The plastic safety on the handle is designed to prevent
premature stent deployment and may remain on the
device until the device is correctly positioned relative to
the treatment site.
Lubricate the distal portion of the stent delivery catheter
with water-soluble lubricant to aid in introduction. Back-
load the guide wire into the distal end of the delivery
system.
7. Positioning of ALIMAXX-ES™ Esophageal Stent
in Esophagus.
7.1 Under endoscopic visualization,
advance the
ALIMAXX-ES™ Esophageal Stent System over the guide
wire through the stenosis. Stent positioning can be
accomplished using fluoroscopy and/or endoscopy.
7.1.1 For stent placement across the GE Junction
using endoscopy,
advance the delivery catheter 25mm
across the GE Junction and into the stomach to ensure
engagement of the anti-migration features of the
deployed stent at the GE Junction. Use endoscopy to
visualize the green marker located on the catheter inner
shaft at the proximal end of the stent. Ensure the distal
end of the green marker is at least 25mm proximal to the
proximal end of the stenosis.
When using fluoroscopy, visualize the radiopaque
markers on the delivery system tip and inner shaft. Align
the proximal end of the radiopaque tip 25mm across the
GE junction and into the stomach. Ensure the distal end
of the proximal marker is at least 25mm proximal to the
proximal end of the stenosis.
Continue to step 7.2 for further instructions.
7.1.2 For stent placement to treat a STRICTURE near
the upper esophageal sphincter using endoscopy,
visualize the green marker located on the catheter inner
shaft at the proximal end of the stent. Align the distal end
of the green marker 25mm proximal to the proximal end
of the stenosis.
When using fluoroscopy, visualize the radiopaque
markers on the delivery system tip and inner shaft. Align
the radiopaque marker located at the proximal end of the
stent 25mm proximal to the proximal end of the stenosis
and the tip marker at least 25mm distal to the stenosis.
Continue to step 7.2 for further instructions.
7.1.3 For stent placement to treat fistulas NOT
INVOLVING A STRICTURE near the upper esophageal
sphincter using endoscopy,
visualize the green marker
located on the catheter inner shaft at the proximal end of
the stent. Align the distal end of the green marker at least
20mm distal to the upper esophageal sphincter which
indicates the desired location for the most proximal end
of the stent allowing adequate margin from the upper
esophageal sphincter.
When using fluoroscopy, visualize the radiopaque
markers on the delivery system tip and inner shaft. Align
the radiopaque marker located at the proximal end of
the stent at least 20mm distal to the upper esophageal
sphincter which indicates the desired location for the
most proximal end of the stent allowing adequate margin
from the upper esophageal sphincter. The tip marker
should be positioned distal to the fistula.
Continue to step 7.2 for further instructions.
7.1.4 For all other stent placement locations,
use
endoscopy to visualize the green marker located on the
catheter inner shaft at the proximal end of the stent. Align
the distal end of the green marker 25mm proximal to the
proximal end of the stenosis.
When using fluoroscopy, visualize the radiopaque
markers on the delivery system tip and inner shaft. Align
the radiopaque marker located at the proximal end of the
stent 25mm proximal to the proximal end of the stenosis
and the tip marker 25mm distal to the stenosis.
7.2
Remove the plastic safety from the handle by pulling
the tab on the proximal end, taking care not to reposition
the stent.
8. Deployment of stents
The delivery system has a handle with two deployment
triggers to allow the user to deploy the stent in two steps
(Fig 1.).
Figure 1.
Hold the handle grip in the palm of your hand (Fig. 2).
Using the index and middle finger, grasp the first
deployment trigger.
Figure 2.
Slowly retract the outer sheath by pulling back on the first
deployment trigger until the deployment trigger touches
the handle (Fig 3.). The stent is now partially deployed.
The stent is not reconstrainable, however, the stent may
be repositioned proximally while holding the position of
the deployment trigger and moving the delivery system
as a unit. The stent may be repositioned proximally until
it has been deployed to approximately 50% of its length.
Figure 3.
After confirming the position of the stent use your index
and middle finger to grasp the second deployment
trigger (Fig 4.)
Figure 4.
Pull the second deployment trigger until the trigger
touches the handle (Fig 5). The stent is now fully deployed.
Carefully remove the delivery system without disturbing
the position of the stent.
Figure 5.
Warning:
Bending of the catheter directly distal to the second
deployment trigger may cause deployment problems
due to binding of the catheter (Fig. 6).
Figure 6.
It is recommended that the first 2” of the catheter distal
to the second deployment trigger remain straight to
facilitate proper stent deployment (Fig. 7).
Figure 7.
9. Assess Deployed Stent and Remove Delivery System.
Confirm endoscopically and fluoroscopically that the
stent has completely deployed and expanded. Carefully
remove the delivery catheter from within the expanded
stent, using care not to move the stent with the distal
tip of the delivery catheter. Dilation is not recommeded.
If the stent does not expand sufficiently or is not in the
desired position, the stent may be removed as described
below. Re-evaluate the size of the esophagus and choose
an appropriate size device. Repeat stent implant with a
new device.
REPOSITIONING OF THE ESOPHAGEAL STENT
The MERIT ENDOTEK™ AL
IMAXX-ES™
Esophageal Stent
design allows for repositioning of the stent proximally
immediately after placement. Conservative medical
practice suggests that stents not be repositioned
distally. The repositioning of the stent may be necessary
in the event that the stent is not in a desirable location
or improperly sized. Position the endoscope so that the
suture knot at the proximal end of the stent is visible.
The AL
IMAXX-ES™
Esophageal Stent can be repositioned
proximally using rat tooth grasping forceps to grasp the
suture knot at the proximal end of the stent and carefully
applying traction (Fig. 8).
