Allurion Elipse Mode D'emploi page 8

Figure 13: Stopcock Positions for Balloon Detachment
5.3. Confirm Balloon filling and position in the stomach
by ultrasound and/or abdominal x-ray and/or
fluoroscopy. The Catheter should remain attached
to the Balloon while confirming x-ray is obtained.
The radiopaque Catheter aids in locating the
filled Balloon.
5.4. Gently but quickly withdraw Delivery Catheter from
the mouth. The Catheter distal end will separate
from Balloon Fill Valve. To avoid catheter snapping,
use a hand-over-hand technique while removing the
Catheter. Gripping the catheter close to the mouth
prevents the Catheter from overstretching.
Warning: Do not detach Balloon from Delivery
Catheter until complete Balloon filling is confirmed.
Incomplete Balloon filling may increase the risk of
unplanned migration and/or pyloric or intestinal
obstruction.
Warning: Do not withdraw Delivery Catheter using
high force. Movement against resistance may result
in patient injury or Balloon damage.
5.5. After Balloon detachment and Delivery Catheter
removal from the patient, visually inspect the
Delivery Catheter for damage. If damage is found,
inspect for leaks by occluding the distal end of the
catheter, filling the included syringe with tap water,
connecting the syringe to the catheter hub, and
manually compressing the syringe plunger. If leaks
are observed, the balloon must be removed
endoscopically per step 6.
6. Endoscopic Elipse Balloon Removal
If required, the Elipse Balloon can be punctured
endoscopically, aspirated, and extracted from the stomach.
This endoscopic procedure should be performed under
general anesthesia after endotracheal intubation.
Other considerations related to endoscopic Elipse Balloon
needle aspiration and removal:
If a patient presents with, or reports abdominal pain/
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discomfort, nausea, vomiting, and/or abdominal
distention more than a week after balloon insertion,
consider obtaining an abdominal x-ray with the patient
standing upright. During normal filling a variable amount
of air can enter the Balloon. Hyperinflation should be
suspected if a significant amount of gas is detected
on imaging.
o Regardless of balloon volume, physicians must
use their best clinical judgment when deciding
to either intervene or monitor closely.
o In the event of spontaneous hyperinflation, it is
recommended that the balloon be punctured,
aspirated, and then removed endoscopically.
In the event of gastric outlet obstruction, the balloon
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needs to be urgently removed endoscopically.
If the Balloon is still inflated in the stomach after 20 weeks
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residence time, it should be punctured endoscopically,
and the fluid should be aspirated completely. The collapsed
Balloon should either be removed or allowed to pass
naturally.
Elipse Balloon needle aspiration and removal is preferably
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performed after intubation using general anesthesia to
minimize the risk of pulmonary aspiration. This approach
also eliminates the risk of Balloon aspiration in case the
Balloon inadvertently detaches from the grasper/forceps
in the upper esophagus during endoscopic removal.
6.1 The preferred technique is to aspirate the fluid inside
the Balloon completely and extract the collapsed
Balloon through the mouth using a dedicated
puncture/aspiration needle and two-pronged grasper
developed specifically for endoscopically placed
balloons (e.g. Prince Medical Punc Needle and
Viper Extractor).
Any of the dedicated needles and graspers for
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intragastric balloons may be used, however
a variceal injection needle is NOT recommended.
The endoscope and the needle must be
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perpendicular, not tangential, to the Elipse
Balloon before puncture is attempted.
6.2 Only if a dedicated aspiration needle and
two-pronged grasper are NOT available, perform
an endoscopic rupture of the Elipse Balloon.
This rupture procedure is slightly different depending
on if the Balloon is fully filled or partially filled.
If the Elipse Balloon is fully filled, the suggested
tool is a rat tooth forceps with alligator jaw
(e.g. US Endoscopy Raptor
1. Perform endotracheal intubation on patient.
2. Prepare patient for endoscopy per standard
hospital procedure.
3. Insert endoscope into patient's stomach.
4. Obtain a clear view of Balloon via the
endoscope.
5. Insert forceps through the endoscope
working channel.
6. Open and push forceps firmly perpendicular
to the film.
7. Close slowly to grab a large portion of film.
8. Pull forceps sharply to rip the film and create
a large hole.
9. Repeat steps 6, 7, and 8 until at least one
large or several small holes have been made
in the balloon.
10. Remove the forceps from the working channel.
11. Suction any liquid remaining in the stomach
and/or Balloon and withdraw endoscope.
12. Instruct patient to monitor stool for the torn
Balloon.
If the Elipse Balloon is partially filled, the suggested
tool is a biopsy forceps (e.g. Boston Scientific Radial
Jaw™ 4 Large Capacity Forceps with Needle).
1. Perform endotracheal intubation on patient.
2. Prepare patient for endoscopy per standard
hospital procedure.
3. Insert endoscope into patient's stomach.
4. Obtain a clear view of Balloon via the
endoscope.
5. Insert forceps through the endoscope
working channel.
6. Open and push forceps firmly perpendicular
to the film.
7. Close slowly to grab the film.
6
Grasping Device).
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