Engineering a Better
Grip on Movement
The least tissue slippage
during firing
Technology Overview
Viscoelastic nature of soft tissue and
its effects on proper staple formation
The basics of staple formation involve a sled advancing forward and
pushing staple drivers up, driving unformed staples into anvil pockets
in order to produce properly formed, B-shape staples. In nominal
tissue thicknesses, the cartridge and the anvil are parallel, allowing
for staple legs to consistently hit the anvil pockets, delivering proper
staple formation.
However, there can be challenges involved with attaining proper staple
formation as tissue thickness increases, regardless of which reload
is being used. Surgical staplers apply significant compressive force
in a linear fashion, proximal to distal, to prepare tissue for stapling.
Because human tissues are comprised largely of fluid, they exhibit
time-dependant viscoelastic qualities in response to compressive
forces. As a result, they tend to take the path of least resistance when
compressive forces are applied, leading to tissue movement or slippage.
For optimal stapling formation in a range of situations, it is critical that
tissues are relatively free of motion during the stapling process and
that alignment between the cartridge channel and anvil is maintained
during firing. Understanding and accounting for tissue characteristics
in device design, and by utilizing alternate techniques during use of the
device, mitigates the effects of tissue thickness and density as well as
tissue slippage.
Challenging tissues can create
staple misalignment during firing
As the knife blade advances during firing, tissue slippage can
push staple legs proximally and laterally as they are ejected
from the staple pockets. If the tissue slippage is great enough,
the trajectory of the staple legs can be altered creating a
misalignment with the anvil pockets. Misalignment of the staple
legs with anvil pockets can also result from deflection of the
cartridge channel and/or anvil as a result of high loads placed
on the stapling system, especially in thicker tissue firings.
Deflection of the cartridge channel and anvil occurs when
the knife blade that is part of the E-Beam/I-Beam advances
to deliver focal-point compression during transection of the
tissue. The E-beam pulls the cartridge channel and anvil
together, creating increased loads and forcing tissue and fluids
to push longitudinally and laterally in the end effector. This can
lead to the anvil bending up slightly distal to the knife blade
advancement while the cartridge channel or deck may flex
or bow outward because of the opening along the bottom,
commonly known as the knife slot.
Increased loads in challenging tissue will result in tissue slippage and may
cause the anvil to deflect, increasing the potential for misalignment.
Advancement of compressive element in challenging tissue can result in high
forces that may deform or bow the reload and reload channel.
Inefficient tissue transections
While tissue slippage may not always have an adverse effect on staple formation, it still occurs and can be observed to push or milk tissue
out the end of the stapler. This may lead to costly and time-consuming additional firings to complete the intended tissue transections.
Tissue milking out of the end of the gun as a result of tissue slippage along the entire length of the firing.
A better grip on movement
The ECHELON FLEX GST System* is uniquely designed for stronger grip†
to provide the least tissue slippage of any leading endocutter‡ delivering:
• 4x less tissue slippage during firing compared to Endo GIA™ Reloads
with Tri-Staple™ Technology§ for unsurpassed staple performance
– May eliminate 1 reload per procedure‡ and delivers a more targeted
tissue transection with each firing.¶
• Only portfolio of reloads to provide uniform closed staple heights and
reliable staple formation across a range of tissue thicknesses with each
reload.\\
• Only reloads with Gripping Surface Technology have a proprietary ridged
surface to grip and hold tissue during firing with no additional tissue
trauma.**
The stability of a powered firing—88% less movement at the end
effector†† for potentially less trauma to adjacent tissues.
Design elements for performance
Reloads made to grip
A better staple
As part of the ECHELON FLEX GST System, the design innovation of
the ENDOPATH ECHELON Reloads with Gripping Surface Technology
first provides a more secure hold on tissue† to minimize tissue slippage
during firing.‡ The superior hold may eliminate a reload during a case‡
because of the more targeted tissue transection. Up to an average of
5.9mm more tissue transected is delivered with each firing.‡‡ In addition,
the gripping surface extensions hold and support staple legs as they
are advanced through tissue and into the anvil pockets.
During firing, tissue slippage can push
staples off course, but the new reloads
with GST minimize these effects with
an innovative staple design.
Conventional
unformed staple
Asymmetrical, bent
tip unformed staple
• Bent staple tips mitigate the slight
change in trajectory of the staples
that may occur due to tissue slippage, allowing them to hit the anvil
pockets for consistent staple formation.
• Asymmetrical staple legs further compensate for tissue slippage
effects on each staple leg with a slightly increased bent staple tip on
the distal leg.
A powered stapler optimized for high tissue loads
Endocutters that utilize an open cartridge channel design may be less
readily equipped to handle the stresses produced by thick or dense
tissue firings, resulting in the staple legs misaligning with anvil pockets.
This can lead to improperly formed staples.
Flat Reload Surface
Reloads with Gripping Surface
Technology
Only the ECHELON FLEX Powered Plus Stapler has a closed bottom
channel to provide a rigid foundation that can withstand the high loads
and stresses encountered in thick tissue firings. This design reduces
lateral deflection or movement—essential for thicker tissue firings where
system loads can create deflection of the cartridge channel.
Design elements for performance
Powered stapling with optimal compression
The ECHELON FLEX GST System is built upon the stability of a powered firing and
uniform compression with 3-point gap control. The 3-point gap control mechanism of the
ECHELON FLEX Platform ensures a uniform distance between the anvil and cartridge
surfaces during firing to provide reliable uniform closed staple heights along the length of
the transecton. This is achieved by maintaining 3 separate points of alignment as the knife
travels from the proximal end to the distal tip.
Performance verification
Extensive benchtop testing evaluating the effects of pocket extensions, staple geometry and closed bottom
channel have been performed to verify the ECHELON FLEX™ GST System’s performance.
Grip testing
One of the keys to reducing the tissue movement that can be so detrimental to stapling outcomes is to achieve
a strong grip on tissue. To assess the superior grip provided by the ECHELON FLEX GST System, a benchtop
engineering study evaluated the system’s ability to withstand longitudinal loads applied to tissue grasped by the jaws
of the device. Testing measured the amount of force required to remove porcine stomach tissue from the jaws of
the ECHELON FLEX GST System and Endo GIA ULTRA Handles and Endo GIA Reloads with Tri-Staple Technology
devices in 1.5mm (GST Blue & Tri-Staple Purple) and 2.3mm (GST Black & Tri-Staple Black) tissue. Tissue thickness was
measured with a Tissue Measuring Device (TMD) applying a force of 8g/mm2.
The ECHELON FLEX Powered Plus Stapler and ENDOPATH ECHELON Reloads with GST are uniquely designed for
better grip to provide the least tissue slippage of any leading endocutter‡ for unsurpassed stapling performance.
The ECHELON FLEX GST System provides
at least 4x the gripping strength compared
to the Endo GIA ULTRA Handle and
Reloads with Tri-Staple Technology.
Boxplot of Tissue Grasping Force
12
PEAK LOAD (lbf)
10
8
7.527
6.067
6
4
2
1.859
1.157
0
Tri-Staple
Purple @ 1.5
GST
Blue @ 1.5
Tri-Staple
Black @ 2.3
GST
Black @ 2.3
The boxplot describes the median, interquartile range, range and outliers for each group.
Performance verification
Tissue slippage testing
To compare the performance of the ECHELON FLEX GST System to that of Endo
GIA Reloads with Tri-Staple Technology, both devices were clamped and fired on
porcine stomach tissue, measured with a TMD applying a force of 8g/mm2, ranging
from 1.5 – 4.0mm in thickness.
• GST Blue reloads were compared to Tri-Staple Purple reloads in 1.5mm tissue.
The Least
Least Tissue
Tissue Milking
MilkingDuring
DuringFiring
Firing
§§
AFTER FIRING
5.1mm
.65mm
BEFORE FIRING
• GST Green reloads were compared to Tri-Staple Purple reloads in 2.5mm tissue.
Tissue was marked to provide multiple reference points along the length. Tissue
movement was captured optically via a digital camera tracking these reference points. Movement in the digital video footage was measured and evaluated electronically
utilizing proprietary software to calculate actual mm of tissue movement during firing.
The ECHELON FLEX GST System minimizes tissue milking during firing‡ and
provides a more exact tissue transection for more targeted tissue transected
with each firing.¶
‡
Less Tissue
Less
TissueMilking
Milking*
Across aaRange
Thicknesses
Across
RangeofofTissue
Tissue
Thicknesses
2.5
mm
3.3 m
m
4.0
m
• GST Black reloads were compared to Tri-Staple Black reloads in 4.0mm tissue.
ECHELON
FLEX™
GST System
Endo GIA™
Reloads with
Tri-Staple™
Technology
6.0
mm
1. 5 m
• GST Black reloads were compared to Tri-Staple Purple reloads in 3.3mm tissue.
4.5
3.0
1.5
TISSUE SLIPPAGE
(mm per firing)
Endo GIA™ Reloads
with Tri-Staple™
Technology
1.5
3.0
4.5
6.0
TISSUE SLIPPAGE
(mm per firing)
ECHELON FLEX™
GST System
Performance verification
Staple line integrity
The ultimate goal in any surgical stapling scenario is a proper
staple formation to a specified closed staple height for optimal
staple line integrity. Under challenging conditions, proper staple
formation becomes more difficult to achieve, and staple line
integrity may be compromised.
RELOAD
CLOSED
STAPLE HEIGHT
TISSUE
THICKNESS RANGE
AcrossaaaRange
Rangeof
ofTissue
TissueThicknesses
Thicknesses
Across
Across
Range
of
Tissue
Thicknesses
THICKEST
THICKESTTISSUE
TISSUE
4.0
4.0
PORCINE
(mm)
PORCINE TISSUE
TISSUE THICKNESS
THICKNESS (mm)
2
measured
at
8g/mm
prior
to
firing
2
measured at 8g/mm prior to firing
The ECHELON FLEX GST System is designed to meet strict
performance requirements around staple formation and staple line
quality. Both of these measures were evaluated at different tissue
thicknesses, which were comfortably compressed to the related
closed staple height, to ensure these innovative enhancements
reliably deliver on design requirements. Minimizing tissue slippage
and the deflection of the deck and anvil allows the ECHELON FLEX
GST System to deliver the same closed staple height of the current
ECHELON ENDOPATH™ Reloads and allows for reliable staple
performance across a range of tissue thicknesses across each reload.
ReliableStaple
Staple
Formation Reliable
Reliable
Staple
Formation
Formation
3.5
3.5
3.0
3.0
2.5
2.5
2.3mm
2.3mm
_________
_________
2.0
2.0
1.8mm
1.8mm
_________
_________
GST60T
GST60T
1.5mm
1.5mm
_________
_________
1.5
1.5
1.0
1.0
2.0mm
2.0mm
_________
_________
BLACK
BLACK
GST60G
GST60G
GREEN
GREEN
GST60D
GST60D
1.0mm
1.0mm
_________
_________
GOLD
GOLD
GST60B
GST60B
BLUE
BLUE
.5
.5
GST60W
GST60W
WHITE
WHITE
THINNEST
THINNESTTISSUE
TISSUE
00
White – GST60W
1.0mm
1.0 - 2.0mm
Blue – GST60B
1.5mm
1.5 - 2.4mm
Tissue
Tissuecomfortably
comfortablycompressed
compressedto
toclosed
closedstaple
stapleheights
heights
across
acrossaarange
rangeof
oftissue
tissuethicknesses.
thicknesses.
©2014
©2014Ethicon,
Ethicon,Inc.
Inc.All
Allrights
rightsreserved.
reserved.020295-140820
020295-140820
Gold – GST60D
1.8mm
1.8 - 3.0mm
Green – GST60G
2.0mm
2.0 - 3.3mm
Black – GST60T
2.3mm
2.3 - 4.0mm
Contact your ETHICON Sales Professional or visit
www.ethicon.com/gst to learn more about the performance
of the ECHELON FLEX™ Powered Plus Stapler and ENDOPATH
ECHELON™ Reloads with Gripping Surface Technology.
For complete product details, see Instructions for Use.
* S
ystem components include ECHELON FLEX™ Powered Plus Stapler and ENDOPATH
ECHELON™ Reloads with Gripping Surface Technology.
† B
enchtop testing in porcine stomach tissue. Mean peak load required to pull tissue
from the clamped jaws of ECHELON FLEX Powered Plus Stapler (PSEE60A) and
ECHELON Reload with GST vs ENDO GIA ULTRA Handle (EGIAUSTND) and Endo GIA
Reload with Tri-Staple Technology (GST60B 6.496lbf & GST60T 7.789lbf vs
EGIA60AMT 1.325lbf & EGIA60AXT 1.920lbf, all p<0.001).
‡ Benchtop testing in porcine stomach tissue. Mean tissue movement from after
clamping on tissue to after firing ECHELON FLEX Powered Plus Stapler (PSEE60A)
and ECHELON Reload with GST vs ENDO GIA™ ULTRA Handle (EGIAUSTND) and
Endo GIA™ Reload with Tri-Staple™ Technology at 1.5, 2.5, 3.3 and 4.0mm tissue
thicknesses (1.5mm; GST60B 1.067mm vs EGIA60AMT 2.452mm p<0.001; 2.5mm:
GST60G 1.148mm vs EGIA60AMT 3.261mm p<0.001; 3.3mm: GST60T 0.642mm vs
EGIA60AMT 4.806mm p<0.001; 4.0mm: GST60T 0.654mm vs EGIA60AXT 5.116mm
p<0.001).
§ B
enchtop testing in porcine stomach tissue. Mean tissue movement from after
clamping on tissue to after firing ECHELON FLEX™ Powered Plus Stapler (PSEE60A)
and ECHELON Reload with GST vs ENDO GIA™ ULTRA Handle (EGIAUSTND) and
Endo GIA™ Reload with Tri-Staple™ Technology at 3.3 and 4.0mm tissue thicknesses
(3.3mm: GST60T 0.642mm vs EGIA60AMT 4.806mm p<0.001; 4.0mm: GST60T
0.654mm vs EGIA60AXT 5.116mm p<0.001).
¶ B
enchtop testing in porcine stomach tissue. Mean tissue movement from before
clamping on tissue to release of tissue after firing ECHELON FLEX™ Powered Plus
Stapler (PSEE60A) and ECHELON Reload with GST vs ENDO GIA™ ULTRA Handle
(EGIAUSTND) and Endo GIA™ Reload with Tri-Staple™ Technology at 1.5, 2.5, 3.3 and
4.0mm tissue thicknesses (1.5mm; GST60B 2.835mm vs EGIA60AMT 2.369mm NS;
2.5mm: GST60G 2.864mm vs EGIA60AMT 3.273mm p<0.001; 3.3mm: GST60T
0.897mm vs EGIA60AMT 6.814mm p<0.001; 4.0mm: GST60T 1.415mm vs
EGIA60AXT 4.616mm p<0.001).
\\ P
orcine tissue thickness measured at 8g/mm2 prior to firing. Tissue comfortably
compressed to closed staple height per IFU.
** B
ased on 10-15 second clamp and release testing on animate preclinical lung and
vasculature. Visual comparisons of 40 paired clampings immediately following, and
1hr after clamping.
†† B
enchtop testing on porcine stomach tissue. Surgeons (n=19) fired each instrument/
reload once: PSE60A/ ECR60G, 030449/ 030459, and EGIAUSTND/ EGIA60AMT.
Median reduction of distal tip motion was 88%, range of reduction was 71% to 95%.
Benchtop testing on porcine stomach tissue. Surgeons (n=19) fired each instrument/
reload once: PSE60A/ ECR60G, 030449/ 030459, and EGIAUSTND/ EGIA60AMT.
Median reduction of distal tip motion was 88%, range of reduction was
71% to 95%.
‡‡ B
enchtop testing in porcine stomach tissue. Mean tissue movement from before
clamping on tissue to release of tissue after firing ECHELON FLEX™ Powered Plus
Stapler (PSEE60A) and ECHELON Reload with GST vs ENDO GIA™ ULTRA Handle
(EGIAUSTND) and Endo GIA™ Reload with Tri-Staple™ Technology at 3.3mm tissue
thickness (GST60T 0.897mm vs EGI60AMT 6.814mm p<0.001).
§§ B
enchtop testing in porcine stomach tissue. Mean tissue movement from after
clamping on tissue to after firing ECHELON FLEX™ Powered Plus Stapler (PSEE60A)
and ECHELON Reload with GST vs ENDO GIA™ ULTRA Handle (EGIAUSTND) and
Endo GIA™ Reload with Tri-Staple™ Technology at 4.0mm tissue thickness (GST60T
0.654mm vs EGIA60AXT 5.116mm p<0.001).
Ethicon, Inc.
www.ethicon.com
©2015 Ethicon Endo-Surgery, Inc. All rights reserved. 030482-150302
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