment 140 may be shaped such that formation of the
staple 18 is substantially complete by the time the first segment
140 of the wedge 74 has moved out of contact with the staple 18.
The second segment 142 may have a shape that facilitates separation
of the formed staple 18 from the feeder belt 16. As the wedge 74
continues to move proximally, the first surface 140 moves out of
contact with the staple 18, which is substantially formed, and the
second surface 142 moves into contact with that
substantially-formed staple 18. Where the staple 18 is shaped such
as shown in FIGS. 25-27, after that staple 18 has been
substantially formed, the bump 136 in that staple 18 may be
oriented generally downward and in the path of travel of the second
surface 142. Thus, as the second surface 142 slides proximally, it
applies a force upward against the bump 136, where that force
shears, breaks or otherwise separates the formed staple 18 from the
feeder belt 16.
[0126] As another example, the wedge 74 may be configured as shown
in FIG. 28A, and the staples 18 may be configured as shown in FIG.
35. As the wedge 74 is moved relative to a staple 18 and contacts
that staple 18, the first ramp 186 approaches the staple 18. The
first ramp 186 is shaped and sized to allow the second ramp 188 of
the wedge 74 to encounter and apply a force to the distal leg 196
of the staple 18. As a result, the second ramp 188 applies a force
to that protrusion 198. The protrusion 198 pushes tissue toward the
anvil 32 as the staple 18 closes, promoting closure of the tissue.
Referring also to FIGS. 7A-7B, as the second ramp 188 forces the
distal leg 196 of the staple 18 upward, the free end 22 of the
proximal leg 196 of the staple 18 moves upward into the
corresponding staple forming pocket 204. The free end 22 of the
proximal leg 196 may first encounter the proximal section 206 of
the staple-forming pocket 204, which has a first radius of
curvature. As the staple 18 continues to be deformed by force
applied by the wedge 74 and the free end 22 of the proximal leg 196
continues to be forced upward, the proximal section 206 of the
staple-forming pocket 204 deforms that free end 22. The curvature
of the proximal section 206 facilitates motion of the free end 22
of the proximal leg 196 along the surface of the staple-forming
pocket 204 toward the distal section 208 of that staple-forming
pocket 204. The distal section 208 of the staple-forming pocket 204
has a second radius of curvature shorter than the first radius of
curvature of the proximal section 206 of the staple forming pocket
204. The tighter radius of curvature of the distal section 208
facilitates motion of the free end 22 of the proximal leg 196 of
the staple 18 downward, as part of the closing of the staple 18. As
the second ramp 188 of the wedge 74 forces the free end 22 of the
proximal leg 196 of the staple 18 along the staple forming pocket
204, that wedge 72 also forces the distal leg 194 of the staple 18
upward. The second ramp 188 may be shaped such that formation of
the staple 18 is substantially complete by the time the second ramp
188 of the wedge 74 has moved out of contact with the staple 18.
The second segment 142 may include a third ramp 192 that has a
shape that facilitates separation of the formed staple 18 from the
feeder belt 16. The second segment 142 may be spaced apart a
distance from the first segment 188 by a substantially flat or
otherwise-shaped spaced segment 190. The spacer segment 190 is
advantageously as least as long as the longitudinal dimension of a
substantially-closed staple 18, and is located low enough to
substantially avoid contact with the staple 18. Alternately, the
staple 18 may contact the spacer segment 190 during deployment. As
the wedge 74 continues to move proximally, the first surface 140
moves out of contact with the staple 18, which is substantially
formed, and the third ramp 192 moves into contact with that
substantially-closed staple 18. As the third ramp 192 slides
proximally, it applies a force upward against the distal leg 194 of
the staple 18, where that force shears, breaks or otherwise
separates the formed staple 18 from the feeder belt 16. Where the
junction between the staple 18 and the feeder belt 16 is coin
[0127] .ed, that coining concentrates stress at the junction,
facilitating separation between the staple 18 and the feeder belt
16. The force required to shear, break or otherwise separate a
staple 18 from the corresponding feeder belt 16 may be any suitable
amount of force. As one example, approximately twenty pounds of
force separates the staple 18 from the corresponding feeder belt
16. The separation force is selected to ensure that the staples 18
neither fall off the feeder belt 16 in the middle of deployment nor
require an excessive amount of force to separate.
[0128] After the staple 18 has been separated from the feeder belt
16, the wedge 74 may continue its motion in the proximal direction.
As it does so, 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 74 may
be long enough that, as the wedge 74 has deformed one staple 18 a
substantial amount but that staple 18 has not yet separated from
the feeder belt 16, the wedge 74 engages and begins to deform the
next most distal staple 18. Alternately, the wedge 74 is short
enough that it completely deforms one staple 18, which is then
ejected, before the wedge 74 engages and begins to deform the next
most distal staple 18.
[0129] The block 84 may be controlled to move each wedge assembly
72 and corresponding wedge 74 longitudinally along a fixed
distance, such that a fixed number of staples 18 is deployed by
each wedge 74 during each actuation. As a result, referring also to
FIG. 29, the length of each staple line 146 in a blood vessel 148
or other tissue is fixed. The term "staple line" refers to the
grouping of staples 18 in a row 26 after their ejection into
tissue. The block 84 may be controlled to move along a fixed
distance in any suitable manner. As one example, the rod 104 is
movable proximally along that fixed distance during each actuation
of the endocutter 2. Each fixed number of staples 18 in a row 26
may be grouped together and separated from an adjacent group of
staples 18 by a blank space on the feeder belt 16, where that blank
space may have any suitable length. The blank space allows the
wedge 74 to be long enough in the longitudinal direction to engage
and begin to deform a second staple 18 while that wedge 74 is still
completing the deformation and/or ejection of the previous staple
18. Thus, when the wedge 74 moves proximally far enough to
encounter the blank space, no staple 18 is present for that wedge
74 to deform, such that the wedge 74 can complete deformation of
each staple 18 in the group without leaving a subsequent staple 18
partially deformed. However, the wedge may be short enough that it
completely deforms one staple 18, which is then ejected, before the
wedge 74 engages and begins to deform the next most distal staple
18.
[0130] Alternately, the block 84 may be selectively controlled to
move each wedge assembly 72 and corresponding wedge longitudinally
along a selectable distance, such that a selected number of staples
18 may be deployed by each wedge 74 during actuation. In this way,
the length of the staple line 146 in a blood vessel 148 or other
tissue is variable, and selectable by the user. The block 84 may be
selectively controlled in any suitable manner. As one example, the
rod 104 is movable proximally along a distance selectable by the
user during each actuation of the endocutter 2. The rod 104 may be
actuated to move along that selected distance by the handle 8,
which also may be configured to receive user input related to the
selected distance. The handle 8 may be configured in any suitable
manner to control the longitudinal distance of travel of the rod
104. As one example, the handle 8 may include a stepper motor
attached to the rod 104 that translates the rod 104 a selected one
of a discrete number of lengths. As another example, the handle 8
may include a mechanical stop that is movable by the user, where
the rod 104 stops its proximal motion when it encounters the
mechanical stop. That is, the rod 104 may be spring-loaded or
biased across a distance at least as long as the longest selectable
staple line 146, and the mechanical stop is used to stop travel of
the rod 104 at a distance less than the longest selectable staple
line 146. Because the distance across which the wedge 74 travels
may vary during each actuation and is user selectable,
advantageously no blank spaces are present in each feeder belt 16.
In addition, the wedge advantageously may be short enough that it
completely deforms one staple 18, which is then ejected, before the
wedge 74 engages and begins to deform the next most distal staple
18.
[0131] Referring to FIGS. 11-12, 14-17 and 36, as the driver 300 or
block 84 moves proximally, it also moves the knife 90, which is
connected to the driver 300 or block 84 via the hook 92 or other
structure at the proximal end of the knife 90. As the knife 90
moves proximally, it cuts the tissue held between the anvil 32 and
the staple holder 30. The knife 90 may cut that tissue while the
staples 18 are being deformed and ejected. In the initial position
of the knife 90, the blade 108 is located completely within the
staple holder 30, such that the blade 108 does not extend out of
the staple holder 30. In this way, the blade 108 does not
prematurely engage tissue, or pose a hazard to the surgeon. As the
knife 90 moves proximally from its initial position, the bottom of
the blade 108 of the knife 90 may engage and ride up the ramp 116
at the distal end of the retainer 112. As the blade 108 rides up
the ramp 116, at least part of the cutting edge 110 of the blade
108 moves above the top plates 66 of the housing and begins to cut
tissue held between the anvil 32 and the staple holder 30. After
the blade 108 reaches the top of the ramp 116, it continues to move
proximally along the upper surface of the extension 114 as the
block 84 continues to pull the knife 90 proximally. Referring also
to FIG. 7A, where the anvil 32 includes a slot 210 defined in its
inner surface 210, the upper end of the blade 108 may enter and
slid along that slot 210 as the knife 90 moves proximally. The slot
210 may provide lateral stability to the blade 108 as it translates
proximally. At least part of the blade 108 may slide between the
inner walls 68 of the housing as the knife 90 is pulled proximally.
Alternately, the blade 108 may be completely above the inner walls
68 of the housing, or may move in a different manner. Alternately,
the ramp 116 and the extension 114 may be omitted, and the cutting
edge 110 of the blade 108 may be controlled to rise above the top
plates 66 of the housing 60 in another manner. Alternately, the
blade 108 may be controlled to move substantially only in the
longitudinal direction, such that the blade 108 does not
substantially move in the vertical direction. Where the knife 90
includes a cam surface 107 on its upper edge, the cam surface 107
may be located proximal to the cam engagement feature 212 in the
slot 210, such that the cam surface 107 does not engage the cam
engagement feature 212 during proximal motion of the knife 90.
Alternately, the can surface 107 of the knife 90 may engage the cam
engagement feature 212 during at least part of the proximal motion
of the knife 90.
[0132] After the fixed or selected number of staples 18 have been
deformed and ejected, motion of the block 84 stops. At this time,
the firing trigger 222 may be locked into position by the stop arm
244 of the button 240, by a different part of the button 240, or by
a different mechanism. When motion of the block 84 stops, the block
84, wedges 74 and blade 108 are each in a final position. The blade
108 is sized and shaped such that the blade 108 has completely cut
through the tissue held between the anvil 32 and the staple holder
30 when the blade 108 is in the final position. In the final
position, at least one wedge 74 and/or the blade 108 may be
proximal to the corresponding receiving space 70 in the housing 60.
Alternately, the wedges 74 and/or blade 108 may remain within the
corresponding receiving space 70 in the housing 60 in their final
position.
[0133] As another example of actuation of the endocutter 2, the
wedge 74 may be initially proximal to the staples 18 in the
corresponding row 26, and the wedge 74 is moved distally rather
than proximally to deploy one or more staples 18 in that row 26.
Such distal motion of the wedge 74 may be caused by, for example,
moving the rod 104 in the distal direction. Where the wedge 74 is
moved distally to deploy staples 18, the first surface 79 and the
second surface 80 of the wedge 74 may be shaped differently in
order to deploy the staples 18 properly. Further, the staples 18
may be oriented backward relative to the feeder belt 16, such that
the free end 22 of each staple 18 is located distal to the point of
attachment between the staple 18 and the feeder belt 16. The other
aspects of operation of the staple holder 30 also are performed
substantially in reverse order from the order described above, in
order to deform the staples 18 and separate them from the feeder
belt 16.
[0134] After the fixed or selected number of staples 18 have been
deformed and ejected, and the cutting edge 110 of the blade 108 has
transected the tissue held between the anvil 32 and the staple
holder 30, the end effector 4 is unclamped, releasing the tissue.
Referring also to FIG. 29, where that tissue is a blood vessel 148,
the blood vessel 148 has been transected into two segments, each of
which has staggered rows of staples 18 forming a staple line 146
near an end thereof. Each wedge 74 actuated staples 18 in the
corresponding row 26, and as set forth about the staples 18 and the
apertures 67 in the top plate 66 of the housing 60 are staggered.
By staggering the rows 26 of staples 18 in a staple line 146,
hemostasis at the end of the blood vessel 148 is facilitated,
because the leak path is longer in length and more convoluted than
if the rows 26 of staples 18 were not staggered.
[0135] The end effector 4 may be unclamped in any suitable manner.
As one example, referring to FIGS. 7 and 37, the anvil 32 and the
staple holder 30 may be biased apart from one another to an open
position, such that sliding the overtube 236 proximally unclamps
the end effector 4 and allows the anvil 32 and staple holder 30 to
open. The overtube 236 itself may be unlocked from the position it
maintains while the end effector 4 is in the clamped position in
any suitable manner. As one example, referring also to FIG. 38, in
order to allow the overtube 236 to slide proximally, the surgeon
may depress the finger pad 248 of the button 240. This depression
rotates the stop arm 244 of the button 240 upward out of contact
with the stop wall 249 of the overtube 236, such that contact
between the stop arm 244 and the stop wall 249 no longer restrains
the overtube 236 against proximal motion. As described above, the
overtube 236 may be biased in the proximal direction, such that
movement of the stop arm 244 out of contact with the stop wall 249
of the overtube 236 results in proximal motion of the overtube
236.
[0136] Proximal motion of the overtube 236 may release the anvil 32
and staple holder 30, unclamping the end effector 4. Proximal
motion of the overtube 236 may also reset the end effector 4 for
another firing, during unclamping of the end effector 4 from the
previous firing. By automatically resetting the endocutter 2 for
another firing during unclamping from the previous firing, use of
the endocutter 2 is simplified, and the surgeon need not undertake,
or remember, additional actions to reset the endocutter for another
firing. Proximal motion of the overtube 236 may also reset the
clamps 161 to their initial, prefiring positions. Referring also to
FIGS. 44-45, as the overtube 236 moves proximally, it moves the
clamps 161 coupled thereto in the proximal direction as well.
Proximal motion of each clamp 161 causes each tab 322 of that clamp
161 to slide downward and proximally into the corresponding slot
324 in the base 62 of the housing 60. Where a tab 322 includes a
ramp 328 and the corresponding slot 324 includes a corresponding
ramp 327, the ramp 328 of the tab 322 slides down the corresponding
ramp 327 of the slot 324, facilitating motion of the clamp 161 in a
manner that moves the upper surface of the clamp 161 out of
engagement with the corresponding feeder belt 16. The tabs 322 of
the clamp 161 then rest in the corresponding slots 324. As the
overtube 236 moves proximally, contact between the engagement
feature 238 of the overtube 236 and the free end 234 of the
clamping trigger 220 rotates the clamping trigger 220 about the
axle 218, urging the grip portion 232 of the clamping trigger 220
away from the heel 216 of the housing 214. In this way, the
clamping trigger 220 is reset for subsequent clamping of the end
effector 4 at a different location.
[0137] Referring also to FIGS. 37-38, the firing trigger 222 may be
reset at substantially the same time as the clamping trigger 220.
The firing trigger 222 may be released by depression of the finger
pad 248 of the button 240, or in any other suitable manner. The
firing trigger 222 may be biased outward to its initial position.
As another example, motion of the clamping trigger 220 away from
the heel 216 of the housing 214 forces the firing trigger 222
outward from the heel 216 as well, or assists in moving the firing
trigger 222 away from the heel 216. As the firing trigger 222 moves
away from the heel 216 of the housing 214, the tab 262 and teeth
260 located on the head portion 226 of the clamping trigger move
partially in the proximal direction. Engagement between the teeth
260 and the first rack 272 of the transmission 270 moves the
transmission 270 proximally, thereby causing the second rack 274 of
the transmission 270 to rotate the gear 286. Referring also to FIG.
41, the second set of teeth 290 of the gear 286 engage the driver
rack 294 and move the driver rack 294 distally. Such distal motion
moves the entirety of the driver 300 distally, including the wedges
74. The distal motion continues until the driver 300 is in the
initial, pre-firing position. As described above, the knife 90 may
be fixed to the driver 300. As a result, as the driver 300 moves
distally, it urges the knife 90 distally as well. Referring also to
FIG. 36, as the knife 90 moves distally, the cam surface 107 of the
knife 90 may engage the cam engagement feature 212 within the slot
210 of the anvil 32. Engagement between the angled cam surface 107
and the cam engagement feature 212 acts to move the blade 108 of
the knife 90 downward as the knife 90 moves proximally. The blade
108 moves downward into the initial position, completely within the
staple holder 30 such that the blade 108 does not extend out of the
staple holder, as the knife 90 moves toward its final, distal-most
position. Alternately, the knife 90 may be moved back to its
initial position in any other suitable manner.
[0138] Referring to FIGS. 8-10 and 14-17, as another example, the
handle 8 may be actuated to return the block 84 to its initial
position after the end effector 4 has been returned to its open
position. Alternately, the block 84 is returned to its initial
position when the end effector 4 returns to its open position, or
at a different time. The rod 104 may be moved in the proximal
direction to return the block 84 to its initial position.
Alternately, the block 84 may be returned to its initial position
in any other suitable manner. As one example, the block 84 may be
biased distally, such that the rod 104 may be released and the
block 84 automatically returns to the initial position. As another
example, the block 84 may be biased proximally, such that the rod
104 is not affirmatively moved proximally to deploy and eject the
staples 18. If so, the rod 104 then may be used to push the block
84 distally to its initial position and hold the block 84 in that
initial position. Alternately, the block 84 may be returned to its
initial position in any other suitable manner. As the block 84
moves back to its initial position, it moves the wedges 74 and the
blade 108 back to their initial positions, reversing the paths
traveled by the wedges 74 and blade 108 during actuation of the end
effector 4. Alternately, the wedges 74 and/or blade 108 may move in
a different manner and/or along a different path to return to their
initial positions. Because the staples 18 that would otherwise be
in the path of the wedges 74 have been deployed out of the housing
60, the wedges 74 may return to their initial position
substantially without interference. Further, because the tissue has
been released from the end effector 4, the blade 108 returns to its
initial position substantially without contacting tissue.
[0139] At this point, the wedges 74 and blade 108 are in their
initial positions. Next, if the feeder belt 16 was restrained
against motion during the previous actuation of the end effector 4
by the sliding clamps 160, those sliding clamps are returned to the
first position, in which the upper claim 162 does not restrain the
feeder belt 16. Such motion may include sliding the upper clamp 162
distally and/or sliding the lower clamp 164 proximally. During the
sliding motion, the tongue 168 of the upper clamp 162 slides along
the slot 166 of the lower clamp 164. As the upper clamp 162 and/or
lower clamp 164 slide, the cam surfaces 170, 172 engage one another
to cause the upper surface of the upper clamp 162 to move downward
out of contact with the feeder belt 16, to allow the feeder belt 16
to advance. If a different or additional restraint such as a brake
or clutch in the handle 8, shaft 6 or end effector 4 was used, that
restraint is released.
[0140] As the endocutter 2 the feeder belt 16 are moved in order to
advance fresh staples 18 into the housing 60 of the staple holder
30. This motion of the feeder belt 16 may be referred to as
"advancing" the feeder belt 16, regardless of the fact that some or
all of the feeder belt 16 may be moved in a direction other than
distally during that advancing. Advancing the feeder belt 16 may be
accomplished in any manner. Each feeder belt 16 may be routed
around a corresponding pulley 180 or nose 50, along a path that
starts generally straight and in the distal direction, then is
curved along the surface of the corresponding pulley 180 or nose
50, and then is generally straight and in the proximal direction,
such that the pulley 180 or nose 50 changes the direction of motion
of the corresponding feeder belt 16 from generally distal to
generally proximal. As a result, referring also to FIG. 35, each
continuous feeder belt 16 may include an upper section 366 and a
lower section 368 substantially parallel to the upper section 366.
The distal end of the top plate 340 may be fixed to the proximal
end of the upper section 366 of a feeder belt 16, and the distal
end of the bottom plate 360 may be fixed to the proximal end of the
lower section 368 of the feeder belt 16. Referring also to FIGS.
46-47, the top plate rack 346 and the bottom plate rack 362 each
engage one or more spur gears 350, as described above. Referring
also to FIG. 42, as the driver 300 moves distally during the reset
process, as described above, the pawl 314 of the driver 300 moves
distally as well. As the pawl 314 moves distally, the stop 316 of
the pawl 314 engages a face 344 of a corresponding ratchet ramp 342
of the top plate 340. As a result, continued distal motion of the
pawl 314 urges that face 344 distally, thereby urging the top plate
340 distally. This distal motion of the top plate 340 causes the
top plate rack 346 to rotate the corresponding spur gear or gears
350, which in turn causes the bottom plate rack 362 and hence the
bottom plate 360 to move distally. Such distal motion of the bottom
plate 360 pulls the lower section 368 of the feeder belt 16
proximally. As the lower section 368 of the feeder belt 16 moves
proximally, the feeder belt 16 is pulled around the corresponding
pulley 180 or nose 50. The use of the pulley 180 may reduce
friction and thereby may reduce the amount of force needed to pull
the feeder belt 16 as compared to the use of the nose 50. As the
lower section 368 of the feeder belt 16 moves proximally, the upper
section 366 of the feeder belt thereby moves distally, moving a
fresh, unfired set of staples 18 into the housing 60. Each feeder
belt 16 is thus reset for another firing of the end effector 4.
Further, each feeder belt 16 is thus automatically reset upon
unclamping of the end effector 4.
[0141] As another example, referring also to FIG. 25, one or more
openings 132 in the feeder belt 16 are engaged by one or more
gears, pins or other mechanisms, such that engagement with the
openings 132 is used to advance the feeder belt 16. As another
example, any other suitable mechanism, structure or method may be
used to move the feeder belt 16 in order to advance fresh,
undeployed staples 18 into the housing 60. Where the feeder belt 16
is movable generally linearly, and the nose 50 is not utilized, the
housing 60 may be longer, and the feeder belt 16 is simply advanced
or retracted generally linearly in order to advance fresh staples
18 into the housing 60.
[0142] The feeder belt 16 may be advanced with or without feedback.
As an example of advancing the feeder belt 16 without feedback, a
stepper motor or other mechanism may be used to advance the feeder
belt 16 a fixed distance each time. Where feedback is provided, the
feeder belt 16 is advanced a distance that is related to the
feedback; that distance may not be fixed every time. As one
example, a pinwheel (not shown) may be configured to engage the
openings 132 in the feeder belt 16 with pins, such that motion of
the feeder belt 16 causes the pinwheel to rotate. Such rotation of
the pinwheel may produce mechanical or electrical feedback that is
transmitted mechanically or electrically to the handle 8, such that
advancement of the feeder belt 16 continues until the pinwheel has
rotated a particular amount. In this way, the pinwheel provides
confirmation that the feeder belt 16 has in fact advance to a
position in which unfired staples 18 are in position in the housing
60 at locations corresponding to the apertures 67 in the top plates
66 of the housing 60. As another example of feedback, an optical
sensor or sensors (not shown) may be positioned in the end effector
4 to sense the openings 132, such that the optical sensor or
sensors can determine the degree of advancement of the feeder belt
16. As another example, any other suitable mechanism may be used to
generate feedback and to transmit that feedback in mechanically,
electrically and/or as data to a suitable controller, which may be
located in the handle 8 or in any other portion of the endocutter.
The controller may be a cam, an integrated circuit, a
microprocessor, an analog circuit or circuits, a digital circuit or
circuits, a mechanical computer, or any other suitable
controller
[0143] Next, the endocutter 2 may be fired again substantially as
described above. Referring to FIGS. 42 and 46-47, upon refiring the
endocutter 2, the driver 300 moves proximally, thereby moving the
pawl 314 proximally. The pawl 314 moves proximally relative to a
ratchet ramp 342 of the top plate 340, thereby gradually flexing
the pawl 314 downward away from the top plate 340. The pawl 314
then moves proximal to the face 344 at the proximal end of that
ratchet ramp 342 and springs back upward, such that the stop 316 is
proximal to the face 344. In this way, the stop 316 of the pawl 314
is prevented from moving distally past the face 344 without moving
the face 344 to ratchet the top plate 340, as described above. The
endocutter 2 may be fired again without removing the end effector 4
from the patient, changing a cartridge or other disposable staple
holder, or reloading the end effector 4 from outside the endocutter
2. 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. 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. 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. At such time, the end effector 4 optionally may be
locked out in any suitable manner, such as by preventing clamping
of tissue, or preventing actuation of the firing trigger 222.
[0144] 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. That is, an endocutter 2 having two rows 26 of
staples 18 on a feeder belt 16, or more than three rows of staples
18 on a feeder belt 16, may be actuated substantially as described
above.
[0145] Driverless Endocutter and Operation
[0146] Optionally, referring to FIGS. 12, 13 and 28, the wedges 74
may be fixed in place relative to the staple holder 30. For
example, the wedges 74 may simply be molded, cut, formed or
otherwise fabricated as part of the feeder belt guide 40 or other
component of the end effector 4. As each feeder belt 16 is
advanced, the most distal unformed staple 18 in each row 26
contacts the stationary wedge 74. The feeder belt 16 then does not
stop, but continues to move. As the feeder belt 16 continues to
advance, the relative motion between the feeder belt 16 and the
stationary wedge 74 causes the staple 18 to deform and then
separate from the feeder belt 16, in substantially the same manner
as described above with regard to motion of the wedge 74 relative
to the substantially stationary feeder belt 16. Where the wedges 74
are stationary, the end effector 4 does not apply a row of staples
18 longitudinally along a staple line. Instead, the end effector 4
sequentially deploys the distalmost staple 18 in each row 26 as the
feeder belt 16 pulls that staple 18 onto the corresponding wedge
74.
[0147] Alternately, for a single-use device, a number of wedges 74
equal to the number of staples 18 to be deployed are fabricated as
part of the end effector 4, and are each located immediately
proximal or distal to the corresponding staple 18. As the feeder
belt 16 is moved longitudinally, each staple 18 contacts the
corresponding fixed wedge 74, deforms to a closed configuration,
and then separates from the feeder belt 16. In this way, two or
more staples 18 can be deployed along a staple line at the same
time, without the use of wedge assemblies 72. Optionally, the
wedges 74 may be movable downward or in another direction from a
first position after deploying the staples 18, such that a feeder
belt 16 can be advanced to place new, undeployed staples 18 in
position for firing, after which the wedges 74 may be moved back to
their first position.
[0148] Other Surgical Tools Utilizing Feeder Belt
[0149] As described above, the feeder belt 16 and attached staples
18 of FIGS. 4-6, 18-20, 25-27, and 30-33 may be used in the end
effector 4 of an endocutter 2. However, the feeder belt 16 and
attached staples 18 may be used in any suitable surgical tool, for
human or veterinary use. As one example, the feeder belt 16 and
attached staples 18 may be used in an anastomosis tool, such as
described in U.S. patent application Ser. No. 11/054,265, filed on
Feb. 9, 2005 (the "'265 application"), which is hereby incorporated
by reference in its entirety. For example, the feeder belt 16,
attached staples 18, and any other suitable part of the mechanism
described above may be placed in each arm 402 of the staple holder
38 of the '265 application in lieu of the sled 482, staples 464,
connector bays 448, connector deployers 452, and/or other
structures and/or mechanisms described in the '265 application as
being present in the arm 402. As a result, the anastomosis tool of
the '265 application may be actuated multiple times. Further, the
arms 402 of the staple holder 38 of the '265 application may be
made smaller due to the smaller size of the staples 18 and the
reduced amount of space required to hold the feeder belt 16,
allowing for the anastomosis of smaller vessels to one another, and
allowing the staple holder 38 to access areas of the body that a
larger staple holder could not. As another example, the feeder belt
16 and attached staples 18 may be used in an end-to-end anastomosis
stapler, such as described in U.S. Pat. No. 6,942,675 (the "'675
patent"), which is hereby incorporated by reference in its
entirety. For example, the feeder belt 16 and attached staples 18
may be placed in each arm 22, 24 of the anastomosis tool 30, in
lieu of any or all of the mechanisms and/or structures described in
the '675 patent as being present in the arms 22, 24. As a result,
the anastomosis tool 30 may be made smaller, facilitating the
end-to-end connection of a greater range of vessels, thereby
further facilitating the performance of microsurgery. The
anastomosis tool 30 may be placed adjacent to the vessels to be
connected, such as blood vessels, and actuated as described in the
'675 patent, where the deployment of staples 18 may be performed
substantially as described above.
[0150] As another example, the feeder belt 16 and attached staples
18 may be used in an intravascular stapler, such as described in
U.S. patent application Ser. No. 11/158,413 (the "'413
application"), which is hereby incorporated by reference in its
entirety. For example, the feeder belt 16, attached staples 18, and
any other suitable part of the mechanism described above may be
placed in the housing 14 of the stapler head 8 in lieu of any or
all of the mechanisms and/or structures described in the '413
application as being present in the housing 14 of the stapler head
8. As a result, the stapler head 8 of the '413 application may be
made smaller, facilitating intravascular access to a greater range
of blood vessels. The stapler head 8 may be placed adjacent to
vascular tissue, and actuated as described in the '413 application,
where the deployment of staples 18 may be performed substantially
as described above.
[0151] As another example, the feeder belt 16 and attached staples
18 may be used in a bariatric or gastrointestinal stapler, such as
used in a gastric bypass procedure or other procedures performed on
the digestive system. The stapler may be placed adjacent to
gastrointestinal tissue, such as the stomach, the small intestine
or the large intestine, and the deployment of staples 18 may be
performed substantially as described above.
[0152] The feeder belt 16 and attached staples 18 may be used in
any suitable surgical tool, regardless of whether that tool
includes a knife 90 or other structure, mechanism or method for
incising or cutting tissue. As one example, the feeder belt 16 and
attached staples 18 may be used in a skin stapler for closing a
pre-existing wound or incision. The skin stapler may be placed
adjacent to the skin, and the deployment of staples 18 may be
performed substantially as described above.
[0153] 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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