U.S. patent application number 16/818252 was filed with the patent office on 2020-07-09 for end effectors, surgical stapling devices, and methods of using same.
The applicant listed for this patent is Standard Bariatrics, Inc.. Invention is credited to Russell L. Holscher, Richard P. Nuchols, Bennie Thompson, Jonathan Thompson.
Application Number | 20200214703 16/818252 |
Document ID | / |
Family ID | 54241134 |
Filed Date | 2020-07-09 |
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United States Patent
Application |
20200214703 |
Kind Code |
A1 |
Thompson; Jonathan ; et
al. |
July 9, 2020 |
END EFFECTORS, SURGICAL STAPLING DEVICES, AND METHODS OF USING
SAME
Abstract
An end effector for use by a surgeon to staple an anatomical
structure of a patient during a surgical procedure includes an
anvil and a cartridge. The anvil has an anvil face and a first
staple pocket defined by the anvil face, where the first staple
pocket comprises a first cup and a second cup for staple formation.
The cartridge has a first staple, the first staple having a first
open leg with a first tip, a second open leg with a second tip, and
a first crown coupling the first open leg and the second open leg,
and a first driver. The first staple, once deployed by the first
driver and deformed by the first staple pocket, comprises the first
tip and the second tip crossing the first midline axis of the first
crown in a formed configuration.
Inventors: |
Thompson; Jonathan;
(Cincinnati, OH) ; Thompson; Bennie; (Blue Ash,
OH) ; Nuchols; Richard P.; (Williamsburg, OH)
; Holscher; Russell L.; (Maineville, OH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Standard Bariatrics, Inc. |
Cincinnati |
OH |
US |
|
|
Family ID: |
54241134 |
Appl. No.: |
16/818252 |
Filed: |
March 13, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16538480 |
Aug 12, 2019 |
10624638 |
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16818252 |
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15633399 |
Jun 26, 2017 |
10405860 |
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16538480 |
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15129366 |
Sep 26, 2016 |
9724096 |
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PCT/US15/22990 |
Mar 27, 2015 |
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15633399 |
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62046726 |
Sep 5, 2014 |
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61972274 |
Mar 29, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/07235
20130101; A61B 2017/2939 20130101; A61B 2017/2927 20130101; A61B
2017/07271 20130101; A61B 2017/07221 20130101; A61B 2017/2919
20130101; A61B 2017/00477 20130101; A61B 2017/07242 20130101; A61B
2017/07278 20130101; A61B 2017/0725 20130101; A61B 2017/07214
20130101; A61B 2017/00876 20130101; A61B 2017/07257 20130101; A61B
2017/07285 20130101; A61B 2017/2937 20130101; A61B 17/07207
20130101 |
International
Class: |
A61B 17/072 20060101
A61B017/072 |
Claims
1. An end effector for a medical device, the end effector
comprising: (a) an anvil, the anvil comprising; (i) a first anvil
end, (ii) a second anvil end, (iii) an anvil face, (iv) a first
staple pocket defined by the anvil face, wherein the first staple
pocket comprises a first cup and a second cup for staple formation;
(v) a second staple pocket defined by the anvil face, wherein the
second staple pocket comprises a third cup and a fourth cup for
staple formation; and (b) a cartridge coupled with the anvil, the
cartridge comprising; (i) a first cartridge end, (ii) a second
cartridge end, (iii) a cartridge face, (iv) a first staple, the
first staple having a first open leg with a first tip, a second
open leg with a second tip, and a first crown coupling the first
open leg and the second open leg, wherein the first crown is
bisected by a first midline axis parallel with the first open leg
and the second open leg, (v) a first driver, the first driver being
operably configured to deploy the first staple, wherein a first
staple formation distance is defined by a first distance between
the first driver and the first cup of the first staple pocket when
the anvil and the cartridge are in a closed position, (vi) a second
staple, the second staple having a third open leg with a third tip,
a fourth open leg with a fourth tip, and a second crown coupling
the third open leg and the fourth open leg, wherein the second
crown is bisected by a second midline axis parallel with the third
open leg and the fourth open leg, (vii) a second driver, the second
driver being operably configured to deploy the second staple,
wherein a second staple formation distance is defined by a second
distance between the second driver and the third cup of the second
staple pocket when the anvil and the cartridge are in the closed
position, wherein the first staple formation distance differs from
the second staple formation distance; and wherein the first staple,
once deployed by the first driver and deformed by the first staple
pocket, comprises the first tip and the second tip crossing the
first midline axis of the first crown in a formed
configuration.
2. The end effector of claim 1, wherein the first staple, once
deployed by the first driver and deformed by the first staple
pocket, has a substantially pretzel-shaped configuration.
3. The end effector of claim 1, wherein a portion of the anvil face
is angled relative to a portion of the cartridge face.
4. The end effector of claim 1, wherein the first tip and the
second tip of the first staple do not cross a longitudinal axis,
extending along the first crown, in the formed configuration.
5. The end effector of claim 1, wherein the first driver and the
second driver have a different configuration.
6. The end effector of claim 1, wherein the anvil face comprises a
stepped configuration having a first segment and a second segment
that are offset.
7. The end effector of claim 1, wherein the first staple formation
distance is provided at a proximal end of the end effector and the
second staple formation distance is provided at a distal end of the
end effector.
8. The end effector of claim 1, wherein the first staple formation
distance corresponds with a first longitudinal row of staple
pockets and drivers and the second staple formation distance
corresponds with a second longitudinal row of staple pockets and
drivers.
9. The end effector of claim 1, further comprising a first wedge
operably configured to actuate the first driver and a second wedge
operably configured to actuate the second driver, wherein the first
wedge and the second wedge have the same configuration.
10. The end effector of claim 1, wherein the first open leg and the
second open leg of the first staple have different lengths.
11. The end effector of claim 10, wherein the first cup and the
second cup of the first staple pocket have different
configurations.
12. The end effector of claim 11, wherein the first cup has a first
arc with a radius of from 0.040 inches to 0.060 inches and a first
depth of from 0.010 inches to 0.030 inches, and the second cup has
a second arc with a radius of from 0.030 inches to 0.050 inches and
a second depth of from 0.010 to 0.030 inches.
13. The end effector of claim 1, wherein the first driver has a
first driver height different from a second driver height of the
second driver.
14. The end effector of claim 1, wherein a first zone of the end
effector comprises the first staple formation distance and a second
zone of the end effector comprises the second staple formation
distance.
15. The end effector of claim 1, further comprising a plurality of
staple formation distances.
16. The end effector of claim 1, wherein the first driver and the
second driver have the same configuration and the first staple
pocket and the second staple pocket have a variable depth.
17. The end effector of claim 1, wherein the first staple pocket
and the second staple pocket have the same configuration and the
first driver and the second driver have a variable height.
18. An end effector for a medical device, the end effector
comprising: (a) an anvil that includes a first end, a second end,
and an anvil face defining a plurality of staple pockets, wherein
each of the plurality of staple pockets comprises a surface for
staple formation; and (b) a cartridge comprising a first end, a
second end, a cartridge face, and a plurality of drivers, each of
the plurality of staple pockets and staple drivers being arranged
in rows and columns, wherein the cartridge is coupled to the anvil;
(c) a first staple, the first staple comprising a first open leg
having a first tip, a second open leg having a second tip, and a
crown bisected by a midline axis parallel with the first open leg
and the second open leg; (c) a first staple formation distance from
a first driver of the plurality of drivers to a first staple pocket
surface from the plurality of staple pockets when the anvil and the
cartridge are in a closed position; (d) a second staple formation
distance from a second driver of the plurality of drivers to a
second staple pocket surface from the plurality of staple pockets
when the anvil and the cartridge are in the closed position,
wherein the first staple formation distance differs from the second
staple formation distance; and wherein the first staple, once
deployed, comprises the first tip and the second tip crossing the
midline axis of the crown in a formed configuration.
19. The end effector of claim 18, wherein the first end of the
cartridge is movably coupled to the first end of the anvil and the
second end of the cartridge is movably coupled to the second end of
the anvil.
20. The end effector of claim 18, wherein a portion of the anvil
face is angled relative to a portion of the cartridge face.
21. The end effector of claim 18, wherein the first staple has a
substantially pretzel-shaped configuration.
22. The end effector of claim 18, wherein the first staple pocket
is operably configured to deform the first staple such that the
first tip and the second tip pass over the midline axis of the
crown when deployed.
23. The end effector of claim 18, wherein the anvil face has a
stepped configuration including a first segment and a second
segment that are offset.
24. The end effector of claim 18, wherein the first staple
formation distance is provided at a proximal end of the end
effector and the second staple formation distance is provided at a
distal end of the end effector.
25. The end effector of claim 18, wherein the first staple
formation distance corresponds with a first longitudinal row of
staple pockets and drivers and the second staple formation distance
corresponds with a second longitudinal row of staple pockets and
drivers.
26. The end effector of claim 25, wherein the first longitudinal
row of staple pockets and drivers is an outer row and the second
longitudinal row of staple pockets and drivers is an inner row.
27. The end effector of claim 18, wherein the first staple
formation distance is greater than the second staple formation
distance.
28. The end effector of claim 18, wherein the first open leg and
the second open leg have different lengths.
29. The end effector of claim 18, further comprising a first wedge
operably configured to actuate the first driver and a second wedge
operably configured to actuate the second driver, wherein the first
wedge and the second wedge have the same configuration.
30. The end effector of claim 18, wherein the first staple
formation distance corresponds with a first lateral row of staple
pockets and drivers and the second staple formation distance
corresponds with a second lateral row of staple pockets and
drivers.
Description
REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. Non-Provisional
application Ser. No. 16/538,480, filed Aug. 12, 2019, which is a
continuation of U.S. Non-Provisional application Ser. No.
15/633,399, filed Jun. 26, 2017, which is a continuation of U.S.
Non-Provisional application Ser. No. 15/129,366, filed Sep. 26,
2016, now U.S. Pat. No. 9,724,096, which was a National Stage
Application under 35 U.S.C. .sctn. 371 of PCT International
Application No. PCT/US2015/022990, filed Mar. 27, 2015, which
claims the priority benefit of U.S. Provisional Patent App. No.
61/972,274 filed Mar. 29, 2014, and U.S. Provisional Patent App.
No. 62/046,726 filed Sep. 5, 2014, each of which is incorporated
herein by reference in its entirety.
TECHNICAL FIELD
[0002] The invention relates to surgical staplers, and more
particularly to end effectors and stapling devices and methods of
using those devices in medical procedures.
BACKGROUND
[0003] Obesity, as a disease, affects a significant portion of the
world's population. Obesity often leads to multiple chronic medical
conditions and premature death from cardiovascular events and
cancer. The U.S. Centers for Disease Control and Prevention ("CDC")
reports that over 33% of the U.S. population is obese, with a body
mass index ("BMI") of over 30, and another 35-40% of the population
is overweight, with a BMI of 2530. The CDC reports that the percent
of the population being either overweight or obese by 2018 will be
75%. The CDC also reports that obesity directly costs the U.S.
economy $147 billion currently, and projects that the costs will
approach $315 billion by 2020. The increase in obesity and the
financial impact on the local economy is not limited to the United
States but impacts many countries throughout the world.
[0004] Obesity has environmental, genetic, and behavioral origins
but is intractable to most medical and behavioral interventions.
Weight loss, or bariatric, surgery seems to be the only effective
long-term treatment option for patients with a BMI greater than 35.
Despite the 20 million patients who are eligible for weight loss
surgery in the United States, the number of procedures per year has
plateaued at about 200,000, essentially eliminating any meaningful
public health effect of the surgery.
[0005] In recent years, laparoscopic vertical sleeve gastrectomy
has emerged as a procedure that is safe and effective for patients
who are eligible for weight loss surgery. Laparoscopic surgery is a
form of minimally invasive surgery inside of the abdominal cavity
performed at a distance by the surgeon. Laparoscopic surgery
instrumentation is designed to fit through small incisions in the
abdominal wall, typically 5 mm to 15 mm in diameter. The abdominal
access sites are maintained by cannulae, or trocars, that are
designed to maintain pressure in the abdominal cavity with valves
that seal around an instrument shaft. Videoscopic guidance may be
used throughout the surgery. Since its introduction in 2003 as a
stand-alone surgery, vertical sleeve gastrectomy has been studied
extensively. It is now widely accepted as the surgery that should
be offered to most morbidly obese patients over laparoscopic
adjustable gastric banding and laparoscopic Roux-en-Y gastric
bypass. The surgery has been adopted by most bariatric surgeons and
is now one of the most commonly used procedures to achieve
effective weight loss.
[0006] During a vertical sleeve gastrectomy, approximately 80% of
the stomach is removed and the remaining pouch is based on the less
distensible lesser curve of the stomach. The fundus of the stomach,
which is formed by the upper curvature of the organ, is the most
crucial portion of the stomach that is removed. The resultant
gastric pouch generally should be about 80 mL to about 820 mL in
volume, should not be narrowed at the incisura angularis, should be
as straight as possible to avoid obstruction from spiraling or
zigzagging, should be about 0.5 cm to about 2 cm away from the
gastro esophageal junction, and should be about 2 cm to about 10 cm
away from the pylorus.
[0007] A vertical sleeve gastrectomy is typically performed using
standard laparoscopic equipment. The greater curvature of the
stomach is mobilized by using vessel-sealing devices to seal the
gastric branches of the gastro epiploic vessels and the short
gastric vessels. The posterior adhesions of the stomach are also
divided so the stomach is fully mobilized while the blood supply to
the lesser curvature remains intact. The left crus of the diaphragm
is an important landmark to ensure the fundus has been fully
mobilized.
[0008] Following mobilization of the stomach and repair of any
hiatal hernia that may be present, a calibration tube or bougie is
typically introduced into the stomach through the mouth. The bougie
is inserted through the mouth, down the esophagus, and into the
stomach, where it is used as a point of reference in order to help
align the initial staple fire. The bougie acts as a left-hand
landmark, which the surgeon uses to visualize the path of the
staple line. A surgeon creating a sleeve gastrectomy staple line
will estimate 2.0 cm away from the lesser curvature of the stomach
and visually orient the stapler. As constant diameter bougies
cannot be used to facilitate orienting the stapler, only surgeon
experience and estimation is used. At the top of the staple line,
it is important to not divide part of the esophagus or the `sling
fibers` of the cardia, which participate in the physiologic
anti-reflux action of the lower esophageal sphincter. Surgeons must
use visual cues to ensure that the staple line is a safe distance
away from the gastro esophageal junction.
[0009] Resection is accomplished by a series of applications of a
laparoscopic linear surgical stapler, which are also referred to as
endocutter surgical staplers. The staplers that are most commonly
used for sleeve gastrectomy are no more than 60 mm in length and
include an integrated cutting blade, an anvil, and a cartridge,
where the anvil and cartridge are parallel in the longitudinal
direction. Conventional endocutter staplers have double or triple
staggered rows of staples on either side of the cutting blade. Each
staple application places two or three staggered rows of staples
into the tissue on either side of the cutting blade. For sleeve
gastrectomy, the average number of staple fires per procedure is 3
to 7 in order to create a continuous resection line. This results
in a resection line that is about 15 cm to about 37 cm on
average.
[0010] Proper alignment between the anvil and cartridge is very
important during staple formation. Surgical staplers must have
alignment in the x, y, and z axes to be able to form B-shaped
staples. The alignment of the anvil and cartridge must be
maintained along the length of the stapler. The anvil may be
deflected during staple formation due at least in part to the
forces of tissue and staple formation on the anvil. This deflection
has limited the lengths of staplers. More specifically, the longer
the stapler is, the more the tip of the stapler tends to deflect.
This often results in a gap that is too wide to form staples
appropriate for the thickness of the tissue to be stapled.
[0011] Currently, surgeon training, experience, and trial and error
are the only tools used to aid the surgeon in determining the path
of the resection line in a vertical sleeve gastrectomy. Only after
applying the stapler to begin creating the resection line is the
resultant stomach anatomy demonstrated. Before beginning stapling,
the surgeon must attempt to envision the resultant anatomy of the
stomach. Further, the surgeon must actively and accurately control
the stapler during the resection to produce the desired resection
line. Because the thickness of the stomach tissue varies at the
antrum, the body, and the fundus, different staple leg lengths are
typically used. This requires the stapler to be removed from the
patient between firings to load the stapler with a new cartridge
having staples with an appropriate leg length. Generally, one or
more applications of cartridges including staples with a longer
closed leg length are followed by one or more applications of
cartridges including staples with a shorter closed leg length. This
serial cartridge application can lead to a less than optimal
anatomic appearance of the segmented staple line, such as a
"zig-zagging" or spiraling line.
[0012] There is wide variability in the size and type of
calibration tube, or bougie, used by surgeons to size the remaining
gastric sleeve. Some surgeons use an endoscope (30 French or 1 cm
in diameter) while others use a large mercury-weighted bougie (60
French or 2 cm in diameter). In a large meta-analysis, there was no
difference in weight loss when bougie sizes of less than 40 and
greater than 40 were used. The resection line is important in
sleeve gastrectomy because the amount of weight loss and subsequent
medical complications may be a direct result of the quality of the
resultant anatomy. The resultant anatomy is determined by the
staple line created by the surgeon during the gastrectomy. Negative
consequences related to the quality of the staple line may include,
for example, gastro esophageal reflux, weight loss failure, weight
regain, food intolerance, resection line bleed, and leak.
[0013] Leaks are the most concerning complication of a vertical
sleeve gastrectomy. In large pooled databases, the leak rate is
approximately 0.3 to 2%. Leak is thought to be prevented by making
a straight staple line that avoids crossing cartridge applications,
has no narrow segments (particularly at the incisura angularis), is
about 1 cm from the gastro esophageal junction, and has a
squared-off final application. Generally speaking, leak is not
prevented by sewing over the staple line or using staple line
buttress material in the resection line. Leak is thought to be more
a result of poor resultant stomach anatomy. Poor anatomy is a
direct result of the shortcomings of the calibration equipment and
technique used to create the staple line. Conventional calibration
tubes specifically designed for use in a sleeve gastrectomy may
provide some user benefits, but fail to reliably produce the proper
geometry of the resultant anatomy from the vertical sleeve
gastrectomy.
[0014] Accordingly, new apparatuses and methods are needed to
address the shortcomings of existing apparatuses and methods. More
particularly, improved apparatuses and methods are needed that
improve the consistency and quality of the staple line created
during a medical procedure, such as a vertical sleeve
gastrectomy.
[0015] Summar
[0016] An end effector for use by a surgeon to staple an anatomical
structure of a patient during a surgical procedure addresses these
and other shortcomings and, in one embodiment, the anatomical
structure has a first side and a second side and the end effector
includes an anvil that includes a first end, a second end, and a
face that is positionable on the first side of the anatomical
structure. The end effector further includes a cartridge that is
configured to house a plurality of staples and that includes a
first end, a second end, and a face that is positionable on the
second side of the anatomical structure. The first end of the
cartridge is movably coupled to the first end of the anvil, and the
second end of the cartridge is movably coupled to the second end of
the anvil. The anvil is movable relative to the cartridge to define
a first gap between the faces at the first ends that is less than a
second gap between the faces at the second ends.
[0017] In one embodiment, the decrease from the first gap to the
second gap is determined by an angle of from about 0.1.degree. to
about 1.degree..
[0018] In one embodiment, the first gap is from about 1.5 mm to
about 3.3 mm.
[0019] In one embodiment, the second gap is from about 2.0 mm to
about 5.0 mm.
[0020] In one embodiment, the first ends define a distal end of the
end effector and the second ends define a proximal end of the end
effector.
[0021] In one embodiment, the end effector further includes a shim
having a wedge-shape coupled to the face of at least one of the
anvil and the cartridge and defining at least one of the first gap
and the second gap.
[0022] In one embodiment, each face defines a width and the shim
extends the width of at least one of the faces.
[0023] In one embodiment, a thickness of the shim varies across a
width of the shim.
[0024] In one embodiment, the end effector further includes a shim
having a wedge-shape coupled to the face of at least one of the
anvil and the cartridge and defining each of the first gap and the
second gap.
[0025] In one embodiment, the end effector further includes a shim
that is coupled to the face of at least one of the anvil and the
cartridge, the shim having a first end, a second end, and a
thickness, the thickness of the shim at the first end being
different than the thickness of the shim at the second end.
[0026] In one embodiment, at least one of the faces of the anvil
and the cartridge has a stepped configuration including at least
two segments that are offset from one another. One segment defines
the first gap and the other segment defines the second gap.
[0027] In one embodiment, the cartridge includes a plurality of
staples and an open leg length of each of the staples in each
segment is the same.
[0028] In one embodiment, the cartridge includes staples each
having an open leg length and the open leg length of one staple in
one segment is different from the open leg length of one staple in
the other segment.
[0029] In one embodiment, the cartridge includes a plurality of
staple drivers each having a height and the height of at least two
staple drivers are different in a direction from the first end to
the second end of the cartridge.
[0030] In one embodiment, the cartridge includes staples, each
staple having an open leg length, the open leg length of at least
one staple is different from the open leg length of another staple
along a length of the cartridge from the first end to the second
end.
[0031] In one embodiment, the open leg lengths of the staples are
randomly distributed.
[0032] In one embodiment, a distribution of the open leg lengths of
the staples is based on a probable tissue thickness along the
anatomical structure from the first end to the second end.
[0033] In one embodiment, the staples are divided into at least two
zones of staples. The staples are arranged in at least one row and
at least one column in each zone. The open leg length of one staple
in one zone differs from the open leg length of another staple in
the other zone.
[0034] In one embodiment, the cartridge has a first edge and a
second edge and one staple in the zone adjacent the first edge has
a greater open leg length than another staple in the zone adjacent
the second edge.
[0035] In one embodiment, the cartridge includes a plurality of
staples divided into at least two zones, and a crown length of one
staple in one zone differs from a crown length of another staple in
the other zone.
[0036] In one embodiment, the cartridge includes a plurality of
staples divided into at least two zones of staples, and a gauge of
one staple in one zone differs from a gauge of another staple in
the other zone.
[0037] In one embodiment, the cartridge includes a plurality of
magazines configured to be selectively inserted and removed from
the cartridge, each magazine including a plurality of staples
arranged in one or more rows and one or more columns.
[0038] In one embodiment, a length of at least one magazine is from
about 5 mm to about 250 mm.
[0039] In one embodiment, at least one magazine includes a channel
for a cutting blade with at least one column of staples on each
side of the channel.
[0040] In one embodiment, the magazines include an interlock
feature.
[0041] In one embodiment, the interlock feature includes a
projection on one of the magazines and a recess on another of the
magazines, the projection being configured to be received in the
recess when the magazines are adjacent to each other in the
cartridge.
[0042] In one embodiment, the cartridge includes a plurality of
staples arranged in rows and columns, each staple having an open
leg length, the staples in each column having about the same open
leg length. Each of the anvil and the cartridge has a first edge
and a second edge, the anvil being movable relative to the
cartridge to define a first edge gap between the faces at the first
edges that is less than a second edge gap between the faces at the
second edges.
[0043] In one embodiment, the end effector further includes an
alignment mechanism configured to facilitate alignment between the
anvil and the cartridge as the anvil is moved toward the
cartridge.
[0044] In one embodiment, the alignment mechanism includes a knife
that is partially housed in the cartridge and that has a first
flange, a second flange, and a web connecting the first and second
flanges and including a cutting edge. The alignment mechanism
further includes a recess in the anvil face that is configured to
receive the first flange. The alignment mechanism further includes
a first slot in the anvil that is open to the anvil face and to the
recess and that is configured to slidably receive the web during
cutting of the anatomical structure with the cutting edge and a
second slot in the cartridge that is open to the cartridge face and
that is configured to slidably receive the web during cutting of
the anatomical structure.
[0045] In one embodiment, the anvil has a first guide channel open
to the first slot, the cartridge has a guide channel open to the
second slot, and the first and second guide channels are
parallel.
[0046] In one embodiment, the anvil face and the cartridge face are
not parallel.
[0047] In one embodiment, at least one of the anvil face and the
cartridge face has a stepped configuration including at least two
segments that are offset from one another, one segment defines the
first gap and the other segment defines the second gap.
[0048] In one embodiment, one of the first and second flanges has a
V-shaped cross-section.
[0049] In one embodiment, the staples have two legs and a crown
having a midline and the staple pockets are configured to bend the
two legs past the midline of the crown when the end effector is
actuated.
[0050] In one embodiment, each of the anvil and the cartridge has a
first edge and the end effector further includes a spacer coupled
to the first edge of at least one of the anvil and the cartridge
and being configured to abut an anatomical feature to space the end
effector apart from the anatomical feature by a known distance.
[0051] In one embodiment, the end effector is insertable through a
trocar.
[0052] In one embodiment, the end effector further includes a
flexible member that movably couples the first end of the anvil to
the first end of the cartridge.
[0053] In one embodiment, at least one of the anvil and the
cartridge slidably receives the flexible member when the end
effector is clamped on to the anatomical structure.
[0054] In one embodiment, the flexible member is anchored to the
anvil.
[0055] In one embodiment, the flexible member is anchored to the
cartridge.
[0056] In one embodiment, the end effector further includes a
tensioning device operable by the surgeon for selectively
tensioning the flexible member to provide at least a portion of the
clamping force on the anatomical structure.
[0057] In one embodiment, each of the anvil and the cartridge is
insertable through a trocar and the end effector is remotely
operable from outside the patient to clamp the end effector to the
anatomical structure according to the first gap and the second
gap
[0058] A stapling device for use by a surgeon to staple an
anatomical structure of a patient during a surgical procedure, in
one embodiment, the anatomical structure has a first side and a
second side and the endocutter stapling device includes an end
effector and a manipulator that is configured to be accessible to
the surgeon outside of the patient and that includes a shaft
coupled to the end effector and a clamping mechanism for
selectively moving the anvil and the cartridge toward one another
to clamp the anatomical structure. The device further includes a
flexible member that extends through the shaft to the end effector
and is operably coupled to at least one of the anvil and the
cartridge and to the clamping mechanism such that operating the
clamping mechanism withdraws the flexible member from the end
effector and clamps the anatomical structure between the anvil and
the cartridge.
[0059] In one embodiment, the clamping mechanism is capable of
selectively tensioning the flexible member to clamp the anvil and
the cartridge to the anatomical structure with a first stage
clamping force that permits the end effector to be repositioned
relative to the anatomical structure.
[0060] In one embodiment, the first stage clamping force is between
about 0.1 g/mm2 and about 4 g/mm2.
[0061] In one embodiment, the clamping mechanism is capable of
selectively tensioning the flexible member to clamp the anvil and
the cartridge to the anatomical structure with a second stage
clamping force that substantially prevents the end effector from
moving relative to the anatomical structure during the medical
procedure.
[0062] In one embodiment, the second stage clamping force is
between about 4 g/mm2 and about 70 g/mm2.
[0063] In one embodiment, the manipulator includes a handpiece that
at least partially houses the clamping mechanism, the clamping
mechanism further includes a lever that is pivotable relative to
the handpiece and is operable to activate the clamping
mechanism.
[0064] In one embodiment, the clamping mechanism includes a first
push bar that is pivotably coupled to the lever, a second push bar
that is pivotably coupled to the first push bar, and a pin that is
coupled to the second push bar, the flexible member extending
around the pin. Rotation of the lever relative to the handpiece
moves the pin and withdraws the flexible member from the end
effector
[0065] In one embodiment, the manipulator includes a stapling
mechanism that has an actuator coupled to an actuator plate that is
slidable relative to the end effector and at least one wedge
coupled to the actuator plate. Activating the actuator slides the
actuator plate and the at least one wedge in the direction of the
end effector to force the wedge into engagement with staples.
[0066] In one embodiment, the actuator is a thumb plate.
[0067] In one embodiment, the manipulator includes a cutting
mechanism that is configured to cut the anatomical structure and is
coupled to the actuator plate and, when the actuator is engaged,
the stapling mechanism begins stapling the anatomical structure
prior the cutting mechanism cutting the anatomical structure.
[0068] An end effector for use by a surgeon to staple an anatomical
structure of a patient during a surgical procedure, in one
embodiment, the anatomical structure has a first side and a second
side and the end effector includes an anvil that includes a first
end, a second end, a face that is positionable on the first side of
the anatomical structure, and a first edge. The end effector
further includes a cartridge that is configured to house a
plurality of staples and that includes a first end, a second end, a
face that is positionable on the second side of the anatomical
structure, and a first edge. The first end of the cartridge is
movably coupled to the first end of the anvil. The end effector
further includes a spacer configured to be coupled to the first
edge of at least one of the anvil and the cartridge.
[0069] An end effector for use by a surgeon to staple an anatomical
structure of a patient during a surgical procedure, in one
embodiment, the anatomical structure having a first side and a
second side and the end effector includes an anvil that includes a
first end, a second end, a face that is positionable on the first
side of the anatomical structure, the face defining a width, a
first edge, and a second edge. The end effector further includes a
cartridge that includes a plurality of staples arranged in rows and
columns, each staple having an open leg length, the staples in each
column having about the same open leg length, a first end, a second
end, and a face that is positionable on the second side of the
anatomical structure, the face defining a first edge, a second
edge, and a width between the first edge and the second edge. The
first end of the cartridge is movably coupled to the first end of
the anvil, the anvil being movable relative to the cartridge to
define a first edge gap between the faces at the first edges that
is less than a second edge gap between the faces at the second
edges. When the end effector is positioned on the anatomical
structure, the first edge gap linearly increases to the second edge
gap.
[0070] An end effector for use by a surgeon to staple an anatomical
structure of a patient during a surgical procedure, in one
embodiment, the anatomical structure having a first side and a
second side and the end effector includes an anvil that includes a
first end, a second end, a face that is positionable on the first
side of the anatomical structure, the face defining a width, and a
first edge. The end effector further includes a cartridge that is
configured to house a plurality of staples and that includes a
first end, a second end, a face that is positionable on the second
side of the anatomical structure, the face defining a width, and a
first edge. The first end of the cartridge is movably coupled to
the first end of the anvil. The end effector further includes a
shim that is coupled to the face of at least one of the anvil and
the cartridge, the shim having a first edge, a second edge, and a
thickness, the thickness of the shim at the first edge being
different than the thickness of the shim at the second edge.
[0071] In one embodiment, the shim extends the width of at least
one of the faces.
[0072] In one embodiment, a thickness of the shim varies across the
width of the shim.
[0073] An end effector for use by a surgeon to staple an anatomical
structure of a patient during a surgical procedure, in one
embodiment, the anatomical structure has a first side and a second
side and the end effector includes an anvil that includes a first
end, a second end, a face that is positionable on the first side of
the anatomical structure. The end effector further includes a
cartridge that includes a plurality of staple channels arranged in
one or more rows and one or more columns, is configured to house a
plurality of staples individually in the staple channels, and that
includes a first end, a second end, and a face that is positionable
on the second side of the anatomical structure, the rows extending
from the first end toward the second end. The first end of the
cartridge is movably coupled to the first end of the anvil. The end
effector further includes a shim that is coupled to the face of at
least one of the anvil and the cartridge, the shim covering less
than all of the rows of the staple channels.
[0074] A cartridge for use in an end effector having an anvil, the
end effector being for use by a surgeon to staple an anatomical
structure of a patient during a surgical procedure, in one
embodiment, the anatomical structure has a first side and a second
side and the cartridge includes a cartridge body defining a
plurality of staple channels. The cartridge further includes a
plurality of staples arranged in rows and columns, each staple
having an open leg length and a crown and being housed in one of
the staple channels. The open leg length of one of the staples
differs from the open leg length of another of the staples in a
longitudinal direction along the rows. The open leg length of the
staples is selected based on a probable tissue thickness along the
anatomical structure from the first end to the second end.
[0075] In one embodiment, the cartridge body is divided into at
least two zones, each zone having a plurality of staples arranged
in at least one row and at least one column, each staple having an
open leg length. The open leg length of one staple in one zone
differs from the open leg length of one staple in the other
zone.
[0076] In one embodiment, the cartridge includes a plurality of
magazines configured to be selectively inserted and removed from
the cartridge, each magazine including a plurality of staples
arranged in one or more rows and one or more columns.
[0077] In one embodiment, a length of at least one magazine is from
about 5 mm to about 250 mm.
[0078] In one embodiment, at least one magazine includes a channel
for a cutting blade with at least one column of staples on each
side of the channel.
[0079] In one embodiment, the magazines include an interlock
feature.
[0080] In one embodiment, the interlock feature includes a
projection on one of the magazines and a recess on another of the
magazines, the projection being configured to be received in the
recess when the magazines are adjacent to each other in the
cartridge.
[0081] A method of stapling an anatomical structure during a
surgical medical procedure, in one embodiment, includes
[0082] In one embodiment, inserting the end effector of claim 1
through a trocar into a patient adjacent the anatomical structure,
the cartridge including a plurality of staples, positioning the
anvil and the cartridge on opposing sides of the anatomical
structure, clamping the end effector to the anatomical structure at
the first ends of the anvil and the cartridge and the second ends
of the anvil and the cartridge to secure the position of the end
effector relative to the anatomical structure, and actuating the
end effector to staple the anatomical structure.
[0083] In one embodiment, the method further includes positioning a
clamp adjacent to the anatomical structure, and wherein positioning
the anvil and the cartridge includes positioning at least one of
the anvil and cartridge adjacent the clamp.
[0084] In one embodiment, the staples having an open leg length are
arranged in rows and columns and the open leg length of each of the
staples is the same in each column, and actuating the end effector
includes forming a first row of staples and a second row of
staples, the staples in the first row having a greater closed leg
length than the staples in the second row
[0085] In one embodiment, each of the anvil and the cartridge have
a first edge and a second edge and clamping the end effector to the
anatomical structure includes compressing the anatomical structure
more at the first edges than at the second edges.
BRIEF DESCRIPTION OF THE DRAWINGS
[0086] The accompanying drawings, which are incorporated in and
constitute a part of this specification, illustrate embodiments of
the invention and, together with a general description of the
invention given above, and the detailed description given below,
serve to explain the invention.
[0087] FIG. 1 depicts the anatomy of a stomach.
[0088] FIG. 2A is an elevation view of an end effector of an
endocutter stapling device according to one embodiment of the
invention.
[0089] FIG. 2B is an elevation view of the end effector of FIG. 2A
positioned on the stomach.
[0090] FIG. 2C is an elevation view of the end effector of FIG. 2A
during resection of a portion of the stomach.
[0091] FIG. 2D is an elevation view of the end effector of FIG. 2A
following resection of a portion of the stomach.
[0092] FIG. 2E depicts the stomach anatomy resulting from a
vertical sleeve gastrectomy.
[0093] FIG. 3 is a perspective view of an endocutter stapling
device according to one embodiment of the invention.
[0094] FIG. 4 is a perspective view of the endocutter stapling
device of FIG. 3 with an end effector shown in an opened
position.
[0095] FIG. 4A is an enlarged perspective view of the end effector
shown in FIG. 4.
[0096] FIG. 5 is a disassembled perspective view of the endocutter
stapling device of FIG. 3.
[0097] FIG. 6 is a cross-sectional view of the endocutter stapling
device taken along section line 6-6 of FIG. 4.
[0098] FIG. 6A is a cross-sectional view of the end effector shown
in FIG. 4A taken along section line 6A-6A.
[0099] FIG. 7 is a cross-sectional view of the endocutter stapling
device taken along section line 7-7 of FIG. 3.
[0100] FIG. 7A is a cross-sectional view of the endocutter stapling
device taken along section line 7A-7A in FIG. 7.
[0101] FIG. 8 is an enlarged perspective view of a handpiece of the
endocutter stapling device of FIG. 3.
[0102] FIG. 9 is an enlarged view of the encircled area 9 shown in
FIG. 8.
[0103] FIG. 10 is an enlarged view of the encircled area of the
endocutter stapling device of FIG. 7.
[0104] FIG. 10A is a cross-sectional view of the endocutter
stapling device taken along section line 10A-10A in FIG. 10.
[0105] FIG. 10B is an enlarged view of the endocutter stapling
device similar to FIG. 10 during use of the endocutter stapling
device.
[0106] FIG. 10C is a perspective view of a knife and a pair of
wedges of the endocutter stapling device of FIG. 3.
[0107] FIG. 10D is a perspective view of the knife and the pair of
wedges shown in FIG. 10 during use of the endocutter stapling
device.
[0108] FIG. 11 is a schematic elevation view of an end effector
according to one embodiment of the present invention.
[0109] FIG. 12A is a schematic elevation view of an end effector
according to one embodiment of the present invention.
[0110] FIG. 12B is a schematic elevation view of the end effector
of FIG. 12A positioned on a stomach after actuation of an
endocutter stapling device according to one embodiment of the
invention to complete a staple line.
[0111] FIG. 12C is a schematic elevation view of stomach anatomy
resulting from the use of an endocutter stapling device according
to one embodiment of the invention.
[0112] FIG. 13 is a perspective view of a shim according to one
embodiment of the present invention.
[0113] FIG. 14A is a schematic elevation view of an end effector
according to one embodiment of the present invention.
[0114] FIG. 14B is a schematic elevation view of the end effector
of FIG. 14A positioned on a stomach after actuation of an
endocutter stapling device according to one embodiment of the
invention to complete a staple line.
[0115] FIG. 15A is a schematic elevation view of an end effector
according to one embodiment of the present invention.
[0116] FIG. 15B is a schematic elevation view of the end effector
of FIG. 15A positioned on a stomach after actuation of an
endocutter stapling device according to one embodiment of the
invention to complete a staple line.
[0117] FIG. 16A is a schematic elevation view of an end effector
according to one embodiment of the present invention.
[0118] FIG. 16B is a schematic elevation view of the end effector
of FIG. 16A positioned on a stomach after actuation of an
endocutter stapling device according to one embodiment of the
invention to complete a staple line.
[0119] FIG. 17A is a schematic elevation view of an end effector
according to one embodiment of the present invention.
[0120] FIG. 17B is a schematic elevation view of the end effector
of FIG. 17A positioned on a stomach after actuation of an
endocutter stapling device according to one embodiment of the
invention to complete a staple line.
[0121] FIG. 18 is a schematic elevation view of an end effector
according to one embodiment of the present invention.
[0122] FIG. 19 is a schematic elevation view of a cartridge
according to one embodiment of the present invention.
[0123] FIG. 20A is a schematic elevation view of an end effector
including the cartridge of FIG. 19.
[0124] FIG. 20B is a schematic elevation view of the end effector
of FIG. 20A during compression of the stomach.
[0125] FIG. 20C is a schematic elevation view of the end effector
of FIG. 20A following stapling of the stomach.
[0126] FIG. 21 is a schematic elevation view of a cartridge
according to one embodiment of the present invention.
[0127] FIG. 22 is a schematic elevation view of a cartridge
according to one embodiment of the present invention.
[0128] FIG. 23 is a schematic elevation view of a cartridge
according to one embodiment of the present invention.
[0129] FIGS. 23A and 23B are cross-sectional views of the cartridge
of FIG. 23 taken along section line 23A-23A and 23B-23B,
respectively.
[0130] FIG. 23C is a perspective view of an arrangement of staples
in a cartridge according to one embodiment of the invention.
[0131] FIG. 24A is a plan view of a cartridge according to one
embodiment of the present invention.
[0132] FIG. 24B is an enlarged perspective view of a magazine of
FIG. 24A illustrating the assembly of the cartridge.
[0133] FIG. 24C is an enlarged perspective view of a portion of the
cartridge of FIG. 24A following assembly according to FIG. 24B.
[0134] FIG. 25 is a plan view of a cartridge according to one
embodiment of the present invention.
[0135] FIG. 26A is a cross-sectional view of an end effector
according to one embodiment of the invention taken along section
line 26A-26A of FIG. 25.
[0136] FIG. 26B is a cross-sectional view of an alternative
cartridge according to one embodiment of the invention similar to
that shown in FIG. 26A.
[0137] FIGS. 27A and 27B are cross-sectional views of an end
effector according to one embodiment of the invention before and
after stapling, respectively.
[0138] FIG. 27C is a cross-sectional view of the staple line after
actuation of an endocutter stapling device according to one
embodiment of the invention to complete a staple line.
[0139] FIG. 28A is a cross-sectional view of an end effector
according to one embodiment of the present invention.
[0140] FIG. 28B is a cross-sectional view of the staple line after
actuation of the end effector shown in FIG. 28A according to one
embodiment of the invention to complete a staple line.
[0141] FIG. 29 is a plan view of a cartridge according to one
embodiment of the invention.
[0142] FIG. 30A is a cross-sectional view of an end effector
including a cartridge shown in FIG. 29 taken along section line
30A-30A.
[0143] FIG. 30B is a cross-sectional view of an end effector
similar to that of FIG. 30A according to one embodiment of the
present invention.
[0144] FIG. 30C is a cross-sectional view of the end effector of
FIG. 30B during stapling of a stomach according to one embodiment
of the invention.
[0145] FIGS. 31 and 32 are cross-sectional views of end effectors
according to embodiments of the present invention.
[0146] FIGS. 33-36 are elevation views of end effectors according
to various embodiments of the present invention.
[0147] FIGS. 37A and 37B are an elevation view and a plan view,
respectively, of a staple according to one embodiment of the
present invention.
[0148] FIGS. 38A and 38B are an elevation view and a plan view,
respectively, of a staple according to one embodiment of the
present invention.
[0149] FIGS. 39A and 39B are a cross-sectional view and a plan
view, respectively, of a staple pocket according to one embodiment
of the present invention.
[0150] FIGS. 40A and 40B are a cross-sectional view and a plan
view, respectively, of a staple pocket according to one embodiment
of the present invention.
[0151] FIG. 41 is an elevation view of one embodiment of the
present invention following resection of a stomach.
[0152] FIG. 42 is a perspective view of an end effector according
to one embodiment of the invention positioned on a stomach.
DETAILED DESCRIPTION
[0153] In its broadest aspects, embodiments of the present
invention are directed to a stapler for creating a staple line
during a surgical procedure involving the resection of at least a
part of an anatomical structure. For example, the stapler may be
used in a vertical sleeve gastrectomy procedure. The stapler may be
a supplement to current practices of a sleeve gastrectomy,
including the laparoscopic access and mobilization of the greater
curvature of the stomach. As is described in detail below,
embodiments of the stapler account for variations in thickness of
the tissue and, in doing so, are believed to provide a staple line
of improved integrity.
[0154] While embodiments discussed below involve the use of a
stapler to create a staple line during a medical procedure, it
should be recognized that the stapler may act as a surgical clamp
independent of its use as stapler. Further, while embodiments
discussed below involve the use of the stapler in a vertical sleeve
gastrectomy procedure, the stapler may also be adapted for use in
other procedures involving anatomical structures, such as organs
other than the stomach or soft tissue. For example, the stapler may
be used in a parencymal resection, lung volume reduction surgery,
or other procedures involving the lung. Further, the stapler may be
useful in an anatomic resection such as a lobectomy, a non-anatomic
parencymal resection, or other procedures involving the liver.
Moreover, a surgeon or other medical professional may benefit from
using the stapler in a partial nephrectomy, total nephrectomy, or
other procedures involving the kidney. During procedures involving
an anatomical structure, the tissue of the anatomical structure may
be sealed. Thus, while aspects of the present invention may be
illustrated in the context of a vertical sleeve gastrectomy, it
should be appreciated that aspects of the invention may provide a
benefit in a host of medical procedures on anatomical structures
and be adapted for use in such medical procedures.
[0155] Now referring to the figures, FIG. 1 illustrates the anatomy
of a stomach 10 and a staple line 12, where the staple line 12
represents a resection line for a vertical sleeve gastrectomy. The
stomach 10 generally includes a proximal end 14, a distal end 16,
an anterior side 18, and a posterior side 20. As used herein, the
proximal and distal ends 14, 16 of the stomach 10 are described
from the perspective of the operative surgeon. A gastro esophageal
junction 22 opens into the stomach 10 and is a common landmark in
bariatric surgeries. An antrum 24 and a fundus 26 are located
adjacent the proximal and distal ends 14, 16 of the stomach 10,
respectively. The thickness of the stomach 10 generally increases
from the fundus 26 to the antrum 24. The thickness of the stomach
may also vary based on other factors. For example, male stomachs
tend to have a greater thickness than female stomachs. Further,
patients with a higher body mass index ("BMI") tend to have
stomachs with a greater thickness than stomachs of patients with a
lower BMI. The staple line 12 therefore traverses the stomach 10
over a portion in which the thickness of the tissue changes. The
fundus 26 and the section of the stomach 10 defined by the greater
curvature 28 are generally the parts of the stomach 10 removed
during a vertical sleeve gastrectomy. The desired location of the
staple line 12 is about 0.5 cm to about 2 cm away from the gastro
esophageal junction 22 and about 2 cm to about 10 cm away from the
pylorus 32.
[0156] Following the gastrectomy, the remaining pouch is generally
defined by a lesser curvature 30 and the staple line 12 and
presents a stomach with a significantly reduced volume. In
accordance with aspects of the invention, staplers as described
herein aid in forming high quality, consistent staple lines during
a medical procedure, such as a vertical sleeve gastrectomy. In this
regard, the staplers provide an accurate visual indication of the
staple line before the stapler has been actuated. The visualization
aspect of the disclosed staplers is believed to result in high
quality and consistent staple lines that are significantly improved
over staple lines produced by current methodologies. Furthermore,
unlike the prior art, embodiments of the stapler account for tissue
thickness variation, such as, thickness variations associated with
the staple line 12, during clamping and/or stapling which is also
believed to result in high quality and consistent staple lines.
[0157] To these and other ends, and with reference to FIG. 2A,
embodiments of the present invention may include an end effector 40
having an anvil 42 and a cartridge 44 coupled to one another. As is
described below in reference to FIGS. 2B-2E, the surgeon may
forcibly drive the anvil 42 and the cartridge 44 toward one another
to clamp the stomach 10 between the anvil 42 and the cartridge 44.
The surgeon may close the anvil 42 and the cartridge 44 remotely
from the end effector 40. That is, no direct manual access to the
end effector 40 is required. For this reason, the end effectors, as
disclosed herein, may be designed specifically for use in surgical
procedures in which the organ is accessed through a trocar.
[0158] According to one aspect, clamping onto the stomach 10
permits the surgeon to be able to accurately position the end
effector 40 and ensures creation of a straight sleeve gastrectomy
pouch. In the exemplary embodiment, and with reference to FIG. 2B,
the anvil 42 may be generally positionable on the anterior side 18
of the stomach 10, and the cartridge 44 may be generally
positionable on the posterior side 20 of the stomach 10. The
cartridge 44 may house a plurality of surgical staples and a knife,
each described below, for forming the staple line 12. The anvil 42
and the cartridge 44 may be coupled together via a flexible member
46 and collectively operate as clamping members for purposes
described below. The present invention is not limited to the
illustrated arrangement. For example, the arrangement of the anvil
42 and the cartridge 44 may be reversed such that the anvil 42 is
coupled to a shaft and is positioned adjacent the posterior side 20
of the stomach 10 and the cartridge 44 is coupled to the anvil 42
via the flexible member 46 and is positioned on the anterior side
18 of the stomach 10 (not shown). Other alternative arrangements
may also be possible depending on the surgical procedure and the
surgeon's preference, among other factors. There are many ways to
couple the anvil 42 and the cartridge 44 and the invention is not
limited to the flexible member shown. By way of example, many of
the connection methods described in PCT Application No.
PCT/US2014/070869, which is incorporated by reference herein in its
entirety, may be utilized to connect the anvil and the cartridge
described herein.
[0159] In one embodiment, the surgeon, using standard laparoscopic
instruments and graspers, may position the end effector 40
proximate the stomach 10 as is shown in FIG. 2B. In this regard,
FIG. 2B illustrates the end effector 40 placed around the stomach
10 with the anvil 42 and the cartridge 44 coupled together with the
flexible member 46 at both the proximal end 14 and the distal end
16 of the stomach 10. The length of the anvil 42 and the cartridge
44 may be sufficient for the anvil 42, the cartridge 44, and the
flexible member 46 to encircle the stomach 10, as shown. The length
of the anvil and/or the cartridge as described herein is not
particularly limited. By way of example and not limitation, the
length of each may measure from about 35 mm to about 350 mm. The
end effector 40 may be put in place and used with or without having
to mobilize the greater curvature 28. For example, a surgeon may
prefer to leave the greater curvature 28 attached to the omentum
(not shown), which could improve stability of the stomach 10 during
stapling.
[0160] As is described below, the flexible member 46 may be coupled
to a tensioning mechanism by which the anvil 42 and the cartridge
44 may be moved toward one another and to provide a sufficient
clamping force on the stomach 10. Once the end effector 40 is
properly positioned, as is shown in FIG. 2B, the surgeon may then
engage the tensioning mechanism, described below, to compress the
anvil 42 and the cartridge 44 on the stomach 10, as is shown by the
arrow 50 in FIG. 2B. In this regard, the end effector 40 may be
coupled to a device that houses the tensing mechanism for
tensioning the flexible member 46. As the anvil 42 and the
cartridge 44 are brought together, the flexible member 46 may align
the anvil 42 with the cartridge 44. In this regard, the end
effectors disclosed herein may be self-aligning due, in part, to
coupling of the anvil 42 to the cartridge 44 at each end.
Tensioning the flexible member 46 may also compress the tissue. For
instance, as the flexible member 46 is tensioned, the distance
between the anvil 42 and the cartridge 44 decreases, and ultimately
compresses the stomach 10. In accordance with embodiments of the
invention, a gap between the anvil 42 and the cartridge 44 may vary
when the surgeon clamps the stomach 10. As is described in detail
below, the variation in the gap may reflect variation in the
thickness of the tissue clamped between the anvil 42 and the
cartridge 44.
[0161] In one aspect of the invention, the end effector 40 may be
positioned relative to the stomach 10 using a two-stage clamping
process in which the surgeon operates the tensioning mechanism to
clamp the anvil 42 and the cartridge 44 onto the stomach 10. In the
first clamping stage, the anvil 42 and the cartridge 44 may be
clamped onto the stomach 10 to provide a threshold amount of
resistance to unintentional movement of the end effector 40
relative to the stomach 10. For example, the range of clamping
pressure in the first stage may be about 0.1 g/mm2 to about 4
g/mm2. While preventing undesirable or unintentional movements of
the end effector 40, the surgeon may move the end effector 40 to a
desired position relative to the stomach 10 without significant
difficulty.
[0162] In the second clamping stage, and with the end effector 40
in the desired location relative to the stomach 10, the clamping
force of the end effector 40 may be increased to effectively
prevent or minimize the end effector 40 from moving relative to the
stomach 10. For example, the clamping pressure in the second stage
may be about 4 g/mm2 to about 70 g/mm2. In an exemplary embodiment,
the clamping pressure in the second stage may be about 8 g/mm2. The
upper limit to which the end effector 40 may be clamped is selected
so as to avoid any damage to the underlying tissue being clamped
but also allow for adequate tissue compression for staple
formation. This upper limit may be, for example, about 70 g/mm2.
Additionally, the lower limit in the disclosed range of about 4
g/mm2 represents a threshold clamping force below which constitutes
the first stage clamping and above which constitutes the second
stage clamping. It will be recognized that these values are merely
exemplary and the particular values may depend on several factors,
including the anatomical structure being clamped. Thus, embodiments
of the invention are not limited to the range of values provided
herein. In accordance with embodiments of the invention, the gap
between the anvil 42 and the cartridge 44 may vary across the
longitudinal length of the end effector 40 when the surgeon clamps
the stomach 10 in the first and/or second stage.
[0163] In an advantageous aspect of the invention, when the end
effector 40 is placed on the stomach 10 (e.g., in the first
clamping stage as described above), the surgeon has a clear
visualization of the intended results of the vertical sleeve
gastrectomy prior to actually performing the resection of the
stomach 10 at the staple line 12. Hence, the surgeon has an
indication of what the resultant stomach shape and volume defined
by the lesser curvature 30 and the staple line 12 will likely be
prior to stapling and/or cutting the stomach tissue. If the surgeon
is not satisfied with the indication of the expected stomach shape
and volume, the surgeon may adjust and manipulate the location and
the alignment of the end effector 40 prior to stapling and cutting
the stomach 10. This is in contrast to current procedures, where
the resection line is generally not well visualized prior to
activating the stapler. Thus, according to current procedures, the
ultimate outcome is less certain. It will be appreciated that the
end effector 40 should be positioned such that it does not provide
lateral stretching or tension of the stomach 10, which may create
an undesirable environment for stapling and cutting. Using the end
effector 40 ensures proper alignment of the staple line 12 so that
removing the fundus 26 occurs at a safe distance away from both the
lesser curvature 30 and the gastro esophageal junction 22. The
result is a staple line that is squared off at the fundus 26 of the
stomach to prevent or reduce the likelihood of necrotic tissue
development.
[0164] Once the end effector 40 is positioned and the anvil 42 and
the cartridge 44 are compressed, the surgeon may activate a cutting
and stapling mechanism, described below, to cut and staple the
tissue using the end effector 40 until complete resection of the
stomach 10 occurs, as is illustrated in the sequence of FIGS. 2C,
2D, and 2E. In one embodiment, the surgeon may engage a release
mechanism after completing the resection of the stomach 10. This
allows slack to be introduced in the flexible member 46 such that
the anvil 42 may be separated from the cartridge 44. Consequently,
once the anvil 42 and the cartridge 44 are separated, the end
effector 40 may be removed from the abdominal cavity.
[0165] With reference to FIGS. 3-10D, the surgeon may operate the
end effector 40 above, including one or both of the anvil 42 and
the cartridge 44, during a vertical sleeve gastrectomy procedure
with a mechanical device that is operably coupled to the one or
both of the anvil 42 and the cartridge 44. With specific reference
to FIG. 3, in one embodiment, an endocutter stapling device 100
includes the end effector 40 operatively coupled to a manipulator
102. With the endocutter stapling device 100, the surgeon may
remotely operate the end effectors disclosed herein. While specific
reference is made to the endocutter stapling device 100, other
stapling devices may be utilized in accordance with the present
invention including, for example, the endocutter stapling devices
described in commonly owned U.S. Application with attorney docket
number SBAR-09WO, which is incorporated by reference herein in its
entirety.
[0166] As shown in FIG. 3, the manipulator 102 includes an elongate
member or shaft 104 coupled to a handpiece 106 at one end and the
end effector 40 at the other end thereof. During a surgical
procedure, the end effector 40 and a portion of the shaft 104 may
be inserted into the patient, such as via a trocar. The surgeon may
then manipulate the end effector 40 and/or articulate the end
effector 40 relative to the manipulator 102 to perform a procedure.
Thus, embodiments of the present invention may include mechanisms
for effectuating a surgical procedure with the end effector 40
(including clamping, stapling, and cutting tissue) and for allowing
the end effector 40 to articulate relative to the shaft 104, each
described below.
[0167] With reference to FIGS. 3, 4, and 4A, the anvil 42 and the
cartridge 44 are movably coupled together via the flexible member
46 as is described above. The flexible member 46 passes through
hollow portions of the anvil 42 and the cartridge 44 and is movable
relative to one or both of the anvil 42 and the cartridge 44. The
flexible member 46 may be anchored to one of the anvil 42 or the
cartridge 44, as is described below. In the exemplary embodiment
shown, the anvil 42 may be separated from or brought closer to the
cartridge 44 by extending or retracting the flexible member 46.
Retraction of the flexible member 46 moves the anvil 42 toward the
cartridge 44 as is shown generally by arrow 52 in FIG. 4A.
[0168] In this regard, in the exemplary embodiment shown in FIGS.
4-6, the flexible member 46 extends from the shaft 104 into the
cartridge 44 at a proximal end 44b and ultimately couples the anvil
42 to the cartridge 44. While numerous pathways for the flexible
member are possible, in the exemplary embodiment, the flexible
member 46 passes from the cartridge 44 and is coupled to the anvil
42 adjacent each of a distal end 42a and a proximal end 42b thereof
and may be anchored within the anvil 42 by anchors 110 and 112
(shown in FIG. 6).
[0169] Retraction of the flexible member 46 from the end effector
40 (and into the manipulator 102 described below) therefore moves
at least one of the anvil 42 and/or the cartridge 44 as is shown
generally by the arrow 52 in FIG. 6. It will be appreciated that
because the flexible member 46 is anchored to the anvil 42 (e.g.,
proximate each of the distal end 42a and the proximal end 42b),
retraction of the flexible member 46 produces a substantially
symmetrical closing force on tissue situated between the anvil 42
and the cartridge 44. This configuration, that is, with
connectivity between the anvil 42 and the cartridge 44 at each end
of the end effector 40, is advantageous.
[0170] In this regard, in embodiments in which the anvil 42 and/or
the cartridge 44 are sufficiently rigid at pressures encountered
during a surgical procedure, the clamping force may be more
symmetrical and uniformly distributed along the length of the anvil
42 and the cartridge 44. Thus, the tissue situated between the
anvil 42 and the cartridge 44 may be more uniformly compressed. It
will be appreciated that even though there may be more uniform
compression on the tissue, the anvil 42 and the cartridge 44 may
not be parallel to one another in the clamped position because the
tissue may not be uniformly thick. Nevertheless, there may be
uniformity in applied pressure. Alternatively, the anvil 42 and the
cartridge 44 may be generally parallel yet a gap between the
opposing faces of each varies in dimension between a distal end and
a proximal end of the end effector 40. The variation in gap may be
according to a predetermined relationship to accommodate for the
change in thickness of the compressed stomach during clamping. Even
though the gap may vary in dimension from one end to the other, the
end effector 40 may uniformly apply pressure to the clamped tissue.
In each instance, this may be unlike prior art devices in which
clamping members are attached together at a single, hinge-like
location and have a jaw-like motion, rather than a vice-like
motion. With a single connection, the end of the clamp member most
distant from the connection may deflect. As a result of the
deflection, the clamp member may not apply uniform, symmetrical
compression to the tissue along its length. Furthermore, deflection
becomes more exaggerated as the clamp members lengthen. Thus,
deflection limits the practical upper limit on length for
hinge-like devices. It was recognized that producing a
substantially uniformly applied clamping pressure may enhance the
formation of the staple line following stapling and cutting.
[0171] With reference to FIGS. 3, 4, 5, and 6, in one embodiment,
the manipulator 102 includes a main body 114 with housing halves
120a, 120b. When assembled, the housing halves 120a, 120b enclose
control features by which the surgeon may operate clamping of the
anvil 42 and the cartridge 44 on the stomach 10 and then stapling
and cutting of the stomach 10. In that regard, the manipulator 102
includes a clamping mechanism 122 for applying tension to the
flexible member 46, a stapling mechanism 124 for stapling the
tissue captured between the anvil 42 and the cartridge 44, and a
cutting mechanism 126 for cutting the tissue. Each of these
mechanisms is described below. Thus, in one aspect, the surgeon may
operate the clamping mechanism 122 to control the extension and
retraction of the flexible member 46 from the end effector 40. In
another aspect, the surgeon may actuate the stapling mechanism 124
to fire staples and actuate the cutting mechanism 126 to cut
tissue. It will be appreciated that while the endocutter stapling
device 100 is described herein as including each of these
mechanism, that is, a clamping mechanism, a stapling mechanism, and
a cutting mechanism, the invention is not limited to having a
cutting mechanism. Specifically, the endocutter stapling device 100
may include a stapling mechanism and not include a cutting
mechanism. The surgeon may therefore use the endocutter stapling
device 100 to clamp and staple the tissue without cutting it.
[0172] To these and other ends, with continued reference to FIG. 5,
the manipulator 102 includes a support 130 having a U-shaped
cross-section coupled to the end effector 40 at a proximal end. A
guide beam 136 of about the same length as the support 130 and
reinforces the support 130. The guide beam 136 may include three
channels 138a, 138b, and 140 that may receive portions of each of
the stapling mechanism 124, the cutting mechanism 126, and the
clamping mechanism 122, described below.
[0173] In the embodiment shown, the manipulator 102 further
includes a frame 150 having a shaft portion 152 and a handpiece
portion 154. The shaft portion 152 may have a tubular
configuration, for example, a right circular tubular configuration
and may enclose the support 130 and the guide beam 136 when the
manipulator 102 is assembled. The support 130 may be configured to
receive a pin 142 that cooperates with a corresponding bore 144 in
the shaft portion 152 to secure the support to the frame 150.
[0174] The handpiece portion 154 of the frame 150 is enclosed in
the handpiece 106 and includes opposing flanges 156a, 156b defining
a channel 158. Each of the flanges 156a, 156b includes one or more
slots that guide a portion of the clamping mechanism 122, described
below. In the embodiment shown, each flange 156a, 156b includes two
pairs of slots 160a, 160b, 162a, 162b. The pair of slots 160a, 162a
on the flange 156a is a mirror image of the pair of slots 160b,
162b on the flange 156b. As shown, each of the slots 160a, 160b is
elongated in a direction generally parallel with the longitudinal
axis of the manipulator 102. The slots 162a, 162b are also
elongated but are angled with respect to the longitudinal axis of
manipulator 102 and angled relative to the slots 160a, 160b.
[0175] The clamping mechanism 122 includes a lever 170 pivotably
coupled relative to the housing halves 120a, 120b by the pin 142 in
the bore 144. The surgeon operates the lever 170 to tension the
flexible member 46. In particular, with reference to FIGS. 6 and 7,
the surgeon may squeeze the lever 170 by which motion the flexible
member 46 is withdrawn from the end effector 40. As is described
above, withdrawing or pulling the flexible member 46 from the end
effector 40 draws the anvil 42 toward the cartridge 44 and may
tension the flexible member 46 when the anvil 42 and the cartridge
44 meet resistance to movement. By applying a force to the flexible
member 46, the anvil 42 and the cartridge 44 may be moved toward
one another (as is indicated by arrow 52) and may also apply a
clamping force to tissue situated between the anvil 42 and the
cartridge 44. It will be appreciated that the surgeon may operate
the lever 170 with one or more fingers during operation of the
endocutter stapling device 100 between a disengaged position (e.g.,
FIGS. 3 and 6) in which the clamping mechanism 122 does not
restrict movement of the flexible member 46 and an engaged position
(e.g., FIGS. 4 and 7) in which the clamping mechanism 122 contacts
the flexible member 46.
[0176] To that end, the clamping mechanism 122 further includes a
push bar 164 pivotably coupled to the lever 170 by a pin 166 at one
end thereof. The push bar 164 extends from outside the housing half
120a, where it is pivotally attached to the lever 170 by the pin
166, into the channel 158 of the frame 150 through a slot
(unlabeled) in the handpiece portion 154 of the frame 150. The push
bar 164 is pivotally coupled to a push bar 174 by a pin 172 in the
handpiece 106. The pin 172 extends through the push bar 164 at one
end thereof across the channel 158 and is slidably received in each
of the slots 160a, 160b (FIG. 5) of the frame 150. The push bar 174
is coupled to a second pin 176 at the opposing end of the bar 174
from the pin 172. The pin 176 is slidably received in each of the
slots 162a, 162b (FIG. 5) of the frame 150. The pins 172 and 176
interact with the flexible member 46 when the surgeon squeezes the
lever 170. By way of example only, and not limitation, one or both
of the pins 172 and 176 may be coupled to a sheave (not shown),
which slidably receives the flexible member 46, to guide the
flexible member 46 during operation of the clamping mechanism
122.
[0177] With continued reference to FIG. 6, the flexible member 46
extends from the shaft 104, between the flanges 156a, 156b, and is
looped over the pin 172 and the pin 176 (e.g., in sheaves on each
pin 172, 176). In the exemplary embodiment, an additional pin 178
may extend across the channel 158 in fixed relation to the frame
150. The pin 178 may be positioned at a location that maintains the
flexible member 46 in alignment with the shaft 104. In other words,
the pin 178 may be configured to align the flexible member 46 with
the shaft 104 independent of the position of the pins 172, 176 as
the pins 172, 176 slide in relation to the slots 160a, 160b, 162a,
162b. Thus, while the flexible member 46 may move in response to
actuation of the clamping mechanism 122 along each of the pins 172,
176, the additional pin 178 may maintain alignment of the flexible
member 46 with the longitudinal axis of the manipulator 102.
[0178] With reference to FIGS. 6 and 6A, depression of the clamping
lever 170 toward the housing half 102a in the direction of the
arrow 180 in FIG. 6 may cause movement of each of the push bars
164, 174 generally away from the end effector 40 in the direction
of the longitudinal axis of the handpiece 106. Specifically, as is
shown in FIG. 6, the push bars 164, 174 initially have a generally
L-shaped arrangement when the lever 170 is extended from the
handpiece 106. In this disengaged position of the lever 170, the
anvil 42 is spaced apart from the cartridge 44, as is shown in
FIGS. 6 and 6A. As the lever 170 is compressed towards the
handpiece 106 (according to the arrow 180), the push bar 164 pushes
the pin 172 along the slots 160a, 160b (according to the arrow
184). This movement also simultaneously forces the push bar 174
along the longitudinal axis of the manipulator 102 as guided by the
pin 172 in the slots 162a, 162b (according to the arrow 186). The
pins 172, 176 carry the flexible member 46 in the same direction
away from the end effector 40. Overall, the flexible member 46 is
withdrawn from the end effector 40 resulting in movement of the
anvil 42 toward the cartridge 44. In accordance with embodiments of
the invention, a gap between the anvil 42 and the cartridge 44 may
vary when the surgeon clamps the stomach 10. In this regard, the
clamping mechanism may be configured to create a gap at the distal
end 42a, 44a of the end effector 40 that is less than the gap at
the proximal end 42b, 44b of the end effector when the clamping
mechanism is engaged. In one embodiment of the invention, the
clamping mechanism may be configured to withdraw the flexible
member 46 from the end effector 40 such that the length of flexible
member between the distal ends 42a, 42b of the anvil 42 and the
cartridge 44 is less than the length of flexible member 46 between
the proximal ends 42b, 44b of the anvil 42 and the cartridge 44. As
is described below, the anvil 42 may therefore be intentionally
tilted relative to the cartridge 44 such that the gap is not
uniformly formed between the anvil 42 and the cartridge 44. This
gap configuration may then be imposed on the stomach 10 though it
may produce more uniform pressure distribution on the stomach 10.
Those of ordinary skill in the art will recognize that there may be
other configurations resulting in a varying gap between the anvil
and the cartridge that are useful in embodiments of the present
invention.
[0179] Compression of the lever 170 into the engaged position
results in the configuration of the endocutter stapling device 100
shown in FIGS. 7 and 7A, in which the push bars 164, 174 are
generally aligned with respect to one another and the anvil 42 and
cartridge 44 are compressed onto the stomach 10. In the generally
aligned configuration between the push bars 164, 174, the path
around which the flexible member 46 extends is lengthened relative
to the L-shaped arrangement shown in FIG. 6. By lengthening the
path, the flexible member 46 is carried rearwardly within the
handpiece 106 during actuation of lever 170. This results in a
corresponding withdrawal of the flexible member 46 from the end
effector 40. Accordingly, the compression of the lever 170 toward
the housing half 120a pulls the anvil 42 towards the cartridge 44
as is indicated by arrow 52 in FIG. 7. This motion may result in
compression of the stomach 10 between the anvil 42 and the
cartridge 44, as is shown in FIG. 7A. By way of example and not
limitation, the clamping mechanism 122 may be capable of tensioning
the flexible member 46 to about 200 lb at each end of the anvil 42.
This may provide a clamping pressure of over 100 psi. Specifically,
in an exemplary embodiment, the anvil 42 and the cartridge 44 may
have a length of about 250 mm and a width of about 10 mm providing
a surface area of about 25 cm2. With 400 lb of total tension on the
flexible member 46 (i.e., 200 lb on each side), the total
compression pressure may be about 103 psi.
[0180] With reference now to FIG. 6A, in one embodiment, the anvil
42 includes a plurality of staple pockets 190 along a face 192 of
the anvil 42. The cartridge 44 includes a face 194 that opposes the
face 192 of the anvil 42. Each of the faces 192, 194 is configured
to compress the stomach 10 there between. The staple pockets 190 in
the face 192 generally align and correspond to a plurality of
staples 198 and a plurality of staple drivers 200 that are housed
in a plurality of staple channels 206 defined by the cartridge 44.
The cartridge 44 includes a cartridge body 196 that may support the
staples 198 and the staple drivers 200. The staples 198 are
configured to be forced through the stomach 10 and be deformed by
the staple pockets 190. It will be appreciated that deforming the
staples 198 into a B-shaped configuration secures opposing sides of
the stomach 10 together.
[0181] In one embodiment, to facilitate alignment between the anvil
42 and the cartridge 44, and in particular, alignment between the
staples 198 and the staple pockets 190, an alignment pin 202 may
extend beyond the face 192 at the distal end 42a of the anvil 42 or
the face 194 at the distal end 44a of the cartridge 44. The other
face 192, 194 of the anvil 42 or the cartridge 44 includes a mating
recess 204. Once the lever 170 is compressed, the flexible member
46 is pulled into the handpiece 106 by the clamping mechanism 122
as described above. This motion pulls the anvil 42 toward the
cartridge 44 and the alignment pin 202 in conjunction with the
mating recess 204 to facilitate proper alignment between the anvil
42 and the cartridge 44 to align the staples 198 with a
corresponding pocket 190. With reference to FIG. 7A, the anvil 42
and the cartridge 44 are shown to compress the stomach 10 between
the face 192 of the anvil 42 and the face 194 of the cartridge 44
with the alignment pin 202 being received in the mating recess 204.
In another aspect of the present invention, once the lever 170 is
compressed, as is shown in FIG. 7, with the anvil 42 and the
cartridge 44 compressing the stomach 10 there between, the surgeon
may staple and cut the stomach 10 along the staple line 12 (FIG.
1). To staple the stomach 10, the surgeon activates the stapling
mechanism 124.
[0182] In that regard and with reference to FIGS. 3, 8, and 9, the
stapling mechanism 124 includes a staple actuator 210 having a
thumb tab 212. The staple actuator 210 further includes an actuator
plate 214 that is coupled to the thumb tab 212. The actuator plate
214 is slidably received in a slot 218 (FIG. 3) formed between the
housing halves 120a, 120b and is movable relative to the handpiece
106 as is indicated by the arrow 232 in FIGS. 8 and 9. The actuator
plate 214 includes slots 222a, 222b spaced apart from an elongated
slot 224. In the embodiment shown, the slots 222a, 222b each
receive a wedge push bar 226a, 226b, respectively. As is shown in
FIGS. 5 and 10, the wedge push bars 226a, 226b are elongated
members that extend generally along the length of the handpiece 106
and through the shaft 104 and terminate proximate the end effector
40. The wedge push bars 226a, 226b are slidably received in
corresponding channels 138a, 138b of the guide beam 136 and are
positioned to slide into engagement with the staples 198 and the
staple drivers 200 in the cartridge 44.
[0183] In one embodiment, shown in FIG. 10, each wedge push bar
226a, 226b terminates in a wedge tip 230a, 230b which, prior to
activation of the stapling mechanism 124, is positioned to engage
respective rows of the staple drivers 200 in the cartridge 44. The
wedge tips 230a, 230b have a wedge-shaped configuration and, during
a sliding motion through the end effector 40, are configured to
force the staple drivers 200 toward the anvil 42 and drive the
corresponding staples 198 through the compressed stomach 10 and
into contact with the corresponding staple pockets 190 of the anvil
42. As shown best in FIGS. 10 and 10B, the shape of the wedge tips
230a, 230b forces the staples 198 into contact with the staple
pockets 190 of the anvil 42 with sufficient force to deform the
staples 198 and produce a B-shaped staple.
[0184] In one embodiment, the surgeon activates the stapling
mechanism 124 by pushing the thumb tab 212 in the direction of the
end effector 40 as is indicated by the arrow 232 in FIGS. 8 and 9.
Pushing the thumb tab 212 slides each of the wedge push bars 226a,
226b and the corresponding wedge tips 230a, 230b in the direction
of the end effector 40. Specifically, and with reference now to
FIGS. 10C-10D, pushing the thumb tab 212 (FIG. 8) moves the wedge
push bars 226a, 226b in the direction of the arrow 234. The wedge
tip 230a engages the staple drivers 200 in sequence and thereby
forces the staples 198 into the corresponding staple pockets 190 on
the anvil face 192 as is indicated by the arrows 238.
[0185] In another aspect of the present invention, the surgeon may
cut the stomach 10 along the staple line 12 following stapling,
described above. In one embodiment and with reference to FIG. 5, to
cut the stomach 10, the surgeon activates the cutting mechanism
126. The cutting mechanism 126 includes a knife actuator 248
including the thumb tab 212 coupled to the actuator plate 214. As
described above and with reference to FIGS. 8 and 9, the actuator
plate 214 is slidably received in the slot 218 formed between the
housing halves 120a, 120b and is movable relative to the handpiece
106 in a direction that is indicated by the arrow 232 in FIGS. 8
and 9.
[0186] With reference to FIGS. 10-10A, in one embodiment, the
cutting mechanism 126 includes the elongated slot 224 in the
actuator plate 214. A knife push bar 250 is slidably engaged in the
elongated slot 224 and may be an elongated member extending from
the actuator plate 214 through the handpiece 106 and the shaft 104
to a location adjacent the end effector 40. In that regard, the
knife push bar 250 is slidably received in the channel 140 of the
guide beam 136 and terminates in a cutting edge 252 proximate the
end effector 40 (shown best in FIGS. 10-10D). As can be appreciated
specifically by FIGS. 5, 10C and 10D, the knife push bar 250 lies
in between the wedge push bars 226a, 226b. In one embodiment, the
surgeon activates the cutting mechanism 126 by pushing the thumb
tab 212 in the direction of the end effector 40 as is indicated by
the arrow 232 in FIG. 8. Pushing the thumb tab 212 slides the knife
push bar 250 via the actuator plate 214 and pushes the
corresponding cutting edge 252 in the direction of the end effector
40.
[0187] Specifically, and with reference now to FIGS. 10, 10A, and
10B, pushing the thumb tab 212 moves the cutting edge 252 in the
direction of the arrow 254 along the longitudinal axis of the
endocutter stapling device 100. Although not shown, the cutting
edge 252 cuts the stomach that may be clamped between the anvil 42
and the cartridge 44.
[0188] In one embodiment, and with reference to FIGS. 8 and 9, the
thumb tab 212 may activate each of the stapling mechanism 124 and
the cutting mechanism 126. As is described above, the actuator
plate 214 captures each of the wedge push bars 226a, 226b and the
knife push bar 250 in slots 222a, 222b and elongated slot 224,
respectively. In one embodiment, even though the actuator plate 214
is operably coupled to each of the wedge push bars 226a, 226b and
the knife push bar 250, engagement of the stapling mechanism 124
occurs prior to actuation of the cutting mechanism 126. In other
words, the stapling mechanism 124 engages prior to engagement of
the cutting mechanism 126. The elongated slot 224 in the actuator
plate 214 is oversized relative to the portion of the knife push
bar 250 that is engaged with it. This configuration results in
sliding space between the elongated slot 224 and the knife push bar
250. The knife push bar 250 therefore slides relative to the
actuator plate 214 during initial movement of the actuator plate
214. The length of the movement of the actuator plate 214 without
movement of the knife push bar 250 is predetermined.
[0189] The elongated slot 224 is also longer than each of the slots
222a, 222b. Because the knife push bar 250 is slidably received in
the elongated slot 224, the initial movement of the actuator plate
214 in the direction of arrow 232 in FIG. 8 causes each of the
wedge push bars 226a, 226b to move in direct relation to the
movement of the actuator plate 214. The movement of the knife push
bar 250 is however delayed relative to the movement of the wedge
push bars 226a, 226b. This means that there is a delay between
activation of the stapling mechanism 124 and the cutting mechanism
126. This delay is proportional to the free sliding space between
the elongated slot 224 and the knife push bar 250.
[0190] When the surgeon pushes the thumb tab 212 in the direction
of the arrow 232 in FIG. 8, the actuator plate 214 moves in the
same direction and carries the wedge push bars 226a and 226b with
it. The knife push bar 250 does not initially move. Instead, the
actuator plate 214 must move a predetermined distance corresponding
to the free sliding space in the direction of the end effector 40
before the actuator plate 214 engages the knife push bar 250. This
is shown by way of comparison between FIGS. 8 and 9. In FIG. 8, the
actuator plate 214 has not engaged the knife push bar 250. In FIG.
9, the actuator plate 214 has moved a distance at least equivalent
to the free sliding space and so the actuator plate 214 engages the
knife push bar 250. This delay in movement between the wedge push
bars 226a, 226b and the knife push bar 250 results in a difference
in activation time between the stapling mechanism 124 and the
cutting mechanism 126. In this manner, in one embodiment,
activation of the stapling mechanism 124 precedes activation of the
cutting mechanism 126.
[0191] Once the surgeon activates each of the stapling mechanism
124 and the cutting mechanism 126 by pushing on the thumb tab 212,
stapling and cutting may occur substantially simultaneously. By way
of example only, the stapling of the stomach 10 may precede the
cutting of the stomach 10. That is, after an initial delay between
stapling and cutting, during which the stapling mechanism 124 is
activated, both of the stapling mechanism 124 and the cutting
mechanism 126 are active. The surgeon may continue stapling and
cutting the stomach 10 by continuing to push on the thumb tab 212
until the thumb tab 212 reaches the end of its stroke. It will be
appreciated that the stroke of the thumb tab 212 may be greater
than the overall length of the stomach 10. Further, the stroke of
the thumb tab 212 may be approximately equal to the length of the
end effector 40. At this point, the wedge tip 230a, 230b may be
proximate the distal end 42a, 44a of the end effector 40. The end
effector 40 and the shaft 104 may then be removed from the
abdominal cavity with the stomach 10 having the configuration shown
in, for example, FIG. 2E. Tensioning, stapling, and cutting
mechanisms are further described in the commonly-owned U.S.
Application No. II having the attorney docket number SBAR-09WO,
which is filed concurrently with the present application and is
being incorporated by reference herein in its entirety.
[0192] With reference again to FIG. 1, as described above, the
stomach 10 may vary in thickness from the antrum 24 to the fundus
26. Stomach specimens removed from patients have been analyzed for
tissue thickness at three points along a resection line--the antrum
24, the fundus 26, and a mid-way point between the antrum 24 and
the fundus 26 called the body. These values were used to estimate
closed staple leg heights at these three locations. A closed staple
leg height may be estimated based on a known tissue thickness along
the staple line. Closed staple leg height refers to the height
dimension of a deformed staple. Open staple leg height may be
calculated from a closed staple leg height. Open staple leg height
refers to the height dimension of a new staple. Thus, prior to
stapling, each staple has an open staple leg height. During
stapling, the staple may be forcibly deformed. Ideally, each leg of
a staple is deformed to produce a B-shaped staple in which a tooth,
sometimes referred to as a point, of each leg points in the
direction of the crown. Following stapling, each deformed staple
has a closed staple leg height. The average closed staple leg
heights were estimated to be about 1.8 mm, about 2.4 mm, and about
3.0 mm for the fundus, the body, and the antrum, respectively. The
average open staple leg heights were calculated to be about 3.8 mm,
about 4.4 mm, and about 5.0 mm for the fundus, the body, and the
antrum, respectively. Not being bound by theory, it is believed
that the tissue thickness provides information regarding the closed
staple leg height at a particular location. When all of the
specimens and the estimated closed staple leg heights are
considered, according to an embodiment of the invention, a
relationship between the closed staple leg height and the variation
in thickness of the human stomach along a targeted resection line
was determined.
[0193] In this regard, an increase in average thickness from the
fundus 26 to the antrum 24 was calculated. The increase was
determined to be approximately linear with a degree of the increase
in the average thickness of the stomach along the resection lines
of these stomach specimens of about 0.382 degrees. As shown in FIG.
2B, the end effector 40 extends across the length of the stomach
10. When compressed, a gap between the anvil 42 and the cartridge
44 varies in a predetermined relationship relative to this change
in tissue thickness. Accordingly, aspects of the present invention
may utilize predetermined changes in gap dimensions at defined
locations between the anvil 42 and the cartridge 44 along a
longitudinal axis of the end effector 40.
[0194] To that end, in one embodiment and with reference to FIG.
11, an end effector 360 includes a gap 370 between the anvil 362
and the cartridge 364 at a proximal end 366 of the end effector 360
("proximal gap 370") and a gap 372 at a distal end 368 of the end
effector 360 ("distal gap 372"). The proximal gap 370 is different
from the distal gap 372. Specifically, the anvil 362 has a face 376
that includes a plurality of staple pockets 378, and the cartridge
364 has a face 380 that opposes the face 376 of the anvil 362. The
proximal gap 370 and the distal gap 372 are measured between the
faces 376 and 380. The orientation between the face 376 and the
face 380 may therefore determine the gaps 370 and 372. In one
embodiment, the proximal gap 370 is larger than the distal gap 372
when the stomach 10 is compressed between the anvil 362 and the
cartridge 364. The difference between the gap 370 and the gap 372
may be determined based on the anatomy of the stomach 10 described
above. By way of example, and not limitation, the distal gap 372
may range from, for example, about 1.5 mm to about 3.3 mm, and the
proximal gap 370 may be in the range of about 2.0 mm to about 5.0
mm. Further, and without limitation, the angle of increase in the
gap from the distal gap 372 to the proximal gap 370 may be from
about 0.1.degree. to about 1.degree..
[0195] Furthermore, the orientation between the anvil 362 and the
cartridge 364 may determine all of the distances between the two
faces 376, 380 from the proximal end 366 to the distal end 368. For
example, with continued reference to FIG. 11, the face 376 of the
anvil 362 may not be parallel with the face 380 of the cartridge
364. As shown, the face 376 may be uniformly sloped at an angle a
relative to the face 380 of the cartridge 364. The distances
between the face 376 and the face 380 may linearly decrease from
the proximal gap 370 to the distal gap 372 according to the angle
a. The angle a may be proportional to a corresponding change in the
average closed staple leg heights according to a corresponding
location along the staple line 12 on the stomach 10. That is, in
one embodiment, the angle a may be directly related to a measured
angle across the average closed staple leg heights by location on
the stomach. By way of example only, and not limitation, the distal
gap 372 may be about 1.7 mm, the proximal gap 374 may be about 3.3
mm, and the angle a may be about 0.367 degrees.
[0196] As is shown in FIG. 11 and is described in more detail
below, the cartridge 364 houses staples 198 and staple drivers 200.
Further, the cartridge 364 may be divided into zones in which the
staples 198 differ in open leg length. The open leg length of the
staples 198 may vary in accordance with the thickness of the
stomach 10 when compressed. It should be recognized that these
values are merely exemplary and the particular values for the
distal and proximal gaps may depend on several factors, including
the anatomical structure being clamped as well as other factors.
Thus, the invention is not limited to the range of values provided
herein. Various aspects of the present invention address the
varying gap between the anvil and the cartridge to improve the
quality and consistency of the staple line.
[0197] It will be recognized that the varying gap between the anvil
and the cartridge along the length of the end effector may affect a
delta gap of the formed staples. The delta gap is the difference in
the gap between the leading leg and the staple crown and the gap
between the lagging leg and the staple crown. In this regard, an
end effector with a gap having an angle of about 0.382 degrees and
including staples with a crown length of 2.65 mm, may produce a
delta gap of about 0.0177 mm. This does not exceed known exemplary
delta gaps in staples formed using open linear staplers such as
0.21 mm and 0.29 mm.
[0198] In an alternative configuration in which like reference
numerals refer to like features throughout the figures, and with
reference to FIGS. 12A-12C, in one embodiment, an end effector 400
includes an anvil 402 and a cartridge 404. The anvil 402 has a face
406, and the cartridge 404 has a face 408. As shown, a shim 410 is
coupled to each of the anvil 402 and the cartridge 404. Each shim
410 increases in thickness from the proximal end 366 to the distal
end 368 of the anvil 402. An exemplary shim is shown in FIG. 13. A
shim 410 maybe formed from material that is bio-absorbable. The
material may also be flexible, and, if it is a polymer, the
material may be such that it will not cross link further to become
a rigid structure. By way of example, and not limitation, the shim
material may include dilactones, bioresorbable elastomer made from
poly(glycerol sebacate), polylactide (PLA), polyglycolide (PGA), a
copolymer of E-caprolactone and glycolide, or a non-absorbable
polymer such as polytetrafluoroethylene (PTFE). The shim material
may also include biologic materials such as bovine pericardium,
small intestinal submucosa laminate, or acellular dermal
matrix.
[0199] The change in thickness of each shim 410 may be determined
based on the change in thickness of the stomach 10, described
above. By way of example, the thickness of each shim 410 at
predetermined locations along the length of the shim 410 may be
determined at least in part using the estimated thickness of the
stomach 10 and the gap between the face 406 of the anvil 402 and
the face 408 of the cartridge 404 at a given location along the
length of the stomach 10 when the faces 406 and 408 are
substantially parallel. By way of example, the thickness of each
shim 410 may be about one half of the difference in height between
the gap and the thickness of the stomach 10 (when compressed) at
each location between the faces 406 and 408. With this
configuration, the shims 410 compensate for the expected variation
in the compressed stomach thickness. When the stomach 10 is
compressed between the anvil 402 and the cartridge 404, the change
in thickness of the shims 410 and the corresponding change in
thickness of the stomach 10 provide a generally overall consistent
total gap between the faces 406 and 408 over the length of the end
effector 400.
[0200] With reference to FIGS. 12B and 12C, during actuation of the
end effector 400, as the wedges 230a, 230b push the staple drivers
(not shown) toward the anvil 402, the staples 198 pierce through
each of the shims 410 at the faces 406, 408 and come into contact
with the staple pockets (not shown). As is shown, once the staple
line is complete, the staples 198 having the same open leg length
(as is shown in FIG. 12A) will also have generally the same closed
leg length along the length of the staple line. Advantageously,
using the shims 410 may reduce the likelihood of improper staple
formation due to the variable thickness of the stomach 10 since the
gap between the faces 406 and 408 is substantially uniform from the
proximal end 366 to the distal end 368. Additionally, the presence
of the shims 410 may act as reinforcement to the staple line 12, as
can be appreciated from FIG. 12C in which the shims 410 form part
of the staple line 12. Further, because each of the staples 198 has
the same open leg length along the entire staple line 12, the
surgeon is not required to estimate the stomach thickness to
determine what staple open leg length should be placed in the
cartridge 404. Aspects of the present invention are not limited to
the illustrated arrangement, where both the anvil 402 and the
cartridge 404 include a shim 410. In one embodiment, for example,
the cartridge 404 may be coupled to a shim, while the anvil 402 is
not coupled to a shim. Other alternative arrangements may also be
possible.
[0201] In one embodiment and with reference to FIG. 14A, a shim 412
may extend along a part of the length of the anvil 402 and/or along
a part of the length of the cartridge 404. In FIG. 14A, one shim
412 extends from about the midway point of the anvil 402 to the
distal end 402a of the anvil 402 and another shim 412 extends from
about the midway point of the cartridge 404 to the distal end 404a
the cartridge 404. In this regard, the shims 412 are located
adjacent the thinner portion of the stomach 10 and are generally
thinner and shorter than the corresponding shims 410 shown in FIG.
12A-12C.
[0202] During actuation, some of the staples 198 pass only through
the stomach 10 from the cartridge 404 to the anvil 402, while other
staples 198 will pass through the shims 412 and the stomach 10
before reaching the staple pockets (not shown). Once the staple
line 12 is complete, the staples 198 having the same open leg
length will also have generally the same closed leg length along
the length of the stomach 10, as is shown in FIG. 14B. In other
words, the varying thickness of the shims 412 and the varying
thickness of the stomach 10 combine to provide a generally equal
thickness along the length of the staple line. Those of ordinary
skill in the art will recognize that aspects of the present
invention are not limited to the illustrated arrangement, in which
the shims 412 extends over generally half of the length of the
anvil 402 and cartridge 404.
[0203] With reference to FIG. 15A, in one embodiment, an end
effector 420 includes an anvil 422 and a cartridge 424 where a gap
between the anvil 422 and the cartridge 424 increases in a stepped
configuration from distal ends 422a, 424a to proximal ends 422b,
424b. In the exemplary embodiment, the face 428 of the cartridge
424 includes segments 430, 432, and 434. Each segment 430, 432, 434
resides in a plane that differs from planes for each of the other
segments 430, 432, 434 to produce three different gap dimensions
with the face 426 of the anvil 422. The different gap dimensions
may be related to the difference in thickness of the stomach 10
along the staple line 12, as is described above. As shown, the
staples 198 in each segment 430, 432, 434 may have the same open
leg length. To accommodate for the difference in height in each
segment 430, 432, 434, the staple drivers 200 vary in height by
segment 430, 432, 434. Thus, as the wedge (not shown) forces the
staple drivers 200 toward the anvil 422, the staples 198 will be
fully pushed out of the staple channels. While three segments 430,
432, 434 are shown, it will be appreciated that the face 428 of the
cartridge 424 may be defined by at least two segments and may be
defined by more than three segments. It should be appreciated that
there may be other configurations that allow for the staples 198 to
pass through the staple channels of varying height.
[0204] Once the end effector 420 has been fully actuated, the
staples 198 within each individual segment 430, 432, 434 will
generally have the same open leg length, as shown in FIG. 15B, but
differ in closed leg lengths compared to each of the adjacent
segments 430, 432, 434 due to the stepped configuration of the gap
between the anvil 422 and the cartridge 424. By way of example
only, the staples 198 near the proximal end of the staple line 12
will have a greater closed leg length than the staples 198 near the
distal end of the staple line 12. In an advantageous aspect of the
present invention, the stepped configuration of the cartridge 424
aids in providing a consistent staple deformation by taking into
account the varying thickness of the stomach 10. Further, the
surgeon is not required to determine what size staples to use based
on the expected thickness of the stomach 10.
[0205] It should be realized that aspects of the present invention
are not limited to the illustrated arrangements in FIGS. 15A-15B.
For instance, the face of the anvil may include a stepped
configuration similar to that of the cartridge 424 shown in FIG.
15A and provide a similar tiered difference in gap between opposing
faces of the anvil and the cartridge. By way of example, with
reference to FIGS. 16A and 16B, in which like reference numerals
refer to like features of FIGS. 15A and 15B, an end effector 440
includes an anvil 442 and a cartridge 444 where a gap between the
anvil 442 and the cartridge 444 increases in a stepped
configuration from the distal ends 442a, 444a to the proximal ends
442b, 444b. In the exemplary embodiment, the face 426 of the anvil
442 includes segments 450, 452, and 454. Each segment 450, 452, 454
resides in a plane that differs from planes for each of the other
segments 450, 452, 454 to produce three different gap dimensions
with the face 428 of the cartridge 444. The different gap
dimensions may be related to the difference in thickness of the
stomach 10 along the staple line 12, as is described above. As
shown, the staples 198 in each segment 450, 452, 454 may have the
same open leg length. Since there is no height difference in the
cartridge 444, the staple drivers 200 also have the same height in
each segment 450, 452, 454. Thus, as the wedge (not shown) forces
the staple drivers 200 toward the anvil 422, the staples 198 will
be fully pushed out of the staple channels. While three segments
450, 452, 454 are shown, it will be appreciated that the face 426
of the anvil 442 may be defined by at least two segments or may be
defined by more than three segments.
[0206] While each staple 198 within each segment 430, 432, 434 as
is shown in FIG. 15A and each staple 198 within each segment 450,
452, 454 as is shown in FIG. 16A, has an equivalent open leg
length, embodiments of the present invention are not limited to
embodiments in which each staple 198 has an equivalent open leg
length. With reference to FIGS. 17A and 17B, in which like
reference refer to like features throughout the figures. In an
exemplary embodiment, the end effector 420 cartridge 424 includes
four segments 430, 432, 434, 436 where the open leg lengths of the
staples 198 in each segment differ. The open leg lengths of staples
vary among manufacturers. For instance, blue, gold, green, and
black colors may be used to indicate staple having open leg lengths
of 3.5 mm, 3.8 mm, 4.1 mm, and 4.4 mm, respectively. By way of
example only, and not limitation, the segments 430, 432, 434, 436
may include black, green, gold, and blue staples, respectively.
While the staples 198 within each segment 430, 432, 434, 436 are
shown as having the same open leg length, it will be appreciated
that the open leg lengths of the staples 198 within each segment
430, 432, 434, 436 may be different, as is described below. The
segments 430, 432, 434, 436 may differ in relative proportion and
so embodiments of the present invention are not limited to each
segment 430, 432, 434, 436 having the same relative length. As a
result, the number of staples 198 in each segment 430, 432, 434,
436 may be different.
[0207] As is described above with respect to FIG. 11, in one
embodiment, the proximal gap 370 and the distal gap 372 may be
different and the face 376 of the anvil 362 may be oriented at an
angle a with respect to the face 380 of the anvil 362. Where the
gap between the distal end 368 and the proximal end 366 increases
linearly, the angle a between the face 376 of the anvil 362 and the
face 380 of the cartridge 364 may be determined. In a similar
configuration and with reference to FIG. 18, the end effector 360
may include zones of staples 198, with one or more zones having
staples 198 of different open leg lengths. The angle a may be used
to determine the incremental increase in the gap between the anvil
362 and the cartridge 364 for the purpose of selecting different
staples 198 for the zone. Based on this incremental increase, the
cartridge 364 may be divided into, for example, zones 1, 2, and 3,
as shown. The dimensions of each zone 1, 2, and 3 may be determined
according to a minimum closed leg length necessary to adequately
staple the tissue in that zone. And, the staples 198 in each zone
may have an open leg length that exceeds a minimum open leg length
necessary to provide the minimum closed leg length within that
zone.
[0208] Determining the minimum closed leg length according to zones
allows for a determination of the appropriate open leg length for
the staples 198 in the respective zone. With reference to FIG. 19,
and by way of example, and not limitation, the distal gap may be
about 1.7 mm, and the proximal gap may be about 3.3 mm. The angle a
may be approximately 0.367 degrees. This information may be used to
calculate zones of different open leg lengths. The number and
length of each zone may be varied based on the proximal gap and
distal gap of the end effector 360. In FIG. 19, the cartridge 364
includes three zones of, for example, blue (3.5 mm), gold (3.8 mm),
and green (4.1 mm) open staple leg lengths from the distal end to
the proximal end. Embodiments of the present invention are not
limited to the illustrated arrangement, where the cartridge 364
includes four zones of staples 198 having different open leg
lengths. Other alternative arrangements may also be possible.
[0209] In one embodiment, and with reference to FIGS. 20A-20C,
using the exemplary color-coded open staple leg lengths, the zones
1, 2, 3, and 4 of the cartridge 364 may use blue (3.5 mm), gold
(3.8 mm), green (4.1 mm), and black (4.4 mm) staples, respectively.
Each color is associated with a specific open leg length. After
completion of the staple line, the staples 198 within each zone 1,
2, 3, and 4 may have approximately the same closed leg length, as
shown in FIG. 20C.
[0210] According to one aspect of the present invention and with
reference to FIG. 21, in one embodiment, the cartridge 364 may be
randomly loaded with staples 198 having different open leg lengths.
In this manner, a random fill of the cartridge 364 may be
advantageous in that it "automatically" adjusts for the variation
in tissue thickness along the length of the staple line 12. That
is, within the random staples 198 it is likely that one or more
will exceed the minimum open leg length necessary to provide the
necessary closed leg length. After the staple line 12 is complete,
the closed leg lengths of the staples 198 will vary depending on
the open leg length and the gap between the cartridge 364 and the
anvil (not shown). Randomly filling the cartridge 364 with staples
198 of different sizes is an improvement over conventional staplers
where the surgeon is required to determine what size staples 198
should be used because at least a portion of the staples 198 in the
random fill are likely to be the appropriate length.
[0211] In one embodiment, the changing thickness of the stomach may
be used in part to determine what minimum open leg length to use in
each zone of a cartridge. A random selection of different staples
may be made with respect to that minimum. That is, a distribution
of staples of different open leg lengths may be selected with
staples having open leg lengths above and below the minimum open
leg length. With reference to FIG. 22, in one embodiment, the
staples 198 having different open leg lengths may be placed within
the cartridge 364 according to a probability based on the average
stomach thickness at that location. This is similar to the zones
described above but with staples having different open leg lengths
within a particular zone. Within each zone, the staples 198 may be
randomly filled. Further in this regard, the change in the gap
between the cartridge 364 and the anvil (not shown) may be
calculated along the length of the cartridge 364 and may be
utilized to further improve the probability determination on a zone
by zone basis. As is shown in FIG. 22, staples 198 having a larger
open leg length may be used more frequently near the antrum or near
the proximal end 366 of the cartridge 364, and staples 198 having a
shorter open leg height may be used more frequently near the fundus
or near the distal end 368 of the cartridge 364.
[0212] In one embodiment using these exemplary staples, staples 198
in one or more zones of the cartridge 364 adjacent the antrum 24
may include about 70% black staples, about 20% green staples, and
about 10% blue staples. Staples 198 in one or more zones of the
cartridge 364 adjacent the fundus 26 may include about 90% blue
staples and about 10% green staples. Finally, staples 198 in one or
more zones of the cartridge 364 between the antrum 24 and the
fundus 26 may include about 33% black staples, about 33% green
staples, and about 33% blue staples. Including staples 198 having
varying open leg lengths based on a determined probability of the
tissue thickness advantageously provides an improved likelihood
that one or more staples 198 are appropriately sized within any
given zone based on the varying tissue thickness of the stomach
10.
[0213] With reference to FIGS. 23 and 23A-23C, in one embodiment,
in which like reference numerals refer to like features throughout
the figures, the cartridge 364 includes one or more zones of
staples 198 in which the open leg lengths of the staples 198 change
according to a particular pattern in one or more directions. That
is, the staples 198 are not randomly distributed, as described
above. Rather, the staples 198 are arranged in a predetermined,
organized pattern. By way of example, the staples 198 may be
arranged to change size in a direction perpendicular to the
longitudinal axis of the cartridge 364, referred to as columns,
and/or in a direction parallel to the longitudinal axis of the
cartridge 364, referred to as rows. FIG. 23 depicts a single row of
staples 198 that may be divided into zones 1 and 2 of staples 198.
Each zone 1 and 2 may have a single predetermined open leg length
of staple 198, as shown. The predetermined pattern of the staples
198 having different open leg lengths along the rows and/or columns
of the cartridge 364 may be determined based upon the expected
closed leg length in each zone, as is described above.
[0214] With reference to FIGS. 23A and 23B, the cartridge 364 may
include four rows I, II, III, and IV of staples 198. Each row of
staples 198 within each zone may be of different open leg length
and/or gauge. For example, column A, shown in FIG. 23A, may include
staples 198 of a different gauge than the staples 198 in column B,
shown in FIG. 23B, though the open leg length of the staples 198 in
the corresponding rows of each column may be the same. Taking each
of the rows and columns shown in FIGS. 23-23B into account, each
zone with the corresponding rows and columns may be shown in FIG.
23C. Zones 1 and 2 include staples 198 of different open leg
lengths. Zones 1 and 2 also differ in the wire diameter, or gauge,
of the staples 198. By way of example, and with continued reference
to FIG. 23C, zone 1 may include rows I, II, and III of staples 198
having open leg lengths of 4 mm, 4.5 mm, and 5 mm, respectively, in
each column. Zone 2 may include rows I, II, and III of staples 198
having open leg lengths of 3 mm, 3.5 mm, and 4 mm, respectively.
The staples 198 of row IV is on the to-be-excised portion of
stomach 10 and is shown in phantom. The number and length of the
zones will vary based on the proximal and distal gaps of the end
effector as is described above. Thus, it should be realized that
aspects of the present invention are not limited to the illustrated
arrangement, where the cartridge 364 includes two zones of rows and
columns having staples 198 of different open leg lengths and/or
different gauges. Other alternative arrangements may also be
possible.
[0215] With reference to FIG. 24A, in one embodiment, a cartridge
460 may be configured to include a plurality of magazines 462 that
may be separated and reassembled. Each magazine 462 may include
three rows 464 of staples 198 and be assembled to define a channel
468 for a cutting knife (not shown). The stomach 10 is often
stapled on both sides of the cutting blade to prevent the release
of undesirable contents of the excised portion of the stomach into
the abdominal cavity. While the rows 464 on each side of the
channel 468 are specifically shown to mirror one another, it would
be readily appreciated that, in alternate embodiments, the rows 464
of staples 198 on the side of the stomach that will be excised
(anatomical left) need not mirror the rows of staples on the side
of the resultant stomach pouch (anatomical right).
[0216] With reference to FIGS. 24A, 24B, and 24C, the magazines 462
may have an interlocking feature 470 that, in the exemplary
embodiment shown, includes a projection 472 that extends outwardly
from a main body 474 of the magazine 462 and a recess 476 that
extends into the main body 474 of the magazine 462. When the
magazines 462 are assembled, the adjacent magazines 462 engage each
other through abutting contact. More particularly, the projection
472 is positioned within the recess 476 to couple adjacent
magazines 462 back-to-back. The interlock between adjacent
magazines 462 may more firmly stabilize the cartridge 460 during
use but allow the surgeon to adjust the overall length of the
cartridge 460. The interlocking feature 470 may also more easily
allow for the rows 464 to be positioned with the staples 198
staggered from each adjacent row. By way of example, without
limitation, the magazine 462 may be from about 5 mm to about 260 mm
in length. In one embodiment, the magazine 462 may be, for example,
about 60 mm in length. In this case, four magazines 462 may be used
to prepare one staple line. Each magazine 462 may include staples
198 having open leg lengths different from the staples 198 in an
adjacent or another magazine 462. Other alternative arrangements
may also be possible.
[0217] The surgeon may determine which magazine 462 to use based on
the included open staple leg lengths and the thickness of the
stomach as described above. Further, the magazines 462 may vary in
height, as shown in FIGS. 24B and 24C with one or more of the
heights H1, H2, and H3 of the magazines 462 differing from one
another. In this regard, the gap between the cartridge 460 and the
anvil (not shown) may vary along the length of the cartridge 460 in
a staggered configuration by each magazine 462. In one embodiment,
four magazines 462 from the proximal end to the distal end may
include staples 198 having an open leg length of 4.4 mm (black),
4.1 mm (green), 3.8 mm (gold), and 3.5 mm (blue), respectively.
When these magazines 462 are placed into the cartridge 460 and the
stomach 10 is compressed between the anvil (not shown) and the
cartridge 460, the gap at each of the four magazines may be 2.3 mm,
2.0 mm, 1.8 mm, and 1.5 mm, respectively. In this regard, the
surgeon may advantageously adapt the cartridge 460 depending on the
anatomy of the individual patient. Those of ordinary skill in the
art will recognize that there may be other configurations of
magazines 462 useful in embodiments of the present invention.
[0218] With reference to FIGS. 25 and 26A and 26B, in one
embodiment, a cartridge 480 includes a plurality of magazines 482
that may be elongated as compared to the magazines 462 described
above with reference to FIGS. 24A-24C. In one embodiment, each
magazine 462 may extend from the proximal end to the distal end of
the cartridge 480. Each magazine 482 may include one or more rows
of staples 198 in multiple columns. In the exemplary embodiment
shown, a separate magazine 482 defines each of rows I, II, III, and
IV with row IV having two staggered columns of staples 198. As with
the magazines 462 above, each magazine 482 may include staples 198
having different open leg lengths and/or gauges from the staples
198 in adjacent magazines 462. Further, the magazines 462 may vary
in height. In this regard, the gap between the cartridge 480 and
the anvil (not shown) may vary in the transverse direction, as
shown by comparison of FIGS. 27A and 27B. The magazines 482 may be,
for example, about 250 mm in length. The surgeon may determine
which magazines 482 to use based on the included open staple leg
lengths and personal preferences regarding the completed staple
line. In one embodiment, the surgeon may choose staples 198 having
a larger open leg length adjacent an outer edge 486 of the
cartridge 480 and staples 198 having a smaller open leg length
adjacent a knife channel 488 in the cartridge 480. In this regard,
the surgeon may advantageously adapt the cartridge 480 depending on
the anatomy of the individual patient.
[0219] With reference to FIGS. 27A-27C in which like reference
numerals refer to like features throughout the figures, in one
embodiment, a shim 490 is coupled to each of the anvil 42 and the
cartridge 44. The shims 490 increase in thickness from the first
edges 492, 494 to the second edges 496, 498 of the anvil 42 and the
cartridge 44. When the stomach 10 is compressed between the anvil
42 and the cartridge 44, the predetermined thickness of the shims
490 provides different levels of compression across the width of
the staple line 12, as is shown in FIG. 27B. In other words, the
portion of the shims 490 with a greater thickness provides more
compression. During actuation of the wedge (not shown), the staple
drivers 200 are forced toward the anvil 42, the staples 198 pierce
through the shims 490 coupled to each of the anvil 42 and the
cartridge 44 to come into contact with the staple pockets 190.
[0220] Once the stomach 10 has been stapled, the staples 198 having
the same open leg length will also have generally the same closed
leg length along the width of the staple line 12 even though the
thickness of the stomach gradually decreases toward the edge of the
staple line 12. The increased compression along the edge of the
resultant stomach pouch aids in providing hemostasis and reducing
the possibility of dehiscence. Embodiments of the present invention
are not limited to the illustrated arrangement, where both the
anvil 42 and the cartridge 44 include a shim 490. In an alternative
embodiment, for example, the shim 490 may be coupled to the anvil
42, while the cartridge 44 does not include a shim. Furthermore,
the configuration of the shim 490 may be used in conjunction with
the shim 410 show in FIGS. 13 and 14A. As a result, the thickness
of the shims may change in a direction along the longitudinal axis
of the end effector (see e.g., FIG. 13) and may also change in a
direction perpendicular to the longitudinal axis of the end
effector (see e.g., FIG. 27A).
[0221] With reference to FIGS. 28A and 28B, in which like reference
numerals refers to like features throughout the figures, in one
embodiment, a shim 500 is positioned on the face 194 of the
cartridge 44 adjacent the knife channel 488 over selected rows I
and II of staples 198. A second shim 502 is coupled to the face 192
of the anvil 42 and a location that opposes the first shim 500 on
the face 194 of the cartridge 44. Once the stomach 10 has been
stapled, the shims 500, 502 may form a portion of the staple line
12 and provide a localized increase in compression across a
selected width of the tissue in the staple line 12, as is
illustrated in FIG. 28B. Alternative arrangements may also be
possible.
[0222] With reference to FIGS. 29 and 30A, in which like reference
numerals refer to like features throughout the figures, in one
embodiment, the cartridge 44 includes rows I, II, III, V, VI, and
VII of staples 198. The staples 198 in one or more of the rows I,
II, III, and IV may have different crown lengths, different leg
lengths, and/or different wire diameters. In the exemplary
embodiment shown, rows I and II may include staples 198 having a
shorter leg length than the staples 198 in rows III and VI, as
shown in FIG. 30A. Additionally, the staples 198 in rows I and II
may have a smaller wire diameter, or gauge, than the wire diameter
of the staples 198 in rows III and VI. In this regard, the staples
198 in rows III and VI may provide relatively more mechanical
strength to the staple line 12 and the staples 198 and rows I and
II. Instead, the staples 198 of rows I and II may provide improved
hemostasis compared to the staples 198 in rows III and VI. As
discussed above, the rows of staples on the to-be-excised side of
the stomach 10 need not match or be similar to the rows of staples
198 on the side of the resultant stomach pouch. For example, rows V
and VII may include staples 198 having a similar crown length as
the staples 198 in rows III and VI. In one embodiment, the crown
length and wire diameter of the staples 198 in each of the rows I,
II, III, V, VI, and VII may vary along the length of the cartridge
44 as described above.
[0223] With reference to FIGS. 30B and 30C, in which like reference
numerals refer to like features throughout the figures, in one
embodiment, the end effector 40 includes an anvil 510 and a
cartridge 512. The anvil 510 has an anvil face 514, and the
cartridge 512 has a face 516, which opposes the face 514 of the
anvil 510. As shown, the face 514 as an irregular configuration
that does not mirror the planar surface defined by the face 516 of
the cartridge 512. In the configuration shown, the anvil 510 has a
cross-sectional configuration in which the face 514 is generally
V-shaped. In this regard, the face 514 may include two sloped
portions 518 and 520 that intersect the knife channel 488 in the
anvil 510. The gap between the anvil 510 and the cartridge 512
varies side to side, that is, between the sloped portion 518 and
the face 516 and between the sloped portion 520 and the face 516.
In the embodiment shown, each row of staples 198 in the cartridge
512 includes staples 198 having the same open leg length. By way of
example only, the gap is greater at the outside edges of the anvil
510 and the cartridge 512 than the gap adjacent edges of the knife
channel 488. Due to the angle of the sloped portions 518 and 520,
the staple pockets 190 will be separated by different distances as
compared to an anvil face that is parallel to the face of a
cartridge (for example, as shown in FIG. 6A). Further, the spacing
of the staple pockets 190 between the sloped portion 518 may differ
from the spacing of the staple pockets 190 of the sloped portion
520. More specifically, the angle of the sloped portion 518
relative to the cartridge 512 may be used to determine the location
of each staple pocket 190 in the slope portion 518. The same
determination may be made with respect to the sloped portion 520.
By way of example only, and not limitation, the anvil 510 may be
about 2.5 mm wide and may be spaced about 1.0 mm from the cartridge
512 adjacent the knife channel 488 and about 1.4 mm at the edge of
the anvil 510. In this embodiment, the angle of the sloped portions
518 and 520 may each be about 10.8 degrees off parallel with
respect to the face 516. Where the cartridge 512 has rows I, II,
and III of staples 198 that are spaced about 1.25 mm apart, the
corresponding rows of pockets 190 in the sloped portion 518 may be
spaced about 1.27 mm apart from the row II and may be spaced 2.55
mm apart from the row III.
[0224] During activation of the end effector 40, the wedges (not
shown) push the staple drivers 200 and the staples 198 toward the
anvil 510. Where the same wedge (not shown) forces the staples 198
toward the anvil 510, the staples 198 in row I contact the staple
pockets 190 before the staples 198 in rows II and III because of
the shorter distance to the sloped portion 518 proximate row I. The
staples 198 in row II contact the staple pockets 190 in the face
514 before the staples 198 in row III for the same reason.
[0225] Once the stomach 10 has been stapled, the staples 198 having
the same open leg length may have different closed leg lengths
along the width of the staple line, as is illustrated in FIG. 30C.
In this regard, the staples 198 in row I may have a smaller closed
leg length compared to the staples 198 in rows II and III.
Similarly, the staples 198 in row III may have a larger closed leg
length than the staples 198 in rows I and II. In this
configuration, the compression provided by the end effector 40 and
difference in closed leg length of the staples 198 across the width
of the staple line 12 may improve the integrity of the staple line
12.
[0226] In the exemplary embodiment shown in FIG. 31, in which like
reference numerals refer to like features throughout the figures,
an end effector 570 includes an anvil 572, a cartridge 574, and an
alignment mechanism 576 that aids in alignment of the anvil 572
with the cartridge 574 and further aids in providing uniform
compression of the tissue between the anvil 572 and the cartridge
574. A guide slot 578 extends through the cartridge 574 and opens
to the cartridge face 194. A guide channel 580 extends axially
through the cartridge 574. The guide slot 578 opens to the guide
channel 580. The anvil 572 includes a guide slot 582 that opens to
an anvil guide channel 584 and opens to the face 192.
[0227] In one embodiment, the alignment mechanism 576 includes a
knife 590 that has an I-shaped cross sectional configuration, much
like an I-beam. The knife 590 has a top flange 592, a bottom flange
594, and a web 596 connecting the top flange 592 to the bottom
flange 594. The top flange 592 slidably engages the guide channel
580 of the anvil 572 and the bottom flange 594 slidably engages the
guide channel 580 of the cartridge 574. This configuration improves
the rigidity of the end effector 570 during stapling/cutting. The
I-beam configuration may substantially prevent any torque produced
by the stapling/cutting action from twisting the anvil 572 relative
to the cartridge 574 as can be appreciated by the cross-section
shown in FIG. 31 in which the knife 590 is shown to positively lock
the anvil 572 relative to the cartridge 574 and thereby prevent
their separation and relative side-to-side motion during
cutting/stapling. Other configurations are possible.
[0228] In an alternate embodiment, and with reference to FIG. 32,
the knife 590 may have a Y-shaped top flange 600. In this
embodiment where the anvil face 192 is not parallel to the
cartridge face 194 in the transverse direction, the Y-shaped top
flange 600 may provide improved alignment within a complimentarily
shaped guide channel 584. Alignment mechanisms are further
described further described in the commonly-owned International
Application No. PCT/US2015/022904, which is incorporated by
reference herein in its entirety.
[0229] When the anatomical structure is being compressed by the
anvil and the cartridge, the compression should be great enough to
stop the flow of blood to the area to be stapled and/or cut. At the
same time, the anatomical structure should be compressed to create
a desired gap between the anvil and the cartridge to achieve a
B-shaped staple configuration along the staple line 12. Once a
staple is formed in the B-shaped configuration, the configuration
resists changes to the formed height. Accordingly, it is important
to provide sufficient compression along the length of the end
effector, which becomes more challenging as the length of the end
effector increases. Conventional end effectors do not address the
issue of providing sufficient compression along an end effector
where the tissue thickness varies over the length of the anatomical
structure being stapled while also providing the desired gap for
achieving a B-shaped staple.
[0230] In one embodiment, and with reference now to FIGS. 33-36,
the changing gap between the anvil and the cartridge, as is
described above in for example FIG. 11, may affect the track
defined by the guide channels 580 and 584 of the alignment
mechanism 576. In an aspect of the present invention, adjusting the
configuration of the anvil face and/or the cartridge face to
compensate for the decrease in tissue thickness from the antrum 24
to the fundus 26 may allow for uniform compression and B-shaped
staple formation along the length of the end effector. In FIG. 33,
the cartridge face 194 is not parallel to the anvil face 192.
However, the guide channel 584 is parallel to the anvil face 192.
The orientation of the guide channel 580 may be angled to extend
through the cartridge 574 at an angle that is nearly equivalent to
but oppositely oriented from the angle between the cartridge face
194 and the anvil face 192. With this configuration, the track of
the knife 590 is the same along the end effector 570. The gap
between the anvil 572 and the cartridge 574 changes as described
above with reference to FIG. 11. In this regard, the angled
cartridge face 194 may compensate for the angled thickness of the
stomach 10 while sufficient compression and B-shaped staple
formation is maintained along the length of the end effector 570.
The cartridge 574 may be a unitary body, the angled cartridge face
194 being an integral part of the unitary body. Alternatively, a
separate element (e.g., a shim) may be coupled to the cartridge 574
to result in the angled configuration.
[0231] In one embodiment, and with reference to FIG. 34, in which
like reference numerals refer to like elements throughout the
figures, the anvil face 192 is angled relative to the cartridge
face 194, while the guide channel 584 of the anvil 572 is generally
parallel to the cartridge face 194. As shown, the guide channel 584
is oriented at an angle relative to the anvil face 192 so that the
track for the knife 590 is constant. In this regard, the angled
anvil face 192 may compensate for the angled thickness of the
stomach 10 while sufficient compression is maintained along the
length of the end effector 570. The anvil 572 may be a unitary
body, the angled anvil face 192 being an integral part of the
unitary body. Alternatively, a separate element (e.g., a shim) may
be coupled to the anvil 572 to result in the angled
configuration.
[0232] In one embodiment, and with reference to FIG. 35, in which
like reference numerals refer to like elements throughout the
figures, the guide channels 580 and 584 are parallel to each other
but are each angled relative to the faces 192, 194. In FIG. 36, the
cartridge face 194 includes a stepped configuration similar to the
shown in, for example, FIG. 15A. The guide channels 580 and 584 are
parallel to one another. In this regard, the stepped configuration
of the cartridge face 194 may compensate for the angled thickness
of the stomach 10 while sufficient compression and B-shaped staple
formation is maintained along the length of the end effector 570.
The cartridge 574 may be a unitary body, the stepped cartridge face
194 being an integral part of the unitary body. Alternatively, a
separate element (e.g., a shim) may be coupled to the cartridge 574
to result in the stepped configuration.
[0233] FIGS. 37A-40B each illustrate shapes of staples 198 and
shapes of staple pockets 190. In FIGS. 37A and 37B, a B-shaped
staple is shown. To shape the staples 198 into a conventional B
shape, the tips of the staple legs may be bent past the crown. It
will be appreciated that this shape may result from deformation
caused by forcing a staple 198 into the staple pockets 190 shown in
FIGS. 39A and 39B. Staple pockets include paired staple leg
receiving cups that are mirror images in the anvil face. In FIGS.
38A and 38B, a "2-D"-shaped staple 198 is shown. This 2-D
configuration may be advantageous where staples 198 having the same
open leg length are configured to have different closed leg
lengths. This configuration may be produced with the staple pocket
190 shown in FIGS. 40A and 40B. If the tips of the staple legs are
bent so that they extend past the crown, there is a possibility the
tips may snag or puncture tissue near the stomach. To prevent this,
the staple pockets 190 can be configured to allow for the arc
segment of the bent staple legs to have a wider radius. More
specifically, the longitudinal portion of the staple pockets 190 is
created by two intersecting arcs. The first arc has a radius of
about 0.040 inch to about 0.060 inch that is cut to a depth of
0.010 inch to 0.030 inch. A second arc is has a radius of about
0.030 inch to about 0.050 inch. At the center of the staple pockets
190, the first and second arcs intersect. The distance between the
two paired cups is from about one times the radius of the staple
wire to about two times the radius of the stapler wire. The
transverse shape of the 2-D pocket is created by parabolic arcs
that intersect with the longitudinal arcs to create a rectangular
shaped cut into the surface of the pocket. The rectangular-shaped
cut is about four times to about six times the diameter of the
staple wire and the length is about half of the radius to about one
times the radius of the span of the crown of the staple. Pocket
shapes according to embodiments of the present invention may be
sized for staples having any crown length, wire diameter, and leg
length. In this manner, the bent tips will not cross the midline of
the crowns of the staples 198. In one embodiment, and with
reference to FIGS. 38A and 38B where there is a gap increase
between the anvil and the cartridge in the transverse plane
(transverse to the longitudinal direction), both of the leading
(distal) and lagging (proximal) staple legs will be deflected to
the same side of the crown (shown in FIG. 38B). Consequently, the
legs of the staples 198 may cross.
[0234] In embodiments of the end effector, where there is a gap
increase between the anvil and the cartridge, for example, like
that shown in FIG. 11, the leading leg of each staple 198 will
contact the leading pocket and begin bending before the lagging leg
contacts the lagging pocket when the surgeon fires the stapling
mechanism. With reference to FIGS. 39A-40B, the staple pockets 190
may be configured to bend the leading leg so that it is out of the
way of the lagging leg when the lagging leg crosses the leading
leg. In this manner, the trajectory of the bent second leg is not
interrupted by collision with the already bent leading leg. Those
of ordinary skill in the art will recognize that other alternative
arrangements may also be possible to prevent the tips of the staple
legs from crossing below the staple crowns.
[0235] As discussed above, the portion of the stomach being
resected is often stapled along with the stomach sleeve to prevent
undesirable leakage of contents therefrom. With reference to FIG.
41, an exemplary embodiment includes the endocutter stapling device
100 described above with reference to FIG. 3 and a clamp 610.
Before actuation of the endocutter stapling device 100, the clamp
610 may be clamped onto the tissue adjacent the endocutter stapling
device 100 that will be excised after the staple line is complete.
In other words, the clamp 610 may be to the anatomical left of the
endocutter stapling device 100. With this configuration, stapling
the to-be-excised portion of the stomach 10 would not be necessary
due to the compression provided by the clamp 610. In this regard,
the endocutter stapling device 100 may be configured to only staple
the tissue that will become the stomach sleeve. The clamping force
provided by the clamp 610 may supplement the clamping force
provided by the endocutter stapling device 100. This additional
compression near the cut line may result in an improved staple
line. After the staple line is complete, the excised portion would
still be clamped by the clamp 610, as shown in FIG. 41.
[0236] In one embodiment of the present invention, with reference
to FIG. 42, a spacer 620 may be coupled to the anvil 42 of the
endocutter stapling device 100. The spacer may have a width of, for
example, about 1 cm. The staple line 12 is frequently 1 cm away
from the gastro esophageal junction 22, and using the spacer 620 to
space the endocutter stapling device 100 apart from the gastro
esophageal junction 22 would assure a proper spacing from this
anatomical landmark. Properly spacing the endocutter stapling
device 100 from the gastro esophageal junction 22 ensures that
staples are not formed on a part of the esophagus. While the spacer
620 is specifically shown as being coupled to the anvil 42, it
would be readily appreciated that in alternate embodiments, the
spacer 620 may alternatively or additionally be coupled to the
cartridge 44.
[0237] While the present invention has been illustrated by a
description of various preferred embodiments and while these
embodiments have been described in some detail, it is not the
intention of the inventor to restrict or in any way limit the scope
of the appended claims to such detail. Further, it should be
recognized that the spacing and scale of certain elements depicted
in the Figures may be exaggerated to aid in the understanding of
the present invention. Consequently, the Figures may be seen as
schematic representations rather than exact representations of
embodiments. Though the embodiments described herein were primarily
directed to a stapler, it is clear that many of the aspects of the
present invention may be utilized with additional devices. By way
of example, the embodiments described herein may operate as a
surgical clamp or a stabilizing device independent of the aspects
of the present invention that allow the embodiments to act as a
stapler. Additional advantages and modifications will readily
appear to those skilled in the art. The various features of the
invention may be used alone or in any combination depending on the
needs and preferences of the user.
* * * * *